How do the activity patterns of people with chronic pain influence the empathic response of future health professionals: an experimental study.

Empathy in healthcare professionals is associated with better treatment outcomes and higher satisfaction among patients with chronic pain. Activity patterns play an essential role in the adjustment of these patients and, as a pain behaviour, may have a communicative function and elicit distinct empathic responses. This study investigated whether the activity pattern profiles characteristic of these patients had differential effects on the empathic response (empathic distress and compassion/sympathy) of future healthcare professionals. Healthcare professionals should improve their knowledge about the role of different activity patterns in the well-being of people with chronic pain and receive specific training in empathic skills. We controlled for several variables that could affect the empathic response (sex, age, academic degree, previous experience of chronic pain, and dispositional empathy).A total of 228 undergraduates performed an experimental task using vignettes depicting four activity pattern profiles displayed by people with chronic pain and completed questionnaires measuring dispositional and situational empathy. We conducted a MANCOVA analysis.Undergraduates showed more compassion/sympathy toward the medium cycler profile than toward the doer profile. Participants' age was associated with empathic distress. Sex, academic degree, and previous experiences with chronic pain were not associated with their empathic response to the vignettes. Dispositional perspective-taking and empathic concern were significantly associated with compassion/sympathy responses, and personal distress was significantly associated with empathic distress.Activity pattern profiles may have a communicative function and elicit different empathic responses toward people with chronic pain. Individual differences in dispositional empathy play an important role on situational empathic responses.

ANF therapy® for pain management, feasibility, satisfaction, perceived symptom reduction and side effects: a real-world multisite observational study.

[Purpose] Non-invasive and drug-free interventions for pain are being developed. One of them is ANF (which stands for "Amino Neuro Frequency") Therapy®, which consists in the application of carbonized metal devices on a patient's skin. We aimed to: 1) test perceived changes in pain intensity after ANF application, 2) record frequency and severity of side effects, 3) assess clinician and patient satisfaction, 4) explore effects on swelling and range of motion (ROM). [Participants and Methods] In this real-world multisite observational study, N=113 physical therapists in 45 countries, applied ANF to N=1,054 patients (Mage=45.2, 56.2% female) with pain complaints. Demographic data, pain intensity (NRS-11), effects of ANF on swelling and ROM, clinician and patient satisfaction and side effects were collected. [Results] Main pain locations were: low back (14.9%), knee (12.4%), neck (10%), and shoulder (9.6%). Pre-treatment pain intensity was high (Mean=7.6, SD=1.9). It significantly decreased post-treatment (Mean=3.1, SD=2.0), t(1053)=7.25, with a large effect size (Cohen's d=2.2). Swelling decreased and ROM increased. Average satisfaction with ANF was 92/100. Patients often experienced mild side effects (42.3%): dry mouth, headache and fatigue. [Conclusion] Results show large effect sizes, high satisfaction, and mild and short-term side effects. This is very promising but should be interpreted with caution considering the study limitations.

Intolerance of Uncertainty Moderates the Relationship between Catastrophizing, Anxiety, and Perceived Pain in People with Chronic Nononcological Pain.

OBJECTIVE: Substantial empirical evidence has shown that intolerance of uncertainty is a central transdiagnostic feature in psychopathology and it has been suggested to be a pain-related psychological factor contributing to the experience of chronic pain. However, research in this area is virtually nonexistent. The objective of this study was to investigate associations between pain severity, catastrophizing, and anxiety in people with chronic nononcological pain, while assuming that intolerance of uncertainty moderates these relationships. METHODS: A convenience sample of 188 individuals with nononcological chronic pain (157 women and 32 men) participated in the study. We investigated the moderated mediation of intolerance of uncertainty between anxiety and catastrophizing and between catastrophizing and pain intensity. RESULTS: The full moderated mediation model accounted for significant variance in pain intensity (R2 = 0.148, P< .001). Intolerance of uncertainty significantly moderated the interaction between anxiety and catastrophizing (B = 0.039, SE = 0.012, 95% CI [0.015, 0.063]) and between catastrophizing and pain intensity (B = -0.034, SE = 0.010, 95% CI [-0.054, -0.014]). Anxiety and intolerance of uncertainty did not interact in predicting catastrophizing, although an interaction effect was found between intolerance of uncertainty and catastrophizing in predicting pain intensity. CONCLUSION: This study is the first to address the interrelationship of intolerance of uncertainty, catastrophizing, and anxiety in relation to perceived pain intensity. The current findings support intolerance of uncertainty as a relevant psychological variable that is distinct from other relevant constructs in the setting of pain research and treatment.

