Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Enrolling by invitation Not applicable

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.

NCT06697574 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2024-11-29
Last updated
2024-11-20

Condition(s) studied

Oral Lichen Planus

Investigational drug(s) / intervention(s)

Hypnosis aimed at stress reduction and health of the oral mucosaPsychoeducation

Hypnosis aimed at stress reduction and health of the oral mucosa: * Induction. * Hypnotic relaxation and escalating deepening of hypnotic trance. * Suggestions for healing and wellness of the oral mucosa and for balanced and optimal performance of the immune system, tailoring metaphors and images based on interview with patients. "…the interior of the mouth is soft, healthy pink, intact and whole. It functions optimally as it should - enabling joyful eating and tasting, speaking with ease for any needed expression, any function of the mouth that needs to be used can be done so easily. The immune system is very wise - it knows perfectly how to function in a balanced and harmonious way. Its wisdom enables it to act if the body needs defense and to standby and rest if it does not". * Ego strengthening. * Anchoring - using a predetermined mark selected by the patient. * Dehypnotisation.

Psychoeducation: A short explanation about the psycho-neuro-immune system and its part in oral lichen planus

Study summary

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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Under aged. * Previous negative experience with hypnosis. * Psychiatric diagnosis of schizophrenia, personality disorder, severe depression, or history of psychosis. * Substantial cognitive decline. * Low hypnotisability. * Previous oral squamous cell carcinoma.

Primary outcome measure(s)

  • Improvement in clinical expression of Oral Lichen Planus — 3 months
    The investigators expect to see an improvement in the clinical manifestation of oral lichen planus in the hypnotherapy group by assessing the score of the semiquantitive scale as described by Piboonniyom et al OOOO 2005
  • Improvement in clinical expression of Oral Lichen Planus — 3 months
    The investigators expect to see an improvement in pain or discomfort of oral lichen planus in the hypnotherapy group as stated on a 0-10 Numerical Rating Scale (NRS).
  • Improvement in clinical expression of Oral Lichen Planus — 3 months
    The investigators expect to see an improvement in the overall experience of living with oral lichen planus in the hypnotherapy group as measured buy the OHIP-14 questionnaire.

Trial sites (1)

FacilityCityRegionStatus
Oral Medicine Unit, Tel Aviv Sourasky Medical Center Tel Aviv Israel
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06697574 on ClinicalTrials.gov ↗ ← All trials in Israel