Clinical trial NCT04491630: COping With PAin Through Hypnosis, Mindfulness and Spirituality
Official title: COping With PAin Through Hypnosis, Mindfulness and Spirituality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Keywords: Experimental pain
Self-hypnosis
Mindfulness meditation
Christian prayer
Lead sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized 4-group, 196-subject experimental mixed-model repeated-measures study to:

1. 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;
2. to identify possible shared and unique predictors of response to the three treatment conditions.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
measure: Change in Pain Tolerance
timeFrame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Secondary outcomes:
measure: Change in Pain-related stress (Heart rate)
timeFrame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
measure: Change in Pain-related stress (Salivary cortisol level)
timeFrame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Other outcomes:
measure: Hypnotic suggestibility
timeFrame: Baseline
measure: Baseline mindfulness
timeFrame: Baseline
measure: Acceptance
timeFrame: Baseline
measure: Pain-related beliefs
timeFrame: Baseline
measure: Trait spirituality
timeFrame: Baseline
measure: Religiosity
timeFrame: Baseline
Locations:
city: Lisbon
country: Portugal
facility: ISPA
Study officials:
References:
citation: Ferreira-Valente A, Pimenta F, Costa RM, Day MA, Pais-Ribeiro J, Jensen MP. COPAHS Study: protocol of a randomised experimental study comparing the effects of hypnosis, mindfulness meditation, and spiritual practices on experimental pain in healthy adults. BMJ Open. 2021 Feb 8;11(2):e040068. doi: 10.1136/bmjopen-2020-040068.