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 | Enrolling By Invitation

• 1 other identifier: TASMC-24-GW-0299-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oral Lichen Planus

Keywords

Oral Lichen Planus; Hypnosis

Outcome Measures

Primary Outcomes (3)

• Improvement in clinical expression of Oral Lichen Planus

  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

  3 months

• Improvement in clinical expression of Oral Lichen Planus

  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).

  3 months

• Improvement in clinical expression of Oral Lichen Planus

  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.

  3 months

Secondary Outcomes (2)

• Stress reduction and overall improvement in quality of life

  3 months

• Stress reduction and overall improvement in quality of life

  3 months

Study Arms (3)

Psychoeducation and Hypnotherapy Group

EXPERIMENTAL

30 Patients randomized to undergo psychoeducation and hypnotherapy

Behavioral: Hypnosis aimed at stress reduction and health of the oral mucosa; Behavioral: Psychoeducation

Psychoeducation Group

ACTIVE COMPARATOR

30 Patients selected for psychoeducation with out hypnotherapy

Behavioral: Psychoeducation

Non intervention group - retrospectively analyzed

NO INTERVENTION

30 age matched patients from the oral mucosal clinic who's course and presentation of lichen planus would be retrospectively analyzed

Interventions

Hypnosis aimed at stress reduction and health of the oral mucosa BEHAVIORAL

* 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 and Hypnotherapy Group

Psychoeducation BEHAVIORAL

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

Psychoeducation Group; Psychoeducation and Hypnotherapy Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Oral Medicine Unit, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (14)

• Piboonniyom SO, Treister N, Pitiphat W, Woo SB. Scoring system for monitoring oral lichenoid lesions: a preliminary study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Jun;99(6):696-703. doi: 10.1016/j.tripleo.2004.07.013.

  PMID: 15897856 BACKGROUND

• Shenefelt PD. Hypnosis in dermatology. Arch Dermatol. 2000 Mar;136(3):393-9. doi: 10.1001/archderm.136.3.393.

  PMID: 10724204 BACKGROUND

• Day M, Clarke SA, Castillo-Eito L, Rowe R. Psychoeducation for Children with Chronic Conditions: A Systematic Review and Meta-analysis. J Pediatr Psychol. 2020 May 1;45(4):386-398. doi: 10.1093/jpepsy/jsaa015.

  PMID: 32219409 BACKGROUND

• Marshall GD Jr, Agarwal SK, Lloyd C, Cohen L, Henninger EM, Morris GJ. Cytokine dysregulation associated with exam stress in healthy medical students. Brain Behav Immun. 1998 Dec;12(4):297-307. doi: 10.1006/brbi.1998.0537.

  PMID: 10080859 BACKGROUND

• Zucoloto ML, Shibakura MEW, Pavanin JV, Garcia FT, da Silva Santos PS, Maciel AP, de Barros Gallo C, Souza NV, Innocentini LMAR, Humberto JSM, Motta ACF. Severity of oral lichen planus and oral lichenoid lesions is associated with anxiety. Clin Oral Investig. 2019 Dec;23(12):4441-4448. doi: 10.1007/s00784-019-02892-2. Epub 2019 Apr 15.

  PMID: 30989337 BACKGROUND

• Vallejo MJ, Huerta G, Cerero R, Seoane JM. Anxiety and depression as risk factors for oral lichen planus. Dermatology. 2001;203(4):303-7. doi: 10.1159/000051777.

  PMID: 11752817 BACKGROUND

• Alves MG, do Carmo Carvalho BF, Balducci I, Cabral LA, Nicodemo D, Almeida JD. Emotional assessment of patients with oral lichen planus. Int J Dermatol. 2015 Jan;54(1):29-32. doi: 10.1111/ijd.12052. Epub 2014 Sep 10.

  PMID: 25209436 BACKGROUND

• Chaudhary S. Psychosocial stressors in oral lichen planus. Aust Dent J. 2004 Dec;49(4):192-5. doi: 10.1111/j.1834-7819.2004.tb00072.x.

  PMID: 15762340 BACKGROUND

• Soto Araya M, Rojas Alcayaga G, Esguep A. Association between psychological disorders and the presence of Oral lichen planus, Burning mouth syndrome and Recurrent aphthous stomatitis. Med Oral. 2004 Jan-Feb;9(1):1-7. English, Spanish.

  PMID: 14704611 BACKGROUND

• Rojo-Moreno JL, Bagan JV, Rojo-Moreno J, Donat JS, Milian MA, Jimenez Y. Psychologic factors and oral lichen planus. A psychometric evaluation of 100 cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Dec;86(6):687-91. doi: 10.1016/s1079-2104(98)90205-0.

  PMID: 9868726 BACKGROUND

• McCartan BE. Psychological factors associated with oral lichen planus. J Oral Pathol Med. 1995 Jul;24(6):273-5. doi: 10.1111/j.1600-0714.1995.tb01181.x.

  PMID: 7562664 BACKGROUND

• Kramer IR, Lucas RB, Pindborg JJ, Sobin LH. Definition of leukoplakia and related lesions: an aid to studies on oral precancer. Oral Surg Oral Med Oral Pathol. 1978 Oct;46(4):518-39. No abstract available.

  PMID: 280847 BACKGROUND

• Warnakulasuriya S, Kujan O, Aguirre-Urizar JM, Bagan JV, Gonzalez-Moles MA, Kerr AR, Lodi G, Mello FW, Monteiro L, Ogden GR, Sloan P, Johnson NW. Oral potentially malignant disorders: A consensus report from an international seminar on nomenclature and classification, convened by the WHO Collaborating Centre for Oral Cancer. Oral Dis. 2021 Nov;27(8):1862-1880. doi: 10.1111/odi.13704. Epub 2020 Nov 26.

  PMID: 33128420 BACKGROUND

• van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x.

  PMID: 12969224 BACKGROUND

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Original care providers who are preforming the follow up would be blinded to the intervention. The provider of the intervention is not aware of the state of the lichen planus of each patient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 60 randomised patients as well as 30 retrospective

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 20, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IL (1)