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Clinical Trials/NCT07320144
NCT07320144
Not yet recruiting
Not Applicable

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

Betül Özata0 sites40 target enrollmentStarted: January 15, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Betül Özata
Enrollment
40
Primary Endpoint
Stress Level

Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: 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.

Intervention: 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.

Intervention: Biopsychosocial Intervention (Other)

Outcomes

Primary Outcomes

Stress Level

Time Frame: Baseline and 6 weeks

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

Secondary Outcomes

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

Investigators

Sponsor
Betül Özata
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Betül Özata

Physiotherapist, MSc Student

Istinye University

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