Hypnosis, Mindfulness MeditationNCT06232382
A Comparison of Hypnosis and Mindfulness on Reducing Pain in Chronic Pain Patients
A study testing Hypnosis audio and Mindfulness meditation audio in people with Hypnosis, Mindfulness Meditation, run by Siriraj Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypnosis, Mindfulness Meditation
- What is being tested?
- Hypnosis audio and Mindfulness meditation audio
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being ≥ 18 years old
- Having chronic, non cancer pain (i.e., reporting bothersome pain for at least 50% of the days during the last three months)
- Nociceptive, neuropathic, nociplastic pain characteristic
- Endorsing having current pain intensity of ≥ 4 on a 0 to 10 Numerical Rating Scale
- Being able to read, speak, and understand Thai
Who cannot join
- Having significant hearing loss that would interfere with being able to hear the study audio
- 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
- Cancer-related pain or cancer patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Conditions
- Hypnosis, Mindfulness Meditation
- Being tested
- Hypnosis audio, Mindfulness meditation audio, Natural text audio (control audio)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis audioOther
- 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.
Mindfulness meditation audioOther
- 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.
Natural text audio (control audio)Other
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis Audio | Experimental | 20 minutes audio Receives: Other: Hypnosis audio |
| Mindfulness meditation | Experimental | 20 minutes audio Receives: Other: Mindfulness meditation audio |
| Natural text audio | Placebo comparator | 20 minutes audio Receives: Other: Natural text audio (control audio) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline (immediately prior to intervention), 5 minutes after the intervention
Secondary outcomes (4)
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."
Measured: 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
Measured: 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.
Measured: 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)
Measured: Baseline (immediately prior to intervention) and 24 hours after session (by telephone interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypnosis, Mindfulness MeditationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Audio hypnosis (HYP) 2. Audio mindfulness (MM) 3. A control condition (a voice reading neutral text)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarocha Watatham, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232382
- Sponsor's protocol ID
- Si 912/2023
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24256477Hilton 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.
PubMed 27658913Thuma 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.
PubMed 29906024Jensen 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.
PubMed 23706958Cimmino 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.
PubMed 22094194
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Hypnosis and Mindfulness on Reducing Pain in Chronic Pain Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06232382
- Acronym / sponsor ID
- Si 912/2023
- Conditions
- Hypnosis, Mindfulness Meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. Audio hypnosis (HYP) 2. Audio mindfulness (MM) 3. A control condition (a voice reading neutral text)
| Arm | Type | Receives |
|---|---|---|
| Hypnosis Audio | Experimental | Other: Hypnosis audio20 minutes audio |
| Mindfulness meditation | Experimental | Other: Mindfulness meditation audio20 minutes audio |
| Natural text audio | Placebo comparator | Other: Natural text audio (control audio)20 minutes audio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being ≥ 18 years old
- Having chronic, non cancer pain (i.e., reporting bothersome pain for at least 50% of the days during the last three months)
- Nociceptive, neuropathic, nociplastic pain characteristic
- Endorsing having current pain intensity of ≥ 4 on a 0 to 10 Numerical Rating Scale
- Being able to read, speak, and understand Thai
Key exclusion criteria (3 listed)
- Having significant hearing loss that would interfere with being able to hear the study audio
- 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
- Cancer-related pain or cancer patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis 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. | Other | Hypnosis Audio |
| 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: 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. | Other | Mindfulness meditation |
| 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: 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. | Other | Natural text audio |
Primary outcome
Change in pain intensity
Time frame: 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."
4 secondary outcomes
Change in anxiety
Time frame: Baseline (immediately prior to intervention), 5 minutes after the intervention
Average, worst, and least pain intensity experienced during the sessions
Time frame: 5 minutes after the intervention
Satisfaction
Time frame: 5 minutes after intervention
Change in quality of sleep
Time frame: Baseline (immediately prior to intervention) and 24 hours after session (by telephone interview)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 24256477Adachi 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.
- Background: PubMed 27658913Hilton 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.
- Background: PubMed 29906024Thuma 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.
- Background: PubMed 23706958Jensen 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.
- Results publication: PubMed 22094194Cimmino 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.
- Individual participant dataSharing planned: No
Related trials for Hypnosis, Mindfulness Meditation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis audio and Mindfulness meditation audio in people with Hypnosis, Mindfulness Meditation, run by Siriraj Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarocha Watatham, MD (0844416848, sarocha_new7@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Baseline (immediately prior to intervention), 5 minutes after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232382, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.