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

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 Overview

• Status: Not yet recruiting
• Conditions: Hypnosis, Mindfulness Meditation
• Intervention / Treatment: Other: Hypnosis audio; Other: Mindfulness meditation audio; Other: Natural text audio (control audio)

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarocha Watatham, MD; Phone Number: 0844416848; Email: sarocha_new7@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis Audio; 20 minutes audio	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:Audio hypnosis (HYP)Audio mindfulness (MM)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.
Experimental: Mindfulness meditation; 20 minutes audio	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:Audio hypnosis (HYP)Audio mindfulness (MM)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.
Placebo Comparator: Natural text audio; 20 minutes audio	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:Audio hypnosis (HYP)Audio mindfulness (MM)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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	Baseline (immediately prior to intervention), 5 minutes after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	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	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.	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)	Baseline (immediately prior to intervention) and 24 hours after session (by telephone interview)

Collaborators and Investigators

• Sponsor: Siriraj Hospital

Publications and helpful links

General Publications

• Hilton L, Hempel S, Ewing BA, Apaydin E, Xenakis L, Newberry S, Colaiaco B, Maher AR, Shanman RM, Sorbero ME, Maglione MA. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis. Ann Behav Med. 2017 Apr;51(2):199-213. doi: 10.1007/s12160-016-9844-2.
• Adachi T, Fujino H, Nakae A, Mashimo T, Sasaki J. A meta-analysis of hypnosis for chronic pain problems: a comparison between hypnosis, standard care, and other psychological interventions. Int J Clin Exp Hypn. 2014;62(1):1-28. doi: 10.1080/00207144.2013.841471.
• Thuma K, Ditsataporncharoen T, Arunpongpaisal S, Siripul P. Hypnosis as an Adjunct for Managing Pain in Head and Neck Cancer Patients Post Radiotherapy. J Med Assoc Thai. 2016 Aug;99 Suppl 5:S141-7.
• Jensen MP, Sherlin LH, Askew RL, Fregni F, Witkop G, Gianas A, Howe JD, Hakimian S. Effects of non-pharmacological pain treatments on brain states. Clin Neurophysiol. 2013 Oct;124(10):2016-24. doi: 10.1016/j.clinph.2013.04.009. Epub 2013 May 22.
• Cimmino MA, Ferrone C, Cutolo M. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):173-83. doi: 10.1016/j.berh.2010.01.012.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Si 912/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No