Osteoarthritis (OA)HPRNCT07850271
HypnoPain Relief for OA
A study testing HypnoPain Relief (HPR) in people with Osteoarthritis (OA), run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn whether HypnoPain Relief (HPR), a brief clinical hypnosis intervention, can help reduce pain and improve quality of life in adults with osteoarthritis. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis (OA)
- What is being tested?
- HypnoPain Relief (HPR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years.
- Diagnosis of osteoarthritis confirmed through clinical examination or radiological assessment by a medical professional.
- Chronic pain associated with osteoarthritis with a minimum duration of three months.
- Pain intensity related to osteoarthritis assessed using the Numeric Rating Scale (NRS).
- Able to read and understand Indonesian.
- Not currently receiving regular psychological therapy.
- Willing and able to participate in all study procedures.
- Provide written informed consent before participation.
Who cannot join
- Diagnosis of severe psychiatric disorders, including schizophrenia, bipolar disorder, or major depressive disorder with current suicide risk.
- Diagnosis of neurological disorders associated with seizure risk, such as epilepsy.
- Current regular use of medications with significant central sedative effects, including benzodiazepines, opioid analgesics at sedating doses, or sedating antihistamines.
- Current participation in hypnosis or other similar nonpharmacological psychological interventions during the study period.
- Hearing impairment or communication difficulties that prevent understanding of study procedures or completing questionnaires.
- Serious concurrent medical conditions that may interfere with participation, such as advanced cancer or severe cardiovascular disease.
- Inability or unwillingness to complete the intervention sessions and follow up assessments.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Psychology
Yogyakarta, Special Region of Yogyakarta, 55281
About this study
Official title: Clinical Hypnosis for Pain and Quality of Life in Adults With Osteoarthritis: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether HypnoPain Relief (HPR), a brief clinical hypnosis intervention, can help reduce pain and improve quality of life in adults with osteoarthritis. The main questions it aims to answer are:
Does HypnoPain Relief reduce pain intensity in adults with osteoarthritis? Does HypnoPain Relief improve osteoarthritis related functioning and quality of life?
Read more
Researchers will compare participants receiving the HypnoPain Relief intervention with participants receiving a neutral visual exposure condition to see whether the clinical hypnosis intervention improves pain and quality of life outcomes.
Participants will:
Complete questionnaires about pain, physical functioning, quality of life, emotional symptoms, and psychological well being before and after the intervention and during follow up assessments.
Receive either two individual sessions of HypnoPain Relief or two sessions of neutral visual exposure.
Complete follow up assessments after the intervention to evaluate changes over time.
Participate in physiological measurements during intervention sessions, including brain activity, heart rate variability, skin response, and body temperature measurements.
Read the detailed description
Detailed Description
Osteoarthritis is a chronic musculoskeletal condition commonly associated with persistent pain, functional limitations, and reduced quality of life. Although pharmacological and nonpharmacological treatments are available, some individuals continue to experience clinically significant pain and impairment. This study evaluates HypnoPain Relief (HPR), a brief clinical hypnosis intervention developed as a supportive approach for osteoarthritis pain management.
This study is a randomized controlled trial evaluating the effects of a two session individual clinical hypnosis intervention compared with a neutral visual exposure control condition among adults with osteoarthritis. The study aims to examine whether HPR contributes to improvements in pain related outcomes and osteoarthritis specific quality of life.
HypnoPain Relief is a structured clinical hypnosis intervention based on established clinical hypnosis principles. The intervention includes therapeutic preparation, hypnotic induction, deepening procedures, therapeutic suggestions targeting pain modulation, and psychological strengthening strategies. The intervention is delivered individually by a trained clinical psychologist following a standardized treatment manual.
The study also explores physiological responses associated with clinical hypnosis procedures. Psychophysiological assessments are included to characterize changes occurring during hypnosis sessions and to provide preliminary information regarding potential mechanisms associated with intervention response.