The relevance of psychological strength for physical and psychological well-being in trauma-exposed women.

Traumatic experiences have consistently been linked to poor health and well-being, particularly in women. Psychological factors have been theorized to directly affect the reporting of physical symptoms and perceptions of general health. Posttraumatic stress disorder (PTSD) has been proposed as a major pathway through which trauma affects health and emotion dysregulation. Trauma is considered to be a key psychological variable in the pathogenesis of PTSD. Fortunately, not all women who have experienced trauma manifest adverse effects. Resilience acts as a psychological protective variable following trauma. The present study tested a hypothetical model of the contribution of resilience, emotional dysregulation, and PTSD symptoms to physical and psychological well-being in a large sample of trauma-exposed women. A transversal study with 753 female participants is used. Structural modeling was used to test linear associations between variables. After experiencing trauma, resilience was negatively and significantly associated with emotional dysregulation, which, in turn, was positively associated with PTSD symptoms. Both resilience and PTSD symptoms were associated with physical and psychological well-being. The results suggest that resilience and emotional dysregulation are relevant to the health and well-being of women with PTSD symptoms and may help guide the development of psychological treatment in this group. Therefore, these findings may be relevant in promoting health and well-being in such women, and may help to identify individuals who would receive the most benefit from interventions addressing emotional regulation and psychological resilience.

The Relationship Between Experiential Avoidance and Posttraumatic Stress Symptoms: A Moderated Mediation Model Involving Dissociation, Guilt, and Gender.

Experiential avoidance, dissociation, and guilt have been shown to be associated with trauma exposure and to play an important role in explaining the development and maintenance of posttraumatic stress symptoms. However, there is a lack of studies that simultaneously address the relationship between these variables, which has never been studied within the framework of emotional processing theory. Furthermore, gender differences in traumatic victimization, posttraumatic stress symptoms, experiential avoidance, dissociation, and guilt have also been reported. Therefore, this study had a double aim: a) to assess the mediating roles of dissociation and guilt in the relationship between experiential avoidance and posttraumatic stress symptoms; and b) to investigate whether gender moderates any such relationship. The final sample comprised 683 undergraduate students (150 men and 533 women) with a history of exposure to traumatic events and with posttraumatic stress symptoms. Mediation and moderated mediation analyses were conducted. Dissociation and guilt independently mediated the association between experiential avoidance and posttraumatic stress symptoms: however, this mediation effect was not moderated by gender. The findings suggest that interventions aimed at controlling psychological variables linked to PTSD (i.e. experiential avoidance, dissociation, and guilt) may be of help to both men and women.

Using vignettes to assess the contribution of goal adjustment in the adaptation to chronic musculoskeletal pain.

PURPOSE: The quality of life of individuals with chronic musculoskeletal pain partly depends on their capacity to adjust their personal goals. Vignettes have been rarely used to assess this ability. Therefore, this study aimed to test the relationships between vignettes assessing different goal strategies and chronic pain adaptation (i.e., daily functioning, pain-related impairment, and psychological well-being). METHODS: The sample comprised 258 individuals with chronic musculoskeletal pain who completed a series of questionnaires and vignettes. The vignettes presented a short description of a situation in which a person with chronic pain experienced a threat to a valued domain-specific goal and had to choose a possible goal management solution (i.e., goal persistence, flexibility reengagement, and disengagement). Hierarchical regression analyses were used to predict chronic pain adaptation using the selected vignette strategies as predictors. RESULTS: After controlling for age, sex, pain intensity, and the responses to the dispositional goal management scales, persistence, reengagement, and disengagement goal strategies presented in the case scenarios predicted daily functioning (p < .001). Persistence, flexibility, disengagement (p < .001), and reengagement (p < .05) predicted pain-related impairment. Persistence, disengagement (p < .001), and flexibility (p < .05) predicted psychological well-being scores. CONCLUSION: The use of vignettes could be useful to assess goal adjustment because this methodology enables respondents to provide more context-specific responses. The results of this approach could be used to improve clinical practice aimed at helping people with chronic musculoskeletal pain to better cope with this health condition.

Goal Adjustment and Well-Being: The Role of Optimism in Patients with Chronic Pain.

