A Comparison of Hypnosis and Mindfulness on Reducing Pain in Chronic Pain Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-03-31

Brief Summary

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The goal of this randomized controlled study is to evaluate the efficacy of an audio session of hypnosis and mindfulness meditation for providing immediate pain relief in individuals with chronic pain from Thailand. The main question\[s\] it aims to answer are:

• What effects do hypnosis and mindfulness meditation on reducing pain in chronic pain patients? Participants will

* Be randomly assigned to one of the three conditions in 20 minutes: Audio hypnosis, Audio mindfulness, A control condition
* Be blind to the study hypotheses.
* To keep the experimenter blind, the participants will not reveal what they hear in the audio.
* Pain intensity will be assessed both at pre- and post-session.
* Secondary outcomes will be assessed at pre- and post-session by the questionnaires.
* Post-session quality of sleep will be assessed by telephone interview 1 day after the session.

Primary outcome: Current pain intensity (using a 0 - 10 numerical rating scale) Secondary outcome

* Anxiety at pre and post-session using a 0-10 numerical rating scale
* 0-10 numerical rating scale assessing average, worst, and least pain intensity experienced during the sessions
* 1-5 categorical scale of treatment satisfaction assessed at post-treatment
* Quality of sleep using the Thai version of the Patient-Reported Outcomes Measurement Information System-29 (T-PROMIS-29) sleep disturbance section (4 items) at pre-session and 1 day after a session (by telephone interview)
* Duration of benefit The proposed measures of these variables have all been used successfully in prior clinical trials in samples of individuals with pain from Thailand.

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Detailed Description

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Conditions

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Hypnosis, Mindfulness Meditation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. Audio hypnosis (HYP)
2. Audio mindfulness (MM)
3. A control condition (a voice reading neutral text)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

* Participants will be blind to the study hypotheses.
* To keep the experimenter blind, the participants will not reveal what they hear in the audios.

Study Groups

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Hypnosis Audio

20 minutes audio

Group Type EXPERIMENTAL

Hypnosis audio

Intervention Type OTHER

* After informed consent was obtained and baseline assessment, patients will be randomly assigned to one of the three conditions in 20 minutes:

1. Audio hypnosis (HYP)
2. Audio mindfulness (MM)
3. A control condition (a voice reading neutral text) These audios will be produced together with hypnotherapist in Thailand, psychiatrist and researchers.
* The randomization process will be performed using a computerized random sequence generator.
* The patient listens to "Hypnosis" audio recording through headphones in a private room.
* Participants will be blind to the study hypotheses.
* To keep the experimenter blind, the participants will not reveal what they hear in the audios.
* Pain intensity will be assessed both at pre- and post-session (5 minutes).
* Secondary outcomes will be assessed at pre- and post-session by the questionnaires (5 minutes).
* Post-session quality of sleep will be assessed by telephone interview 1 day after session.

Mindfulness meditation

20 minutes audio

Group Type EXPERIMENTAL

Mindfulness meditation audio

Intervention Type OTHER

* After informed consent was obtained and baseline assessment, patients will be randomly assigned to one of the three conditions in 20 minutes:

1. Audio hypnosis (HYP)
2. Audio mindfulness (MM)
3. A control condition (a voice reading neutral text) These audios will be produced together with hypnotherapist in Thailand, psychiatrist and researchers.
* The randomization process will be performed using a computerized random sequence generator.
* The patient listens to "Mindfulness Meditation" audio recording through headphones in a private room.
* Participants will be blind to the study hypotheses.
* To keep the experimenter blind, the participants will not reveal what they hear in the audios.
* Pain intensity will be assessed both at pre- and post-session. (5 minutes)
* Secondary outcomes will be assessed at pre- and post-session by the questionnaires. (5 minutes)
* Post-session quality of sleep will be assessed by telephone interview 1 day after session.

