Hypnotherapy for Oral Lichen Planus. Patients with Clinically and Histologically Confirmed Oral Lichen Planus Would Be Randomized for Hypnotherapy Vs Psychoeducation About the Pyschoneuroimmune System. Follow Up Would Be Done At 2, 6, 12 Weeks After.
Key facts
- Who runs it
- Tel-Aviv Sourasky Medical Center
- Where
- Israel1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 60 people, planned
- Started
- 29 Nov 2024
- Expected to end
- 29 Nov 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Hypnosis aimed at stress reduction and health of the oral mucosa
- Psychoeducation
- Record updated
- 20 November 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Histopathologically and clinically confirmed diagnosis of OLP
- At least 1 year since diagnosis
- Above 18 years of age
- Fluent in Hebrew or English (for the purpose of hypnosis)
- Lesions that are consistent with OLP are clinically visible in oral cavity
Who cannot take part
- Previous negative experience with hypnosis
- Previous oral squamous cell carcinoma
- Psychiatric diagnosis of schizophrenia, personality disorder, severe depression, or history of psychosis
- Under aged
- Substantial cognitive decline
- Low hypnotisability
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
60 patients with clinically and histologically confirmed Oral Lichen Planus, which are are typically followed up at our oral mucosal disease clinic with a standing diagnosis for at least 1 year would be randomized.
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30 would undergo a session of psychoeducation and hyponotherapy and 30 would undergo psychoeducation alone. This would be done by the PI who is an oral medicine specialist and licensed for medical hypnosis.
Patients would be instructed to practice self hypnosis and would be followed up by their original oral medicine specialists who would be blinded to the intervention the had recieved - follow up would be done at 2, 6, and 12 week intervals.
Patients would be asked to fill 3 standardized questionnaires (translated to Hebrew and verified): PHQ-9, OHIP-14, ERQ . The clinical appearance of their lichen planus would be documented using a standardized semi-quantitive method as described by Piboonniyom et al, OOOO 2005
The 3 groups in the trial
- Psychoeducation and Hypnotherapy GroupTreatment being tested
30 Patients randomized to undergo psychoeducation and hypnotherapy
Treatment: Hypnosis aimed at stress reduction and health of the oral mucosa and Psychoeducation
- Psychoeducation GroupExisting treatment, for comparison
30 Patients selected for psychoeducation with out hypnotherapy
Treatment: Psychoeducation
- Non intervention group - retrospectively analyzedNo study treatment, for comparison
30 age matched patients from the oral mucosal clinic who's course and presentation of lichen planus would be retrospectively analyzed
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- HypnOLP Trial Hypnotherapy for Oral Lichen Planus - a Single Blind Randomized Controlled Trial
- Record updated
- 20 November 2024