BACKGROUND: Chronic pain directly or indirectly interferes with valued personal goals. Goal adjustment plays a central role in patients' adaptation. Studies on the relationship between optimism and goal regulation have shown that people with high dispositional optimism adjust their goals in a flexible way, and that flexible goal adjustment promotes quality of life. PURPOSE: The aim of this study was to analyze the relationship among optimism, goal adjustment, and adaptation in patients with chronic pain. METHODS: A sample of 258 patients with chronic musculoskeletal pain completed questionnaires on optimism, reengagement, disengagement, flexibility, tenacity, rumination, purpose in life, well-being, pain intensity, daily functioning, and impairment. RESULTS: Structural equation modeling analysis showed that optimism had a positive association with reengagement, flexibility, and tenacity, and a negative association with disengagement. Disengagement was positively associated with rumination, whereas reengagement, flexibility, and tenacity were associated with higher levels of purpose in life, which were strongly associated with adaptation in patients with chronic pain. CONCLUSIONS: This study supports the conclusions of previous research on the role of goal adjustment as a mediator variable between optimism and well-being.

Resilience and Vulnerability Factors When Pain is Acute as Predictors of Disability: Findings From a Two-Year Longitudinal Study.

OBJECTIVE: To investigate the predictive power of resilience and vulnerability factors in relation to pain-related disability. DESIGN: A two-year prospective study investigated whether back pain-related disability was predicted by the following variables, measured when pain was acute: 1) pain-related disability, 2) pain intensity, 3) depression, 4) fear avoidance beliefs, 5) anxiety sensitivity, and 6) resilience. METHODS: Two hundred thirty-two patients treated in five primary care centers participated in this study. They were assessed at baseline during an acute back pain episode and at six, 12, 18, and 24 months. Ninety-nine patients completed all the assessment sessions. Linear mixed models were used to examine the trajectory of disability across the measurement occasions and its association with the predictors. RESULTS: Individuals who had higher scores of disability and pain intensity when pain was acute also had higher scores of disability six months later; moreover, the increase in disability was greater over time in comparison with individuals with lower scores in disability and pain intensity when pain was acute. Individuals who had reported greater levels of fear avoidance beliefs when pain was acute also reported greater scores of disability six months later; however, no differences were found in the rate of change in disability. No associations were found between initial disability or rate of change and resilience, anxiety sensitivity, or depression. CONCLUSIONS: Patients with acute back pain who show high levels of pain-related disability, pain intensity, and fear avoidance beliefs are at risk of developing back pain-related disability and should be the target of a preventive intervention.

A confirmatory factor analysis of the Resilience Scale adapted to chronic pain (RS-18): new empirical evidence of the protective role of resilience on pain adjustment.

PURPOSE: Recent attention has focused on resilience as an important process in the experience and management of chronic pain. In this context, resilience is considered as a psychological factor that promotes adaptive responses to pain and pain-related life adversities. Current research suggests that it is a relevant variable in the prediction of pain adjustment among chronic pain patients. Recently, it was adapted the Resilience Scale to patients suffering chronic musculoskeletal pain (RS-18). The aims of this study were to confirm the internal structure of the RS-18 and to present new empirical evidence regarding its validity. METHODS: A sample of 592 patients with chronic musculoskeletal back pain completed a battery of instruments to assess resilience, anxiety sensitivity, catastrophizing, fear-avoidance beliefs, hypervigilance, pain acceptance, and pain adjustment variables (pain intensity, emotional distress, functional impairment, and daily functioning). RESULTS: Confirmatory factor analysis supported the validity of the RS-18 and a single-factor solution. A series of moderated multiple regression analysis showed that resilience is a relevant psychological variable that not only independently predicts better pain adjustment, but also moderates the relationships between several psychological pain-related variables and pain adjustment variables. CONCLUSIONS: These findings give empirical support to the consideration of resilience as a protective variable in chronic pain adjustment and highlight the consideration that improving resilient behaviour could be an important target for the treatment of pain patients.

Fear-avoidance, pain acceptance and adjustment to chronic pain: a cross-sectional study on a sample of 686 patients with chronic spinal pain.

BACKGROUND: Prior studies found a range of psychological factors related to the perception of pain, maintenance of pain and disability. PURPOSE: The aim of this study was to investigate the role of pain fear-avoidance and pain acceptance in chronic pain adjustment. The influence of two diathesis variables (resilience and experiential avoidance) was also analyzed. METHODS: The sample was composed of 686 patients with chronic spinal pain. Structural equation modelling analyses were used to test the hypothetical model. RESULTS: Experiential avoidance was associated with pain fear-avoidance, and resilience was strongly associated with pain acceptance. Pain acceptance was negatively associated with negative mood, functional impairment and pain intensity. However, pain fear-avoidance was positively and significantly associated with negative mood but had no association with pain intensity. There was a path from functional impairment to pain fear-avoidance. CONCLUSIONS: Resilience and experiential avoidance appear as variables which could explain individual differences in pain experience.

