COping With PAin Through Hypnosis, Mindfulness and Spirituality (COPAHS)

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

Status: Unknown

Conditions: Pain, Acute

Treatments: Behavioral: Self-Hypnosis (SH); Behavioral: Mindfulness Meditation (MM); Behavioral: Christian Prayer (CP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04491630

ISPA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 4 patient groups

Self-Hypnosis (SH)

Active Comparator group

Treatment:

Behavioral: Self-Hypnosis (SH)

Mindfulness meditation (MM)

Active Comparator group

Treatment:

Behavioral: Mindfulness Meditation (MM)

Christian prayer (CP)

Active Comparator group

Treatment:

Behavioral: Christian Prayer (CP)

Control condition (CN)

No Intervention group

Description:

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.