HypnoPain Relief for OA

NCT07850271 | Active Not Recruiting

• 1 other identifier: UGM-PSI-HYPNOPAINRELIEF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoarthritis (OA)

Keywords

Osteoarthritis; Chronic pain; Clinical hypnosis; Hypnosis; Pain management; Quality of life; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  : 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

  Baseline to posttest (after completion of Session 2; approximately 1-2 weeks), and 2 week follow up.

Other Outcomes (2)

• Change in Resting State Psychophysiological Measures Following Clinical Hypnosis Intervention

  EEG frequency band power (µV²) and HRV parameters (e.g., RMSSD in milliseconds)

• Participant Experiences and Acceptability of the Clinical Hypnosis Intervention

  Four week follow up after completion of the intervention

Study Arms (2)

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.

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.

Other: Neutral Visual Exposure Waitlist Control

Interventions

HypnoPain Relief (HPR) BEHAVIORAL

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.

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.

Neutral Visual Exposure Waitlist Control

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Faculty of Psychology

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Osteoarthritis; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to the specific intervention condition assigned to them. The intervention provider cannot be blinded due to differences in the procedures delivered between the clinical hypnosis intervention and the control condition. Outcome assessors responsible for administering and scoring self report measures are blinded to participant allocation. The qualitative interview coding process is conducted by assessors independent of intervention delivery and blinded to allocation status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 30, 2026
• Study Start: May 1, 2026
• Primary Completion: August 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)