Vulnerability Factors, Adjustment, and Opioid Misuse in Chronic Noncancer Pain Individuals.

Several person variables predate injury or pain onset that increase the probability of maladjustment to pain and opioid misuse. The aim of this study was to evaluate the role of 2 diathesis variables (impulsiveness and anxiety sensitivity [AS]) in the adjustment of individuals with chronic noncancer pain and opioid misuse. The sample comprised 187 individuals with chronic noncancer pain. The hypothetical model was tested using correlation and structural equation modeling analyses. The results show a significant association between impulsiveness and AS and all the maladjustment variables, and between impulsiveness and AS and opioid misuse and craving. However, although the correlation analysis showed a significant association between adjustment to pain and opioid misuse, the structural equation modeling analysis showed a nonsignificant association between them (as latent variables). The findings support the hypothesis that both impulsiveness and AS are vulnerability factors for maladaptive adjustment to chronic pain and opioid misuse. PERSPECTIVE: This article adds to the empirical literature by including AS and impulsiveness as antecedent variables in a model of dual vulnerability to chronic pain maladjustment and opioid misuse. The findings suggest the potential utility of assessing both factors in individuals in the first stages of chronic pain.

Measuring Pain-related Behavioral Inhibition and Behavioral Activation System Responses: Further Validity Evidence for the Pain Responses Scale.

OBJECTIVES: The Pain Responses Scale and its Short Form (PRS-SF) were recently developed to assess the affective, behavioral, and cognitive responses to pain based on the behavioral inhibition system (BIS) and behavioral activation system (BAS) model of chronic pain. The purpose of this study was to provide additional tests of the psychometric properties of the PRS-SF in a new sample of individuals with chronic pain. METHODS: A sample of Spanish adults (N = 190) with chronic non-cancer pain completed a translated version of the PRS-SF and a battery of questionnaires measuring validity criteria hypothesized the be associated with BIS and BAS activation, including measures of sensitivity to punishment, sensitivity to reward, pain intensity, pain interference, catastrophizing, and pain acceptance. RESULTS: Confirmatory factor analysis supported a 4-factor structure for the PRS-SF assessing despondent, escape, approach, and relaxation responses (S-B χ 2 [5] = 1.49, Comparative Fit Index = 0.99, Non-Normed Fit Index = 0.99, root-mean-square error of approximation = 0.051, Akaike Information Criterion = 4113.66), with marginal internal consistency for 1 scale (relaxation) and adequate to good internal consistency for the others. The pattern of associations found between the PRS-SF Scale scores and the validity criterion supports the validity of the instrument. CONCLUSION: The results provide additional support for the validity of the 4 PRS-SF Scale scores, and the reliability of 3 of the scales. If these findings are replicated in future research, investigators may wish to administer more items from the original Relaxation Scale when assessing this domain to ensure adequate reliability for this scale. The other items from the PRS-SF assessing despondent, escape, and approach responses appear to provide at least adequate reliability. When used in this way, the PRS-SF may be used to measure BIS and BAS responses to pain to: (1) provide further tests of the BIS-BAS model of chronic pain and/or (2) understand the potential mediating effects of BIS and BAS responses on the effects of psychological pain treatments to help determine which specific responses are most responsible for the benefits of treatment, and, therefore, which responses should be specifically targeted to enhance treatment response.

Virtual Reality Distraction for Needle-Related Pain and Distress in Children: A Multicenter Randomized Controlled Trial.

This international multicenter randomized controlled trial aimed to compare the effectiveness of virtual reality (VR) distraction with an identical non-VR game in reducing needle-related pain and anxiety in children undergoing venous blood draw. The study involved 304 children aged 5-9 years undergoing a blood draw procedure, randomly allocated to one of three groups: VR distraction, non-VR distraction, and control group (usual care). The distraction task was based on the Multiple Object Tracking (MOT) paradigm, and the game was identical in design and gameplay for both VR and non-VR distraction groups. The primary outcome was self-reported pain intensity using the Faces Pain Scale-Revised (FPS-R). Secondary outcomes included child distress, attention/distraction to the blood draw, and parent and medical staff satisfaction with procedure. Analyses were conducted using analysis of variance and multivariable linear regression models. The results showed that VR distraction and non-VR distraction performed similarly, showing large effect sizes compared with standard care. There was no significant difference between the two types of distraction. The study's findings suggest that VR and non-VR distraction are similarly effective in reducing needle-related pain and anxiety in children undergoing venous blood draw. This is the first well-powered study comparing modern VR distraction with an identical task displayed on a smartphone or monitor screen. The study's results have important implications for using VR in clinical settings and suggest that investing in expensive VR equipment for acute pain management may not be necessary. The study protocol was pre-registered on Open Science Framework at https://osf.io/frsyc.