Intervention delivery is monitored using treatment fidelity assessment to evaluate adherence to the standardized HPR protocol. Participant experiences following the intervention are explored to provide additional information regarding acceptability and perceived changes related to the intervention.
The findings from this trial are expected to provide preliminary evidence regarding the potential application of brief clinical hypnosis for adults with osteoarthritis and inform future clinical trials investigating hypnosis based interventions for chronic pain management.
- Conditions
- Osteoarthritis (OA)
- Being tested
- HypnoPain Relief (HPR), Neutral Visual Exposure Waitlist Control
- Keywords
- Osteoarthritis, Chronic pain, Clinical hypnosis, Hypnosis, Pain management, Quality of life, Randomized controlled trial
- Medical subject headings
- Osteoarthritis, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoPain Relief (HPR)Behavioural
HypnoPain Relief (HPR) is a structured individual clinical hypnosis intervention developed for adults with osteoarthritis related pain. The intervention consists of two sessions delivered by a trained therapist. Each session includes therapeutic preparation, hypnotic induction and deepening, therapeutic suggestions targeting pain modulation, and ego strengthening with post hypnotic suggestion. The intervention follows a standardized treatment manual based on established clinical hypnosis principles.
Neutral Visual Exposure Waitlist ControlOther
Participants assigned to this arm receive two brief neutral visual exposure sessions during the waiting period. During each session, participants view standardized neutral images for approximately 15 minutes without clinical hypnosis procedures or therapeutic intervention. Participants complete outcome assessments before and after the control period. After completion of the posttest assessment, participants are offered one session of HypnoPain Relief as a delayed intervention opportunity.
| Study group | Role | What they receive |
|---|---|---|
| HypnoPain Relief (HPR) | Experimental | HypnoPain Relief (HPR) is a structured individual clinical hypnosis intervention developed for adults with osteoarthritis related pain. The intervention consists of two sessions delivered by a trained therapist. Each session includes therapeutic preparation, hypnotic induction and deepening, therapeutic suggestions targeting pain modulation, and ego strengthening with post hypnotic suggestion. The intervention follows a standardized treatment manual based on established clinical hypnosis principles. Receives: Behavioral: HypnoPain Relief (HPR) |
| Neutral Visual Exposure Waitlist Control | Other | Participants assigned to this arm receive two brief neutral visual exposure sessions during the waiting period. During each session, participants view standardized neutral images for approximately 15 minutes without clinical hypnosis procedures or therapeutic intervention. Participants complete outcome assessments before and after the control period. After completion of the posttest assessment, participants are offered one session of HypnoPain Relief as a delayed intervention opportunity. Receives: Other: Neutral Visual Exposure Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Rating Scale Pain Intensity Score
Pain intensity will be assessed using the 11 point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). The primary outcome will be the change in pain intensity score from baseline to posttest following completion of the HypnoPain Relief intervention compared with the control condition.
Unit of Measure: NRS score (0-10).
Measured: Baseline to posttest (after completion of Session 2; approximately 1-2 weeks), and 2 week follow up.
Change in Total WOMAC Score
Osteoarthritis related symptoms and functional impairment will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total WOMAC score represents overall osteoarthritis related pain, stiffness, and physical functioning, with higher scores indicating greater symptom severity and functional limitation.
Unit of Measure: WOMAC total score.
Measured: : Baseline to posttest (after completion of Session 2; approximately 1-2 weeks) and 2 week follow up.
Secondary outcomes (1)
Change in HADS Anxiety and Depression Subscale Score
Anxiety symptoms will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS A). Higher scores indicate greater anxiety symptom severity. Depressive symptoms will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS D). Higher scores indicate greater depressive symptom severity.