Natural text audio

20 minutes audio

Group Type PLACEBO_COMPARATOR

Natural text audio (control audio)

Intervention Type OTHER

* After informed consent was obtained and baseline assessment, patients will be randomly assigned to one of the three conditions in 20 minutes:

1. Audio hypnosis (HYP)
2. Audio mindfulness (MM)
3. A control condition (a voice reading neutral text) These audios will be produced together with hypnotherapist in Thailand, psychiatrist and researchers.
* The randomization process will be performed using a computerized random sequence generator.
* The patient listens to "Control" audio recording through headphones in a private room.
* Participants will be blind to the study hypotheses.
* To keep the experimenter blind, the participants will not reveal what they hear in the audios.
* Pain intensity will be assessed both at pre- and post-session. (5 minutes)
* Secondary outcomes will be assessed at pre- and post-session by the questionnaires. (5 minutes)
* Post-session quality of sleep will be assessed by telephone interview 1 day after session.

Interventions

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Hypnosis audio

* After informed consent was obtained and baseline assessment, patients will be randomly assigned to one of the three conditions in 20 minutes:

1. Audio hypnosis (HYP)
2. Audio mindfulness (MM)
3. A control condition (a voice reading neutral text) These audios will be produced together with hypnotherapist in Thailand, psychiatrist and researchers.
* The randomization process will be performed using a computerized random sequence generator.
* The patient listens to "Hypnosis" audio recording through headphones in a private room.
* Participants will be blind to the study hypotheses.
* To keep the experimenter blind, the participants will not reveal what they hear in the audios.
* Pain intensity will be assessed both at pre- and post-session (5 minutes).
* Secondary outcomes will be assessed at pre- and post-session by the questionnaires (5 minutes).
* Post-session quality of sleep will be assessed by telephone interview 1 day after session.

Intervention Type OTHER

Mindfulness meditation audio

* After informed consent was obtained and baseline assessment, patients will be randomly assigned to one of the three conditions in 20 minutes:

1. Audio hypnosis (HYP)
2. Audio mindfulness (MM)
3. A control condition (a voice reading neutral text) These audios will be produced together with hypnotherapist in Thailand, psychiatrist and researchers.
* The randomization process will be performed using a computerized random sequence generator.
* The patient listens to "Mindfulness Meditation" audio recording through headphones in a private room.
* Participants will be blind to the study hypotheses.
* To keep the experimenter blind, the participants will not reveal what they hear in the audios.
* Pain intensity will be assessed both at pre- and post-session. (5 minutes)
* Secondary outcomes will be assessed at pre- and post-session by the questionnaires. (5 minutes)
* Post-session quality of sleep will be assessed by telephone interview 1 day after session.

Intervention Type OTHER

Natural text audio (control audio)

* After informed consent was obtained and baseline assessment, patients will be randomly assigned to one of the three conditions in 20 minutes:

1. Audio hypnosis (HYP)
2. Audio mindfulness (MM)
3. A control condition (a voice reading neutral text) These audios will be produced together with hypnotherapist in Thailand, psychiatrist and researchers.
* The randomization process will be performed using a computerized random sequence generator.
* The patient listens to "Control" audio recording through headphones in a private room.
* Participants will be blind to the study hypotheses.
* To keep the experimenter blind, the participants will not reveal what they hear in the audios.
* Pain intensity will be assessed both at pre- and post-session. (5 minutes)
* Secondary outcomes will be assessed at pre- and post-session by the questionnaires. (5 minutes)
* Post-session quality of sleep will be assessed by telephone interview 1 day after session.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Being ≥ 18 years old
2. Having chronic, non cancer pain (i.e., reporting bothersome pain for at least 50% of the days during the last three months)
3. Nociceptive, neuropathic, nociplastic pain characteristic
4. Endorsing having current pain intensity of ≥ 4 on a 0 to 10 Numerical Rating Scale
5. Being able to read, speak, and understand Thai

Exclusion Criteria

1. Having significant hearing loss that would interfere with being able to hear the study audio
2. Having significant cognitive dysfunction, physical disability, or severe mood disturbance (e.g., significant anger or high lability) that would interfere with being able to participate in the study procedures
3. Cancer-related pain or cancer patients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No