COping With PAin Through Hypnosis, Mindfulness and Spirituality

Pain, Acute Clinical Trial

— COPAHS  

Official title:

COping With PAin Through Hypnosis, Mindfulness and Spirituality

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04491630
• Other study ID #: ISPA
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: March 2022

Study information

• Verified date: July 2020
• Source: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
• Contact: Alexandra Ferreira-Valente, PhD
• Phone: +351969082988
• Email: mafvalente[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 196
• Est. completion date: March 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Behavioral:
• Self-Hypnosis (SH)
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).
• Mindfulness Meditation (MM)
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.
• Christian Prayer (CP)
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.

Locations

Country	Name	City	State
Portugal	ISPA	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypnotic suggestibility	Barber Suggestibility Scale (BSS). Objective scoring ranges from 0 to 8, and the subjective score ranges from 0 to 24. Higher scores indicate higher levels of hypnotic suggestibility.	Baseline
Other	Baseline mindfulness	Five-Facet Mindfulness Questionnaire. This is a self-report questionnaire composed of 39 items divided in five domains (observing, describing, acting with awareness, non-judging, and non-reactivity). The items are answered in a 5-point Likert scale, from 0 ("never") to 4 ("always"). Higher scores indicate greater mindfulness capacities.	Baseline
Other	Acceptance	Acceptance and Action Questionnaire-II. The items of the 7-item AAQ-II are answered in a 7-point type of Likert scale (from 1 = "never true") to 7 ("always true") that assess a single domain of acceptance. Higher scores indicate higher degree of acceptance.	Baseline
Other	Pain-related beliefs	35-item Survey of Pain Attitudes (35-item SOPA). This is a 35-item self-report questionnaire assessing seven pain-related beliefs or domains: pain control, disability, medical cure, solicitude, medication, emotion, and harm. Participants are asked to specify their degree of agreement with each statement in a Likert scale from 0 ("This is very untrue for me") to 4 ("This is very true for me"). Seven scores (one per pain-related belief) are computed. Higher scores indicate greater agreement with each belief.	Baseline
Other	Trait spirituality	Spiritual Transcendence Scale. This is a 24-item self-report questionnaire assessing three domains: prayer fulfillment, universality and connectedness. Respondents are asked to rate their degree of agreement with each statement in a Likert scale, from 1 ("completely disagree") to 5 ("completely agree"). Higher scores indicate greater trait spirituality.	Baseline
Other	Religiosity	Duke University Religiosity Index. This is a 5 items measure that assesses three major dimensions (corresponding the scale's three domains or subscales) of religious involvement: organizational religious activity, non-organizational religious activity, and intrinsic or subjective religiosity. Two items are answered in a 6 points type of Likert scale, from 1 to 6. Three items are answered in a 5 points Likert scale, from 1 to 5. Higher scores on the three subscales and on the total score of the measure indicate higher religiosity.	Baseline
Primary	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)
Primary	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	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)
Secondary	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)