NCT06232382

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

A Comparison of Hypnosis and Mindfulness on Reducing Pain in Chronic Pain Patients: A Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Siriraj Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypnosis, Mindfulness Meditation

Interventions

Type	Name	Description
OTHER	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.
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.
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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-10-01
• Completion: 2025-03-01
• First posted: 2024-01-30
• Last updated: 2024-01-30