Measured: Baseline to posttest (after completion of Session 2; approximately 1-2 weeks), and 2 week follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 May 2026
- Primary completion30 Aug 2026
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA)Studies 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
- This is a two arm, parallel group randomized controlled trial comparing a clinical hypnosis intervention (HypnoPain Relief) with an attention matched waitlist control condition. Participants are randomly assigned to either the intervention group or control group and are assessed at baseline, after completion of the intervention, and during follow up assessments.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siti Makhmudah, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850271
- Sponsor's protocol ID
- UGM-PSI-HYPNOPAINRELIEF
- Acronym
- HPR
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be shared upon reasonable request after study completion and publication, subject to ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Hypnosis for Pain and Quality of Life in Adults With Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07850271
- Acronym / sponsor ID
- HPR / UGM-PSI-HYPNOPAINRELIEF
- Conditions
- Osteoarthritis (OA)
- Keywords
- Osteoarthritis, Chronic pain, Clinical hypnosis, Hypnosis, Pain management, Quality of life, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 30 Sep 2026 (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 clinical trial is to learn whether HypnoPain Relief (HPR), a brief clinical hypnosis intervention, can help reduce pain and improve quality of life in adults with osteoarthritis. The main questions it aims to answer are:
Does HypnoPain Relief reduce pain intensity in adults with osteoarthritis? Does HypnoPain Relief improve osteoarthritis related functioning and quality of life?
Researchers will compare participants receiving the HypnoPain Relief intervention with participants receiving a neutral visual exposure condition to see whether the clinical hypnosis intervention improves pain and quality of life outcomes.
Participants will:
Complete questionnaires about pain, physical functioning, quality of life, emotional symptoms, and psychological well being before and after the intervention and during follow up assessments.
Receive either two individual sessions of HypnoPain Relief or two sessions of neutral visual exposure.
Complete follow up assessments after the intervention to evaluate changes over time.
Participate in physiological measurements during intervention sessions, including brain activity, heart rate variability, skin response, and body temperature measurements.
Detailed description
Detailed Description
Osteoarthritis is a chronic musculoskeletal condition commonly associated with persistent pain, functional limitations, and reduced quality of life. Although pharmacological and nonpharmacological treatments are available, some individuals continue to experience clinically significant pain and impairment. This study evaluates HypnoPain Relief (HPR), a brief clinical hypnosis intervention developed as a supportive approach for osteoarthritis pain management.
This study is a randomized controlled trial evaluating the effects of a two session individual clinical hypnosis intervention compared with a neutral visual exposure control condition among adults with osteoarthritis. The study aims to examine whether HPR contributes to improvements in pain related outcomes and osteoarthritis specific quality of life.
HypnoPain Relief is a structured clinical hypnosis intervention based on established clinical hypnosis principles. The intervention includes therapeutic preparation, hypnotic induction, deepening procedures, therapeutic suggestions targeting pain modulation, and psychological strengthening strategies. The intervention is delivered individually by a trained clinical psychologist following a standardized treatment manual.
The study also explores physiological responses associated with clinical hypnosis procedures. Psychophysiological assessments are included to characterize changes occurring during hypnosis sessions and to provide preliminary information regarding potential mechanisms associated with intervention response.
Intervention delivery is monitored using treatment fidelity assessment to evaluate adherence to the standardized HPR protocol. Participant experiences following the intervention are explored to provide additional information regarding acceptability and perceived changes related to the intervention.
The findings from this trial are expected to provide preliminary evidence regarding the potential application of brief clinical hypnosis for adults with osteoarthritis and inform future clinical trials investigating hypnosis based interventions for chronic pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two arm, parallel group randomized controlled trial comparing a clinical hypnosis intervention (HypnoPain Relief) with an attention matched waitlist control condition. Participants are randomly assigned to either the intervention group or control group and are assessed at baseline, after completion of the intervention, and during follow up assessments.
