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临床试验/NCT07320144
NCT07320144尚未招募不适用

Investigation of the Effects of a Biopsychosocial Approach Added to Physiotherapy on Stress, Sleep Disturbance, and Bruxism in Individuals With Temporomandibular Disorders

Betül Özata0 个研究点目标入组 40 人开始时间: 2026年1月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Stress Level

研究概览

简要总结

Temporomandibular disorders are conditions that affect the jaw joint and surrounding muscles and may cause pain, limited jaw movement, stress, sleep problems, and teeth grinding. Physiotherapy is commonly used to manage these problems, but psychological and social factors may also influence symptoms.

The purpose of this study is to examine whether adding a biopsychosocial approach to physiotherapy improves stress levels, sleep quality, and bruxism in individuals with temporomandibular disorders. Participants will receive either physiotherapy alone or physiotherapy combined with education about pain, stress management, and sleep habits. The results of this study may help improve treatment strategies for people with temporomandibular disorders.

详细描述

This randomized interventional study aims to investigate the effects of adding a biopsychosocial approach to physiotherapy in individuals with temporomandibular disorders. Temporomandibular disorders are multifactorial conditions influenced by physical, psychological, and social factors. While physiotherapy is effective in reducing pain and improving function, psychosocial factors such as stress, sleep disturbance, and bruxism may contribute to symptom persistence.

Participants will be randomly assigned to one of two groups. The control group will receive a standardized physiotherapy program including therapeutic exercises and manual therapy targeting the temporomandibular joint and related musculoskeletal structures. The intervention group will receive the same physiotherapy program in addition to a biopsychosocial intervention consisting of pain neuroscience education, stress management strategies, and sleep hygiene education.

Outcome measures will include stress levels, sleep disturbance, and bruxism severity as primary outcomes, and pain intensity and jaw function as secondary outcomes. Assessments will be conducted at baseline and after the intervention period. This study is expected to provide evidence on the effectiveness of integrating a biopsychosocial approach into physiotherapy for temporomandibular disorders.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with temporomandibular disorders
  • Age between 18 and 65 years
  • Presence of stress, sleep disturbance, or bruxism symptoms
  • Ability to understand and follow study instructions
  • Willingness to participate and provide informed consent

排除标准

  • History of temporomandibular joint surgery
  • Presence of neurological, rheumatological, or systemic diseases affecting the musculoskeletal system
  • Current orthodontic treatment
  • Use of medications that may affect pain perception or sleep
  • Pregnancy

研究组 & 干预措施

Physiotherapy

Active Comparator

Participants in this arm will receive a standardized physiotherapy program for temporomandibular disorders, including therapeutic exercises and manual therapy targeting the temporomandibular joint and associated musculoskeletal structures.

干预措施: Physiotherapy Program (Other)

Physiotherapy Plus Biopsychosocial Approach

Experimental

Participants in this arm will receive the same physiotherapy program combined with a biopsychosocial intervention including pain education, stress management strategies, and sleep hygiene education.

干预措施: Physiotherapy Program (Other)

Physiotherapy Plus Biopsychosocial Approach

Experimental

Participants in this arm will receive the same physiotherapy program combined with a biopsychosocial intervention including pain education, stress management strategies, and sleep hygiene education.

干预措施: Biopsychosocial Intervention (Other)

结局指标

主要结局

Stress Level

时间窗: Baseline and 6 weeks

Stress level will be assessed using a validated self-reported questionnaire to evaluate perceived stress in individuals with temporomandibular disorders.

次要结局

  • Sleep Disturbance(Baseline and 6 weeks)
  • Bruxism Severity(Baseline and 6 weeks)

研究者

发起方
Betül Özata
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Betül Özata

Physiotherapist, MSc Student

Istinye University

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