The impact of spiritual care delivered by nurses on patients' comfort: A propensity score matched cohort utilizing electronic health record data.

BACKGROUND: Spiritual care has been associated with better health outcomes. Despite increasing evidence of the benefits of spiritual care for older patients coping with illness and aggressive treatment, the role of spirituality is not well understood and implemented. Nurses, as frontline holistic healthcare providers, are in a position to address patients' spiritual needs and support them in finding meaning in life. This study aimed to identify spiritual care by analyzing nursing data and to compare the psychological and physical comfort between older chronically ill patients who received spiritual care versus those who did not receive spiritual care. MATERIAL AND METHODS: A propensity score matched cohort utilizing nursing care plan data was used to construct balanced groups based on patient characteristics at admission. 45 older patients (≥65 years) with chronic illnesses received spiritual care with measured psychological or physical comfort and 90 matched controls. To ensure the robustness of our results, two sensitivity analyses were performed. Group comparisons were performed to assess the average treatment effect of spiritual care on psychological and physical comfort outcomes. RESULTS: The mean psychological comfort was 4.3 (SD = 0.5) for spiritual care receivers and 3.9 (SD = 0.9) for non-receivers. Regression analysis showed that spiritual care was associated with better psychological comfort (estimate = 0.479, std. error = 0.225, p = 0.041). While its effect on physical comfort was not statistically significant (estimate = -0.265, std. error = 0.234, p = 0.261). This study provides suggestive evidence of the positive impact of nurses' spiritual care in improving psychological comfort for older patients with chronic illnesses. CONCLUSION: Using interoperable nursing data, our findings suggest that spiritual care improves psychological comfort in older patients facing illness. This finding suggests that nurses may integrate spiritual care into their usual care to support patients experiencing distress.

Women's Experience of Living with Vulvodynia Pain: Why They Participated in a Randomized Controlled Trial of Acupuncture.

Introduction: Vulvodynia is vulvar pain lasting at least 3-months without clear identifiable cause that may have other associated factors. The aim, to explore motivations of women participating in a double-blind randomized controlled trial of acupuncture for vulvodynia. Methods: Responses to the question: "Tell me about why you decided to participate in this study" were analyzed using conceptual content analysis to identify patterns in motivation for study participation. Results: Four patterns emerged: 1) desire to address uncontrolled pain, 2) desire for understanding, 3) wish to contribute to knowledge generation, and 4) need to remove cost barriers. Conclusion: Motivations indicate vulvodynia-specific aspects of acceptability of acupuncture. Clinical Trial Registration: NCT03364127.

Protocol for double-blind RCT of acupuncture for vulvodynia.

Background: Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia. Aims are to: 1) determine efficacy of acupuncture for vulvodynia, 2) explore duration of the acupuncture effect. Methods: In a pretest/posttest randomized controlled, double-blind (practitioner-patient) efficacy trial of a standardized acupuncture protocol, we will randomize 80 participants 1:1 to either penetrating needle or skin-touch placebo needle groups. Both types of needles are designed to blind both the acupuncturist and participant. Participants with vulvodynia will insert and remove a tampon as a standardized stimulus and complete primary measures of vulvar pain (pain intensity) and secondary measures of dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) pretreatment, after the 10th acupuncture session, and pain measures weekly until return to pretest levels. Upon study completion control group participants will be offered 10 free real acupuncture sessions. Discussion: This is the first multi-needle multi-session RCT using double-blind acupuncture needles as a reliable sham. We hypothesize that controlling for baseline, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over five weeks in the penetrating needle group compared to the skin touch placebo group. Conclusion: This study is responsive to the need for efficacious pain management for women with vulvodynia.ClinicalTrials.gov Identifier: NCT03364127.

Feasibility and Burden of Lay Caregivers Providing Daily Massages to Patients With Cancer Receiving Hospice and Palliative Care.

