A comparison of two versus four sterile water injections for the relief of back pain in labour: A multicentre randomised equivalence trial.

BACKGROUND: Recent trials demonstrated the safety and efficacy of sterile water injections to provide relief from labour back pain. While four injections is the most common approach variations in technique, such as employing two injections, are also used. AIM: To determine if the analgesic effect of two sterile water injections is clinically equivalent to four. METHODS: 238 women in labour with a Visual Analogue Scale pain score (VAS) of 70 millimetres (mm) (0 = no pain; 100 = worst pain imaginable) were randomised to two or four sterile water injections. The primary outcome was pain measured on a VAS at 30 min post treatment. A priori margin of equivalence was set at ±10 mm. Secondary outcomes included the likelihood of achieving an at least 30% and 50% reduction in pain, birth and neonatal outcomes. RESULTS: At 30 min post-injection the difference in VAS scores between the techniques was -5.97 (95% Confidence Interval [CI] -13.18-1.22). As the lower end of the CI exceeds the margin of -10 mm equivalence was not demonstrated. Both techniques achieved an at least 30% reduction in pain in over 75% of participants though duration of effect was longer in the four injection group. There was no difference in other birth related secondary outcomes. CONCLUSION: Four injections provided a margin of benefit over two injections in level and duration of analgesia. DISCUSSION: Four injections remains the technique of choice though two injections still provided significant pain relief and would be suitable where it was not possible or desirable to provide four.

Mindfulness and its efficacy for psychological and biological responses in women with breast cancer.

Many breast cancer survivors have to deal with a variety of psychological and physiological sequelae including impaired immune responses. The primary purpose of this randomized controlled trial was to determine the efficacy of a mindfulness-based stress reduction (MBSR) intervention for mood disorders in women with breast cancer. Secondary outcomes were symptom experience, health status, coping capacity, mindfulness, posttraumatic growth, and immune status. This RTC assigned 166 women with breast cancer to one of three groups: MBSR (8 weekly group sessions of MBSR), active controls (self-instructing MBSR) and non-MBSR. The primary outcome measure was the Hospital Anxiety and Depression Scale. Secondary outcome measures were: Memorial Symptom Assessment Scale, SF-36, Sense of Coherence, Five Facets of Mindfulness Questionnaire, and Posttraumatic Growth Index. Blood samples were analyzed using flow cytometry for NK-cell activity (FANKIA) and lymphocyte phenotyping; concentrations of cytokines were determined in sera using commercial high sensitivity IL-6 and IL-8 ELISA (enzyme-linked immunosorbent assay) kits. Results provide evidence for beneficial effects of MBSR on psychological and biological responses. Women in the MBSR group experienced significant improvements in depression scores, with a mean pre-MBSR HAD-score of 4.3 and post-MBSR score of 3.3 (P = 0.001), and compared to non-MBSR (P = 0.015). Significant improvements on scores for distress, symptom burden, and mental health were also observed. Furthermore, MBSR facilitated coping capacity as well as mindfulness and posttraumatic growth. Significant benefits in immune response within the MBSR group and between groups were observed. MBSR have potential for alleviating depression, symptom experience, and for enhancing coping capacity, mindfulness and posttraumatic growth, which may improve breast cancer survivorship. MBSR also led to beneficial effect on immune function; the clinical implications of this finding merit further research.

The recovery process after day surgery within the symptom management theory.

PURPOSE: The aim was to illustrate two cases in a postoperative situation following day surgery within the framework of the symptom management theory. METHOD: Template analysis using the symptom management theory. RESULT: Neither the woman nor the man was able to return to their normal activities, health status or functional status, within a week. CONCLUSION: The results illustrate how a postoperative situation may involve personal suffering up to 3 months. PRACTICAL IMPLICATION: To obtain an outcome following day surgery, as optimal as possible, improving clinical practices and routines, such as discharge criteria, guidelines, and care pathways, is necessary.

Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer.

