跳至主要内容
临床试验/NCT06898749
NCT06898749尚未招募不适用

Impact of Canine Mediation Practice in Psychomotor Therapy on Improving the Quality of Life in Adult Epileptic Patients.

Fondation Ophtalmologique Adolphe de Rothschild0 个研究点目标入组 76 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
76
主要终点
Improvement of quality of life

研究概览

简要总结

In addition to the search for new pharmaceutical or surgical solutions that could improve the therapeutic management of epileptic individuals, it is interesting to ask whether other complementary approaches, such as canine mediation in psychomotor therapy, could enhance the quality of life in this population.

However, there is currently no evidence indicating that exposure to animals through mediation sessions would be beneficial for epileptic individuals, particularly regarding their quality of life, anxiety, emotional management, or cognition (such as social cognition). In the absence of current data in this population, it seems pertinent to study the impact of this practice on people with epilepsy. Furthermore, beyond quality of life, it would be valuable to examine whether it also influences anxiety or the frequency of seizures in individuals with epilepsy (a phenomenon reported for epileptic individuals living with a pet dog or a service dog). Canine mediation could help better manage and regulate the emotions of epileptic individuals, as well as improve their self-esteem.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • •Person aged ≥ 18 years
  • •Presenting pharmacoresistant epilepsy according to the criteria of the International League Against Epilepsy
  • •Requiring psychomotor therapy sessions for one of the following indications:
  • •Difficult emotional and relational management And/or global motor difficulties And/or body schema organization disorder And/or temporo-spatial disorder
  • •Explicit consent or no opposition to participation in the study by the patient and/or their legal representative or guardian
  • •Image rights consented by the patient and their legal representative or guardian, if applicable
  • •Hospitalization or residence at the Teppe Institute or at the FAM (Foyer d'Accueil Médicalisé) des 4 Jardins planned for at least 3 months
  • •Affiliated with or a beneficiary of a social security scheme

排除标准

  • •Fear or phobia of dogs
  • •Epileptic person benefiting from a legal protection measure other than guardianship or curatorship
  • •Person with insufficient cognitive abilities to respond to the questionnaires
  • •Pregnant or breastfeeding woman

研究组 & 干预措施

canine mediation in psychomotor therapy

Experimental

Group psychomotor therapy sessions combined with canine mediation

(1 session per week for 10 weeks)

干预措施: canine mediation (Other)

standard psychomotor therapy

Active Comparator

Standard group psychomotor therapy sessions (1 session per week for 10 weeks)

干预措施: standard psychomotor therapy (Other)

结局指标

主要结局

Improvement of quality of life

时间窗: Day 0 and Day 7 after the end of the 10 sessions

Increase in the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) score of at least 5 points between inclusion and one week after the completion of the 10 sessions. The score of the QOLIE-31 (Quality of Life in Epilepsy Inventory-31) ranges from 0 to 100. A score of 0 represents the worst possible quality of life, while a score of 100 represents the best possible quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

相似试验