Professional massages reduce symptoms experienced by cancer patients, but are costly. A cost-effective way to include this therapy routinely in hospice care is to teach family caregivers to give massages as part of their caregiving activities. However, the burden on caregivers is unknown and might offset patient benefits or cost savings. The pilot study aim was to explore feasibility issues related to licensed massage therapists training caregivers to give massages at home, the burden of giving four daily massages to hospice patients, and feedback about the training and massage delivery. In this pretest/posttest study, caregivers completed the Caregiver Reaction Assessment (CRA), received training on standardized massage techniques from a licensed massage therapist who evaluated their proficiency the following day. Caregivers gave daily massages for 3 days and afterward completed the CRA. Then a researcher interviewed the dyad for feedback about the training and massage delivery. We used paired t tests to evaluate CRA scores and content analysis of interview data. Thirty-nine caregivers (mean age = 46 years, 69% female) completed the study. After training, all but three caregivers provided daily massages. Some caregivers reported minor logistical challenges in massage delivery and documentation, mutual satisfaction, relaxation, and tender moments ranging from laughter and story sharing to closure activities. Mean CRA scores were not significantly different pretest to posttest. We conclude that repeated-dose massages by caregivers to patients dying of cancer is feasible and is worthy of further study to determine the benefits of massage therapy, caregiver and patient experiences, and caregiver burden.

Spiritual Interventions Delivered by Nurses to Address Patients' Needs in Hospitals or Long-Term Care Facilities: A Systematic Review.

Introduction: Despite increasing evidence of the benefits of spiritual care and nurses' efforts to incorporate spiritual interventions into palliative care and clinical practice, the role of spirituality is not well understood and implemented. There are divergent meanings and practices within and across countries. Understanding the delivery of spiritual interventions may lead to improved patient outcomes. Aim: We conducted a systematic review to characterize spiritual interventions delivered by nurses and targeted outcomes for patients in hospitals or assisted long-term care facilities. Methodology: The systematic review was developed following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, and a quality assessment was performed. Our protocol was registered on PROSPERO (Registration No. CRD42020197325). The CINAHL, Embase, PsycINFO, and PubMed databases were searched from inception to June 2020. Results: We screened a total of 1005 abstracts and identified 16 experimental and quasi-experimental studies of spiritual interventions delivered by nurses to individuals receiving palliative care or targeted at chronic conditions, such as advanced cancer diseases. Ten studies examined existential interventions (e.g., spiritual history, spiritual pain assessment, touch, and psychospiritual interventions), two examined religious interventions (e.g., prayer), and four investigated mixed interventions (e.g., active listening, presence, and connectedness with the sacred, nature, and art). Patient outcomes associated with the delivery of spiritual interventions included spiritual well-being, anxiety, and depression. Conclusion: Spiritual interventions varied with the organizational culture of institutions, patients' beliefs, and target outcomes. Studies showed that spiritual interventions are associated with improved psychological and spiritual patient outcomes. The studies' different methodological approaches and the lack of detail made it challenging to compare, replicate, and validate the applicability and circumstances under which the interventions are effective. Further studies utilizing rigorous methods with operationalized definitions of spiritual nursing care are recommended.

Prevalence, Predictors and Correlates of Religious and Spiritual Struggles in Palliative Cancer Patients.

CONTEXT: Religion and spirituality (r/s) are important resources in coping with cancer. However, there are aspects of r/s, such as religious and spiritual struggles, found to be associated with poorer outcomes. A new measure has been adapted from the Religious and Spiritual Struggles Scale (RSS) to assess r/s struggles: the RSS-14. This concise measure allows for the assessment of multiple types of r/s struggles for people from different religious backgrounds or none. OBJECTIVES: The aim of the present study was to examine the prevalence, predictors and correlates of r/s struggles as measured by the RSS-14 and its subdomains in a cancer population receiving palliative care. METHODS: Data were collected from six outpatient palliative care services across the US. Inclusion criteria for patients were age 55 or older with a cancer diagnosis. In addition to demographic and r/s characteristics, study measures included the Edmonton Symptom Assessment Scale (ESAS), the Patient Dignity Inventory (PDI) and the Quality of Life at the End of Life (QUAL-E). RESULTS: The study included 331 participants. Some r/s struggle was reported by 66%, moderate to high struggle for at least one item was reported by 20% of the patients. In bivariate analyses, r/s struggle was associated with greater symptom burden, greater dignity-related problems and poorer quality of life; in multivariable analyses, dignity-related problems remained a predictor of total r/s struggle. CONCLUSION: R/S struggles may compromise well-being for cancer patients receiving palliative care. Clinicians should consider periodic screening for r/s struggles and referrals for spiritual care if indicated.

Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

BACKGROUND: Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. METHODS: Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. RESULTS: At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. DISCUSSION: Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.

AIM: To test feasibility of a guided audio-visual relaxation intervention protocol for reducing stress and pain in adults with sickle cell disease. BACKGROUND: Sickle cell pain is inadequately controlled using opioids, necessitating further intervention such as guided relaxation to reduce stress and pain. DESIGN: Attention-control, randomized clinical feasibility pilot study with repeated measures. METHODS: Randomized to guided relaxation or control groups, all patients recruited between 2013-2014 during clinical visits, completed stress and pain measures via a Galaxy Internet-enabled Android tablet at the Baseline visit (pre/post intervention), 2-week posttest visit and also daily at home between the two visits. Experimental group patients were asked to use a guided relaxation intervention at the Baseline visit and at least once daily for 2 weeks. Control group patients engaged in a recorded sickle cell discussion at the Baseline visit. Data were analysed using linear regression with bootstrapping. RESULTS: At baseline, 27/28 of consented patients completed the study protocol. Group comparison showed that guided relaxation significantly reduced current stress and pain. At the 2-week posttest, 24/27 of patients completed the study, all of whom reported liking the study. Patients completed tablet-based measures on 71% of study days (69% in control group, 72% in experiment group). At the 2-week posttest, the experimental group had significantly lower composite pain index scores, but the two groups did not differ significantly on stress intensity. CONCLUSION: This study protocol appears feasible. The tablet-based guided relaxation intervention shows promise for reducing sickle cell pain and warrants a larger efficacy trial. TRIAL REGISTRATION: The ClinicalTrials.gov Identifier is: NCT02501447.

Mechanism-driven phase I translational study of trifluoperazine in adults with sickle cell disease.

Recent evidence of neuropathic pain among adults with sickle cell disease (SCD) reveals a need for adjuvant analgesic treatments for these patients. Ca(2+)/calmodulin protein kinase IIα (CaMKIIα) has a known role in neuropathic pain and trifluoperazine is a potent CaMKIIα inhibitor. The study aim was to determine trifluoperazine's acute effects, primarily on adverse effects and secondarily on pain intensity reduction, in adults with SCD. In a phase I, open-label study of 6 doses of trifluoperazine (0.5, 1, 2, 5, 7.5, 10mg), we obtained 7-hourly and 24-h repeated measures of adverse effects, pain intensity, and supplemental opioid analgesics in 18 adults with SCD (18 hemoglobin SS disease, 15 women, average age 35.8±8.9 years, ranged 23-53) each of whom received a single dose. Data were analyzed with descriptive statistics. Subjects reported moderate to severe sedative effects at 7.5 and 10mg doses, respectively. Eight subjects reported 50% reduction in chronic pain without severe sedation or supplemental opioid analgesics; one of these subjects had dystonia 24.5h after the 10mg dose. The analgesic effect lasted for at least 24h in 3 subjects. Sedation resolved with caffeine and dystonia resolved with diphenhydramine. Adults with SCD experienced minimal adverse effects at doses under 10mg. In this molecular mechanism-driven translational study, trifluoperazine shows promise as an analgesic drug that is worthy of further testing in a randomized controlled study of adults with SCD starting at a dose of 1mg in repeated doses to determine long-term adverse and analgesic effects.