BACKGROUND: The stress of a breast cancer diagnosis and its treatment can produce a variety of psychosocial sequelae including impaired immune responses. Mindfulness Based Stress Reduction (MBSR) is a structured complementary program that incorporates meditation, yoga and mind-body exercises. Despite promising empirical evidence for the efficacy of MBSR, there is a need for randomized controlled trials (RCT). There is also a need for RCTs investigating the efficacy of psychosocial interventions on mood disorder and immune response in women with breast cancer. Therefore, the overall aim is to determine the efficacy of a Mindfulness Based Stress Reduction (MBSR) intervention on well-being and immune response in women with breast cancer. METHODS AND DESIGN: In this RCT, patients diagnosed with breast cancer, will consecutively be recruited to participate. Participants will be randomized into one of three groups: MBSR Intervention I (weekly group sessions + self-instructing program), MBSR Intervention II (self-instructing program), and Controls (non-MBSR). Data will be collected before start of intervention, and 3, 6, and 12 months and thereafter yearly up to 5 years. This study may contribute to evidence-based knowledge concerning the efficacy of MBSR to support patient empowerment to regain health in breast cancer disease. DISCUSSION: The present study may contribute to evidence-based knowledge concerning the efficacy of mindfulness training to support patient empowerment to regain health in a breast cancer disease. If MBSR is effective for symptom relief and quality of life, the method will have significant clinical relevance that may generate standard of care for patients with breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01591915.

Impact on caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial.

BACKGROUND: Sterile water injections have been used as an effective intervention for the management of back pain during labour. The objective of the current research is to determine if sterile water injections, as an intervention for back pain in labour, will reduce the intrapartum caesarean section rate. DESIGN: A double blind randomised placebo controlled trialSetting: Maternity hospitals in AustraliaParticipants: 1866 women in labour, ≥18 years of age who have a singleton pregnancy with a fetus in a cephalic presentation at term (between 37 + 0 and 41 + 6 weeks gestation), who assess their back pain as equal to or greater than seven on a visual analogue scale when requesting analgesia and able to provide informed consent. INTERVENTION: Participants will be randomised to receive either 0.1 to 0.3 millilitres of sterile water or a normal saline placebo via four intradermal injections into four anatomical points surrounding the Michaelis' rhomboid over the sacral area. Two injections will be administered over the posterior superior iliac spine (PSIS) and the remaining two at two centimetres posterior, and one centimetre medial to the PSIS respectively. MAIN OUTCOME MEASURE: Proportion of women who have a caesarean section in labour.Randomisation: Permuted blocks stratified by research site.Blinding (masking):Double-blind trial in which participants, clinicians and research staff blinded to group assignment. FUNDING: Funded by the National Health and Medical Research CouncilTrial registration:Australian New Zealand Clinical Trials Registry (No ACTRN12611000221954). DISCUSSION: Sterile water injections, which may have a positive effect on reducing the CS rate, have been shown to be a safe and simple analgesic suitable for most maternity settings. A procedure that could reduce intervention rates without adversely affecting safety for mother and baby would benefit Australian families and taxpayers and would reduce requirements for maternal operating theatre time. Results will have external validity, as the technique may be easily applied to maternity populations outside Australia. In summary, the results of this trial will contribute High level evidence on the impact of SWI on intrapartum CS rates and provide evidence of the analgesic effect of SWI on back pain.

Patients' experiences and perceived causes of persisting discomfort following day surgery.

BACKGROUND: The aim of this study was to describe patients' experiences and perceived causes of persisting discomfort following day surgery. Earlier research has mainly covered symptoms and signs during a recovery period of up to one month, and not dealt with patients' perceptions of what causes persisting, longer-term discomfort. METHODS: This study is a part from a study carried out during the period May 2006 to May 2007 with a total of 298 day surgery patients. Answers were completed by 118 patients at 48 hours, 110 at seven days and 46 at three months to one open-ended question related to discomfort after day surgery constructed as follows: If you are still experiencing discomfort related to the surgery, what is the reason, in your opinion? Data was processed, quantitatively and qualitatively. Descriptive, inferential, correlation and content analyses were performed. RESULTS: The results suggest that patients suffer from remaining discomfort e.g. pain and wound problem, with effects on daily life following day surgery up to three months. Among patients' perceptions of factors leading to discomfort may be wrongful or suboptimal treatment, type of surgery or insufficient access to provider/information. CONCLUSIONS: The results have important implications for preventing and managing discomfort at home following day surgery, and for nursing interventions to help patients handle the recovery period better.