COping With PAin Through Hypnosis, Mindfulness and Spirituality

Not Applicable

• Conditions: Pain, Acute
• Interventions: Behavioral: Christian Prayer (CP); Behavioral: Self-Hypnosis (SH); Behavioral: Mindfulness Meditation (MM)

• Registration Number: NCT04491630
• Lead Sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

Brief Summary

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.

Detailed Description

The primary aim of this study (Aim 1) is to compare the immediate effects of self-hypnosis (SH), mindfulness meditation (MM), and Christian meditation (CM), relative to a control group (CN), for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation in a sample of healthy volunteers.

An exploratory aim of this study (Aim 2) is to identify possible shared and unique predictors of response to the three treatment conditions. The possible predictors we plan to test include sex, age, religious affiliation, hypnotic suggestibility, baseline mindfulness, acceptance, pain-related beliefs, religiosity, trait spirituality, previous experience with SH, MM and CP, outcome expectancies, and trait absorption.

This is a randomized quantitative experimental mixed-model repeated-measures study with three assessment points: baseline (T0), pre-test (T1), and post-test (T2). Eligible healthy adults will be randomized to one of the four study conditions. Interventions will be a 20-minutes 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-minutes audio recording inducing one of the three interventions, or, in the case of the control group, to a 20-minutes recording of a natural history textbook. Primary outcomes are pain intensity, pain tolerance, and pain-related stress as measured by salivary cortisol level and heart rate variability.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29
• Study Start: 2020-09
• Primary Completion: 2021-09
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• 18 years old or older;
• able to read, speak and understand Portuguese;
• willing to be randomly assigned to all four conditions (regardless of participant's own religious affiliation)

Exclusion Criteria

• reporting history of musculoskeletal problems, cancer, heart disease, stroke, epilepsy, diabetes, or Raynaud syndrome;
• having an open wound, cut, or fracture in any of the upper limbs;
• self-reported alcohol or substance dependence;
• cognitive or physical impairment, or severe psychopathology that could prevent participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Christian prayer (CP)	Christian Prayer (CP)	-
Self-Hypnosis (SH)	Self-Hypnosis (SH)	-
Mindfulness meditation (MM)	Mindfulness Meditation (MM)	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Tolerance	Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)	Length (in seconds) that an individual bears painful stimulation
Change in Pain Intensity	Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)	0-10 Numerical Rating Scale

Secondary Outcome Measures

Name	Time	Method
Change in Pain-related stress (Heart rate)	Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)	Heart rate
Change in Pain-related stress (Salivary cortisol level)	Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)	Salivary cortisol level

Trial Locations

Locations (1)

ISPA; 🇵🇹 Lisbon, Portugal