HypnOLP Trial Hypnotherapy for Oral Lichen Planus - a Single Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in clinical expression of Oral Lichen Planus
研究概览
简要总结
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
详细描述
Background:
Lichen planus (LP) is an immune-mediated skin and mucous membrane disease that mainly affects middle-aged adults of both sexes with a slight tendency to women. The precise prevalence of LP is unknown, but it is estimated that the oral form (OLP) alone is expressed in about 1-2% of the population. OLP is a chronic disease and it is considered by the World Health Organization (WHO) as a pre-malignant condition. OLP presents in five clinical forms - reticular, plaque-like, erythematous/atrophic, erosive/ulcerative and bullous. The reticular form is the most common and is characterized by white papules and/or white mesh-like stripes called Wickham's striae, typically bilaterally and symmetrically distributed. The most affected site is the posterior buccal mucosa followed by the tongue, gingiva and labial mucosa.2 Usually, this condition is asymptomatic even if it is diffuse, but the erythematous, erosive and ulcerative forms might cause a painful burning sensation. In 1978 the WHO published diagnostic criteria for OLP based on clinical and histopathological characteristics and in 2003 van der Meij and van der Waal modified these criteria, which are accepted till this day.
Despite a vast number of studies, the etiology of OLP remains unknown. It is believed that OLP is a result of a local cell-mediated immune response, involving antigen-presenting cells and inflammatory infiltrate predominantly of T lymphocytes, but its precipitating factors have not been determined. Some conditions have been associated with OLP, including among others, genetic predisposition, specific microorganisms, several systemic health conditions, and emotional disorders. The latter have been thoroughly investigated and some studies have showed that OLP patients, especially those with the erythematous/erosive forms, have higher state of anxiety and depression than non-OLP individuals. It has been suggested that psychological factors can alter the functionality of the immune system, leading to the development of autoimmune diseases. To date, no study has conclusively demonstrated a cause-and-effect relationship and more investigations about the possible correlation of anxiety and emotions with the severity of OLP are needed.
Hypnosis is a natural human phenomenon and every human tends to have trance like events several times a day. Techniques for induction and deepening of the hypnotic trance can be utilized in order to maintain this state and access aspects of psyche and physiology that are not readily accessible in the ordinary waking state.
Ample literature is available on the use of hypnosis for treatment of medical conditions that are exacerbated by emotions such as autoimmune and autoinflammatory conditions. That being said there are only anecdotal reports of hypnotherapy being used for Lichen Planus of the skin and non for OLP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Psychoeducation and Hypnotherapy Group
30 Patients randomized to undergo psychoeducation and hypnotherapy
干预措施: Hypnosis aimed at stress reduction and health of the oral mucosa (Behavioral)
Psychoeducation and Hypnotherapy Group
30 Patients randomized to undergo psychoeducation and hypnotherapy
干预措施: Psychoeducation (Behavioral)
Psychoeducation Group
30 Patients selected for psychoeducation with out hypnotherapy
干预措施: Psychoeducation (Behavioral)
Non intervention group - retrospectively analyzed
30 age matched patients from the oral mucosal clinic who's course and presentation of lichen planus would be retrospectively analyzed
结局指标
主要结局
Improvement in clinical expression of Oral Lichen Planus
时间窗: 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
次要结局
- Stress reduction and overall improvement in quality of life(3 months)