Pain fear avoidance and pain acceptance: a cross-sectional study comparing their influence on adjustment to chronic pain across three samples of patients.

BACKGROUND: Prior studies found that pain fear avoidance and pain acceptance are significantly associated with adjustment to chronic pain. PURPOSE: The purpose of this study is to compare the influence of pain fear avoidance and pain acceptance on adjustment to chronic pain across three samples: patients with chronic back pain treated at primary care centres, patients with heterogeneous pain conditions treated at a pain clinic and patients with pain associated with inflammatory bowel disease. METHODS: Structural equation modelling was used to test for differences between groups in the linear relationships between variables. RESULTS: The model had the best fit for the group of patients with back pain. Three significant relationships were equal across the groups: experiential avoidance on pain fear avoidance, pain intensity on pain fear avoidance, and pain fear avoidance on negative mood. CONCLUSIONS: The associations between both pain fear avoidance and pain acceptance and adjustment to chronic pain vary depending on the pain condition and the type of health care centres where the patients are treated.

Disposition and adjustment to chronic pain.

Several empirical studies have shown that personal characteristics act as differential variables, which determine how pain is experienced and how the chronic pain patient adjusts to pain. The main aim of the present research is to review the relationships between some dispositional characteristics and pain adjustment. Taking into account the empirical literature, 6 personality traits that are relevant to the pain experience have been selected: neuroticism, anxiety sensitivity, and experiential avoidance as risk factors that increase the probability of patients experiencing a disability; and extraversion, optimism, and resilience as personal resources that increase their capacity to manage pain effectively. The results suggest that it would be useful to include an assessment of normal personality structure during the multi-dimensional evaluation of a person with chronic pain. Understanding these individual personality characteristics will aid in designing pain intervention programs and help predict possible treatment outcomes.

Distress intolerance and pain catastrophizing as mediating variables in PTSD and chronic noncancer pain comorbidity.

OBJECTIVES: Several studies have demonstrated posttraumatic stress disorder (PTSD) and chronic pain comorbidity. However, there is a lack of research on the psychological variables that might explain their co-occurrence. We investigated the mediating role of distress intolerance and pain catastrophizing in this relationship. METHODS: A moderated mediation model was tested. The sample comprised 114 individuals with chronic noncancer pain (90 women and 24 men; mean age, of 60.04 years [SD=9.76]). RESULTS: Catastrophizing had a significant effect on PTSD. Distress intolerance mediated catastrophizing and PTSD, and pain intensity moderated this relationship. CONCLUSIONS: New insights are provided into the psychological variables that may explain PTSD and chronic noncancer pain comorbidity.

Empathy among health science undergraduates toward the diagnosis of chronic pain: An experimental study.

OBJECTIVES: To analyse the empathetic response of future health professionals toward people diagnosed with chronic pain differentiated by the degree of visibility and credibility of symptoms. METHODS: A total of 203 undergraduates performed an experimental task using vignettes depicting different diagnoses of chronic pain and completed questionnaires measuring dispositional and situational empathy. A MANCOVA analysis was conducted. RESULTS: The main effects of chronic pain diagnoses did not significantly affect situational empathy (p = .587, η2 = 0.007, d = 0.229). The dispositional empathy variables perspective-taking and personal distress affected the situational empathy scores (p = .002, η2 = 0.072, d = 0.906, and p = .043, η2 = 0.032, d = 0.547, respectively). CONCLUSIONS: It would seem appropriate to foster intra-individual empathy factors among health science undergraduates such that they can more readily understand the process of individual adaptation to chronic pain and thus manage it more effectively. PRACTICE IMPLICATIONS: It would be useful for dispositional empathy to form part of the transversal competences of the training programmes of future health professionals from the beginning of their studies.

Physicians' perception about predictors of opioid abuse in patients with chronic non-cancer pain: a Delphi study.

