Clinical trial NCT06232382: A Comparison of Hypnosis and Mindfulness on Reducing Pain in Chronic Pain Patients
Official title: A Comparison of Hypnosis and Mindfulness on Reducing Pain in Chronic Pain Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypnosis, Mindfulness Meditation
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Audio hypnosis (HYP)
2. Audio mindfulness (MM)
3. A control condition (a voice reading neutral text)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in pain intensity
timeFrame: Baseline (immediately prior to intervention), 5 minutes after the intervention
Secondary outcomes:
measure: Change in anxiety
timeFrame: Baseline (immediately prior to intervention), 5 minutes after the intervention
measure: Average, worst, and least pain intensity experienced during the sessions
timeFrame: 5 minutes after the intervention
measure: Satisfaction
timeFrame: 5 minutes after intervention
measure: Change in quality of sleep
timeFrame: Baseline (immediately prior to intervention) and 24 hours after session (by telephone interview)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.