Hypnosis, Mindfulness Meditation
Conditions
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.
Interventions
OTHERHypnosis audio
* 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.
OTHERMindfulness meditation audio
* 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.
OTHERNatural 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: 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.
Sponsors
Siriraj Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
* Participants will be blind to the study hypotheses. * To keep the experimenter blind, the participants will not reveal what they hear in the audios.
Intervention model description
1. Audio hypnosis (HYP) 2. Audio mindfulness (MM) 3. A control condition (a voice reading neutral text)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
Primary ContactSarocha Watatham, MD
Outcome results
None listed