Dataset Information

COPAHS Study: protocol of a randomised experimental study comparing the effects of hypnosis, mindfulness meditation, and spiritual practices on experimental pain in healthy adults.

ABSTRACT:

Background

There has been an increasing interest in studying the potential benefits of so-called complementary and alternative approaches for pain management, such as hypnosis and mindfulness-based interventions. More recently, researchers have been interested in studying the effects of spiritual practices on pain experience as well. These practices may increase pain tolerance, result in a positive re-appraisal of pain and influence other psychological variables that are known to be associated with pain experience. The purpose of this study is to evaluate and compare the immediate effects of self-hypnosis, mindfulness meditation, and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation.

Methods and analysis

Recruitment is anticipated to start in November 2020. This is a randomised quantitative experimental mixed-design repeated-measures study with three assessment points: baseline (T0), pre-test (T1) and post-test (T2). Eligible healthy adults will be randomised to one of the four study conditions. Interventions will be a 20-minute audio-guided practice of either self-hypnosis, mindfulness meditation, or Christian prayer. Participants in the control group will not be instructed to use any specific strategy during the painful stimulation. Participants will be submitted to a first cycle of Cold Pressor Arm Wrap. They will then listen to a 20-minute audio recording inducing one of the three interventions, or, in the case of the control group, to a 20-minute audio recording of text from a natural history textbook. Primary outcomes are pain intensity and pain tolerance. Pain-related stress as measured by salivary cortisol level and heart rate variability are secondary outcomes.

Ethics and dissemination

This study was approved by ISPA-University Institute's internal Ethics Committee for Research on 3rd December 2018 (reference I/010/12/2018). Findings will be published in peer-reviewed indexed journals and presented at conferences.

Trial registration number

ClinicalTrials.gov registry (NCT04491630). Stage: pre-results.

SUBMITTER: Ferreira-Valente A

PROVIDER: S-EPMC7871695 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

COPAHS Study: protocol of a randomised experimental study comparing the effects of hypnosis, mindfulness meditation, and spiritual practices on experimental pain in healthy adults.

Ferreira-Valente Alexandra A Pimenta Filipa F Costa Rui M RM Day Melissa A MA Pais-Ribeiro José J Jensen Mark P MP

BMJ open 20210208 2

<h4>Background</h4>There has been an increasing interest in studying the potential benefits of so-called complementary and alternative approaches for pain management, such as hypnosis and mindfulness-based interventions. More recently, researchers have been interested in studying the effects of spiritual practices on pain experience as well. These practices may increase pain tolerance, result in a positive re-appraisal of pain and influence other psychological variables that are known to be asso ...[more]

PMID: 33558346

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Project description:PurposePrevious research supports the usefulness of hypnosis (HYP), mindfulness meditation (MM), and prayer as pain self-management strategies in adults with chronic pain. However, their effects on acute pain have been less researched, and no previous head-to-head study compared the immediate effects of these three approaches on pain-related outcomes. This study compared the immediate effects of HYP, MM, and Christian prayer (CP) on pain intensity, pain tolerance, and stress as assessed by heart rate variability (HRV).Participants and methodsA total of 232 healthy adults were randomly assigned to, and completed, a single 20-minute session of MM, SH, CP, or an attention control (CN), and underwent two cycles (one pre- and one post-intervention) of Cold Pressor Arm Wrap (CPAW). Sessions were audio-delivered. Participants responded to pre- and post-intervention pain intensity measurements. Pain tolerance (sec) was assessed during the CPAW cycles. HRV was assessed at baseline, and at pre- and post-intervention CPAW cycles. The study protocol was pre-registered at the ClinicalTrials.gov registry (NCT04491630).ResultsSmall within-group decreases in pain intensity and small increases in pain tolerance were found for HYP and MM from the pre- to the post-intervention. Small within-group improvements in the LH/HF ratio were also found for HYP. The exploratory between-group pairwise comparisons revealed a medium effect size effects of HYP on pain tolerance relative to the control condition. The effects of CP were positive, but small and not statistically significant. Only small to medium, though non-significant, Time × Group interaction effects were found.ConclusionStudy results suggest that single short-term HYP and MM sessions, but not biblical-based CP, may be useful for acute pain self-management, with HYP being the slightly superior option. Future research should compare the effects of different types of prayer and examine the predictors and moderators of these pain approaches' effects on pain-related outcomes.

Project description:IntroductionHypertension (HTN) is a leading risk factor for preventable cardiovascular disease, with over one in five adults affected worldwide. Lifestyle modification is a key strategy for the prevention and treatment of HTN. Stress has been associated with greater cardiovascular risk, and stress management is a recommended intervention for hypertensives. Stress reduction through relaxation therapies has been shown to have an effect on human physiology, including lowering blood pressure (BP). However, individualised behavioural interventions are resource intensive, and group stress management approaches have not been validated for reducing HTN. The HARMONY Study is a pilot randomised controlled trial designed to determine if mindfulness-based stress reduction (MBSR), a standardised group therapy, is an effective intervention for lowering BP in stage 1 unmedicated hypertensives.Methods and analysisMen and women unmedicated for HTN with mean daytime ambulatory blood pressure (ABP) ≥135/85 mm Hg or 24 h ABP ≥130/80 mm Hg are included in the study. Subjects are randomised to receive MBSR immediately or after a wait-list control period. The primary outcome measure is mean awake and 24 h ABP. The primary objective of the HARMONY Study is to compare ABP between the treatment and wait-list control arm at the 12-week primary assessment period. Results from this study will determine if MBSR is an effective intervention for lowering BP in early unmedicated hypertensives.Ethics and disseminationThis research project was approved by the Sunnybrook Research Ethics Board and the University Health Network Research Ethics Board (Toronto, Canada). Planned analyses are in full compliance with the principles of the Declaration of Helsinki. Data collection will be completed by early spring 2012. Primary and secondary analysis will commence immediately after data monitoring is completed; dissemination plans include preparing publications for submission during the summer of 2012.Trial registration numberThis study is registered with http://clinicaltrials.gov (NCT00825526).

Dataset Information

COPAHS Study: protocol of a randomised experimental study comparing the effects of hypnosis, mindfulness meditation, and spiritual practices on experimental pain in healthy adults.

Background

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

COPAHS Study: protocol of a randomised experimental study comparing the effects of hypnosis, mindfulness meditation, and spiritual practices on experimental pain in healthy adults.

Similar Datasets

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