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

Not Applicable

Not yet recruiting

• Conditions: Hypnosis, Mindfulness Meditation
• Interventions: Other: Natural text audio (control audio); Other: Mindfulness meditation audio; Other: Hypnosis audio

• Registration Number: NCT06232382
• Lead Sponsor: Siriraj Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-30
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-28
• Last Update Submitted: 2024-01-28
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Study Start: 2024-02
• Primary Completion: 2024-10
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural text audio	Natural text audio (control audio)	20 minutes audio
Mindfulness meditation	Mindfulness meditation audio	20 minutes audio
Hypnosis Audio	Hypnosis audio	20 minutes audio

Primary Outcome Measures

Name	Time	Method
Change in pain intensity	Baseline (immediately prior to intervention), 5 minutes after the intervention	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."

Secondary Outcome Measures

Name	Time	Method
Change in anxiety	Baseline (immediately prior to intervention), 5 minutes after the intervention	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."
Average, worst, and least pain intensity experienced during the sessions	5 minutes after the intervention	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
Satisfaction	5 minutes after intervention	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.
Change in quality of sleep	Baseline (immediately prior to intervention) and 24 hours after session (by telephone interview)	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)