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

Siriraj Hospital165 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

165

Conditions

Interventions

Hypnosis audioOTHER

* 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 audioOTHER

* 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 (control audio)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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in pain intensity

Current pain intensity will be assessed using a 0 - 10 numerical rating scale with 0 = "No pain" and 10 = "Pain as bad as it could be."

Time frame: Baseline (immediately prior to intervention), 5 minutes after the intervention

Secondary Outcomes

Change in anxiety

Anxiety at pre- and post-session using a 0-10 numerical rating scale with 0 = "No anxiety" and 10 = "Anxiety as bad as it could be."

Time frame: Baseline (immediately prior to intervention), 5 minutes after the intervention

Average, worst, and least pain intensity experienced during the sessions

0-10 numerical rating scale with 0 = "No pain" and 10 = "Pain as bad as it could be." assessing average, worst, and least pain intensity experienced during the sessions

Time frame: 5 minutes after the intervention

Satisfaction

1-5 categorical scale of treatment satisfaction assessed at post-treatment \- "Not at all Satisfied," "Partly Satisfied," "Satisfied," "More than Satisfied," "Very Satisfied," numbering 1 to 5 as an interval scale.

Time frame: 5 minutes after intervention

Change in quality of sleep

Quality of sleep using the Thai version of the Patient-Reported Outcomes Measurement Information System-29 (T-PROMIS-29) sleep disturbance section (4 items) \- Minimum score = 4, Maximum score = 20 (higher scores mean a worse outcome)

Time frame: Baseline (immediately prior to intervention) and 24 hours after session (by telephone interview)