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

Siriraj Hospital

Status: Not yet enrolling

Conditions: Hypnosis, Mindfulness Meditation

Treatments: Other: Mindfulness meditation audio; Other: Hypnosis audio; Other: Natural text audio (control audio)

Study type: Interventional

Funder types: Other

Identifiers

NCT06232382

Si 912/2023

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 3 patient groups, including a placebo group

Hypnosis Audio

Experimental group

Description:

20 minutes audio

Treatment:

Other: Hypnosis audio

Mindfulness meditation

Experimental group

Description:

20 minutes audio

Treatment:

Other: Mindfulness meditation audio

Natural text audio

Placebo Comparator group

Description:

20 minutes audio

Treatment:

Other: Natural text audio (control audio)