| Arm | Type | Receives |
|---|---|---|
| HypnoPain Relief (HPR) | Experimental | Behavioral: HypnoPain Relief (HPR)HypnoPain Relief (HPR) is a structured individual clinical hypnosis intervention developed for adults with osteoarthritis related pain. The intervention consists of two sessions delivered by a trained therapist. Each session includes therapeutic preparation, hypnotic induction and deepening, therapeutic suggestions targeting pain modulation, and ego strengthening with post hypnotic suggestion. The intervention follows a standardized treatment manual based on established clinical hypnosis principles. |
| Neutral Visual Exposure Waitlist Control | Other | Other: Neutral Visual Exposure Waitlist ControlParticipants assigned to this arm receive two brief neutral visual exposure sessions during the waiting period. During each session, participants view standardized neutral images for approximately 15 minutes without clinical hypnosis procedures or therapeutic intervention. Participants complete outcome assessments before and after the control period. After completion of the posttest assessment, participants are offered one session of HypnoPain Relief as a delayed intervention opportunity. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 to 80 years.
- Diagnosis of osteoarthritis confirmed through clinical examination or radiological assessment by a medical professional.
- Chronic pain associated with osteoarthritis with a minimum duration of three months.
- Pain intensity related to osteoarthritis assessed using the Numeric Rating Scale (NRS).
- Able to read and understand Indonesian.
Key exclusion criteria (7 listed)
- Diagnosis of severe psychiatric disorders, including schizophrenia, bipolar disorder, or major depressive disorder with current suicide risk.
- Diagnosis of neurological disorders associated with seizure risk, such as epilepsy.
- Current regular use of medications with significant central sedative effects, including benzodiazepines, opioid analgesics at sedating doses, or sedating antihistamines.
- Current participation in hypnosis or other similar nonpharmacological psychological interventions during the study period.
- Hearing impairment or communication difficulties that prevent understanding of study procedures or completing questionnaires.
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 |
|---|---|---|
| HypnoPain Relief (HPR)HypnoPain Relief (HPR) is a structured individual clinical hypnosis intervention developed for adults with osteoarthritis related pain. The intervention consists of two sessions delivered by a trained therapist. Each session includes therapeutic preparation, hypnotic induction and deepening, therapeutic suggestions targeting pain modulation, and ego strengthening with post hypnotic suggestion. The intervention follows a standardized treatment manual based on established clinical hypnosis principles. | Behavioural | HypnoPain Relief (HPR) |
| Neutral Visual Exposure Waitlist ControlParticipants assigned to this arm receive two brief neutral visual exposure sessions during the waiting period. During each session, participants view standardized neutral images for approximately 15 minutes without clinical hypnosis procedures or therapeutic intervention. Participants complete outcome assessments before and after the control period. After completion of the posttest assessment, participants are offered one session of HypnoPain Relief as a delayed intervention opportunity. | Other | Neutral Visual Exposure Waitlist Control |
Primary outcome
Change in Numeric Rating Scale Pain Intensity Score
Time frame: Baseline to posttest (after completion of Session 2; approximately 1-2 weeks), and 2 week follow up.
Pain intensity will be assessed using the 11 point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). The primary outcome will be the change in pain intensity score from baseline to posttest following completion of the HypnoPain Relief intervention compared with the control condition. Unit of Measure: NRS score (0-10).
Change in Total WOMAC Score
Time frame: : Baseline to posttest (after completion of Session 2; approximately 1-2 weeks) and 2 week follow up.
Osteoarthritis related symptoms and functional impairment will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total WOMAC score represents overall osteoarthritis related pain, stiffness, and physical functioning, with higher scores indicating greater symptom severity and functional limitation. Unit of Measure: WOMAC total score.
1 secondary outcome
Change in HADS Anxiety and Depression Subscale Score
Time frame: Baseline to posttest (after completion of Session 2; approximately 1-2 weeks), and 2 week follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. De-identified data may be shared upon reasonable request after study completion and publication, subject to ethics approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HypnoPain Relief (HPR) in people with Osteoarthritis (OA), run by Gadjah Mada University at 1 site in Indonesia.
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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Rating Scale Pain Intensity Score (time frame: Baseline to posttest (after completion of Session 2; approximately 1-2 weeks), and 2 week follow up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.