Background: Opioids are being prescribed widely, and increasingly, for the treatment of chronic non-cancer pain (CNCP). However, several side effects are associated with mid- and long-term opioid use and, for certain patients, with the risk of problematic opioid use. The aim of this study is to know the perception of the physicians about which variables could be associated with increased risk of patients with CNCP developing a problem of abuse or misuse of the prescribed opioid medication. Methods: Twenty-nine physicians with experience in CNCP pain management and opioids prescription participated in a two-round Delphi study focused on the risk factors for opioid misuse and abuse. Results: The variables that reached consensus regarding their relationship with the increased risk of suffering a problem of opioid abuse or misuse were: (1) Experiencing pain on a daily basis, (2) previous use of high-dose opioids, (3) generalized anxiety, (4) hopelessness, (5) benzodiazepine intake, (6) use of opioids for reasons other than pain, (7) family problems, family instability or family breakdown, and (8) having access to several opioid prescribers. The only variable that reached consensus regarding it not being associated to a possible risk of abuse or misuse was having mild pain intensity (0-4 on a NRS-11). Conclusions: This study provides useful information that could help make decisions about the use of opioids for CNCP treatment and prevent future difficulties. Prospective studies testing the relationship of the variables that reached consensus with the risk of opioid misuse and abuse are warranted. Significance: This study shows the variables of CNCP that the professional must take into account in order to avoid possible problems when prescribing opioids.

Does pain catastrophizing and distress intolerance mediate the relationship between PTSD and prescribed opioid misuse in people with chronic noncancer pain?

OBJECTIVE: There is an ongoing debate on the use of long-term high-dose medically prescribed opioid analgesics for patients with chronic noncancer pain. Such use is elevated when there is comorbid pain and PTSD, which is quite prevalent. Therefore, it is relevant to investigate the psychological variables that may explain opioid misuse in this population. The purpose of this study was to examine the interaction effect of PTSD severity, distress intolerance, and pain catastrophizing on prescribed opioid misuse in chronic noncancer pain patients. METHOD: A total of 168 participants (M age = 60 years, 74% women) were assessed regarding opioid medication, pain intensity, traumatic psychological events, PTSD, distress intolerance, pain catastrophizing, and current opioid misuse. RESULTS: Groups were formed according to the level of PTSD severity (no symptoms, moderate symptoms, and severe symptoms). Significant differences were found between the groups in pain intensity, catastrophizing, distress intolerance, and opioid misuse. The severe-symptoms group had the highest scores on all variables. There were no between-group differences in the prescribed medication. Mediation analysis showed that the relationship between PTSD severity and opioid misuse was completely and independently mediated by distress intolerance and pain catastrophizing. CONCLUSIONS: Distress intciolerance and pain catastrophizing may be theoretically and clinically relevant constructs in understanding the motivation for opioid misuse in people with concurrent chronic noncancer pain and PTSD. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA).

Background: Children and adolescents with chronic pain are a vulnerable population who often lack the resources to manage their condition. Due to high personal, social, and economic consequences, proper management in its early stages is key to reducing disability. The aim of this project is to co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users and to evaluate its effectiveness and implementation outcomes in Spain. Methods: (Phase 1) Focus groups with patients, parents, and clinicians (n = 5-6 each) will inform about unmet pain care needs and provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based on the results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validated psychological techniques focused on improving functioning by teaching pain coping skills. (Phase 3) Hybrid effectiveness-implementation trial. Participants (n = 195) will be adolescents aged 12-17 years old with chronic pain and one of their parents. Assessments include physical function, pain, sleep, anxiety, mood, satisfaction and adherence to the treatment, and number of visits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the intervention will be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) and Behavioral Interventions Using Technology (BIT) frameworks will be used to evaluate implementation. Discussion: This study is expected to produce a co-created evidence-based digital intervention for pediatric chronic pain and a roadmap for successful implementation. Trial registration number TRN and date of registration: ClinicalTrials.gov (registered on 26 June 2023: https://clinicaltrials.gov/study/NCT05917626). Contributions to the literature The implementation of digital health interventions has two major gaps: (1) adherence to treatment is suboptimal, and (2) the process of making the interventions available to the end-user in a sustainable way is often unsuccessful.In this study, we expect that assessing users' needs and co-designing an intervention with them will improve adherence.Documenting the implementation process from the project inception and integrating the results into an implementation framework will allow for replication and extension in different contexts.This study will increase the knowledge about implementation in a vulnerable population: adolescents with chronic pain without access to in-person multidisciplinary pain care.