COping With PAin Through Hypnosis, Mindfulness and Spirituality

Study Overview
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Brief Summary
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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
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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.

Official Title
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COping With PAin Through Hypnosis, Mindfulness and Spirituality

Conditions
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Pain, Acute

Intervention / Treatment
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* Behavioral: Self-Hypnosis (SH)
* Behavioral: Mindfulness Meditation (MM)
* Behavioral: Christian Prayer (CP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized 4-group, 196-subject experimental mixed-model repeated-measures study 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; to identify possible shared and unique predictors of response to the three treatment conditions.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-Hypnosis (SH)<br> | Behavioral: Self-Hypnosis (SH)<br>* Participants assigned to this condition will listen to a 20-minute recording with instructions of SH adapted from one of our team member's proposed model. First, the audio recording will introduce and orient the participant to SH. Then instruction in SH will be provided, including: (a) how to self-induce a hypnotic induction; (b) specific self-suggestions for comfort and ability to manage intense sensations; and (c) post-hypnotic suggestions that the participant will be easily able to use these hypnotic strategies on their own at a later time (i.e., in this case, during the Cold Pressor Arm Wrap procedures that will follow). A second 5-minute audio recording with instructions to guide the participant in SH will be provided during the second cycle of Cold Pressor Arm Wrap (CPAW).<br>|
| Active Comparator: Mindfulness meditation (MM)<br> | Behavioral: Mindfulness Meditation (MM)<br>* Participants in the MM condition will listen to a 20-minutes recording with instructions in the use and application of Vipassana MM, adapted from the manual developed by one of our team members. First, the audio recording will focus on introducing the idea of attention to their breath, and of non-judgmental monitoring and acceptance of the all events and stimuli. Then a guided MM (body scan) experience will be provided. A second 5-minute audio recording with instructions to facilitate the MM (body scan) experience taught in the first audio recording will be provided during the second cycle of CPAW.<br>|
| Active Comparator: Christian prayer (CP)<br> | Behavioral: Christian Prayer (CP)<br>* Participants in this condition will listen to a 20-minute recording with CP instructions. These instructions will be adapted from the existing on-line biblical meditations from the Society of Jesus (www.passo-a-rezar.net). First, the recording will introduce and orient the participant to CP. Then, a text of the Bible will be read twice, followed by a brief suggestion of prayer. A second 5-minute audio recording with instructions to facilitate the CP experience taught in the first audio recording, including the recording of a text of the Bible followed by a brief suggestion of meditation and relaxing music, will be provided during the second cycle of CPAW.<br>|
| No Intervention: Control condition (CN)<br>Participants in the CN condition will not be instructed to use any particular coping strategy to cope with the painful stimulation provided by the Cold Pressor Arm Wrap. Participants in the CN condition will listen to a 20-minute natural history audio recording. The option for this recording is supported by: (a) previous research showing that individuals who were asked to listen to it found it to be a neutral, yet relaxing, passage; (b) the use of this passage as an effective control condition in previous studies. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain-related stress (Heart rate) | Heart rate | Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention) | 
| Change in Pain-related stress (Salivary cortisol level) | Salivary cortisol level | Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Experimental pain, Self-hypnosis, Mindfulness meditation, Christian prayer