- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06052709
Investigation of Occupational Balance in Individuals With and Without Bruxism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Occupation refers to daily life activities and task groups that are named, organized, given value and meaning by individuals and a culture. Occupation is everything people do to keep themselves busy, including taking care of themselves, enjoying life, and contributing to the social and economic fabric of their communities.
Bruxism is a parafunctional habit among temporomandibular disorders that occurs as a result of clenching and grinding teeth and overloading the stomatognathic structures. At the same time, bruxism is the chewing movement of the mandible, characterized by involuntary, rhythmic and non-functional teeth clenching and grinding, usually seen during sleep, and manifested by severe head and neck pain, limitation in jaw movements, pain and spasm in the chewing muscles. Although its etiology cannot be fully explained, it is thought that factors such as stress, occlusal disorders, allergies and sleep quality may be the source.
The deterioration or decrease in occupational balance may also be associated with people's quality of life. Occupational imbalance is reported to affect both physical and psychological state, creating significant stress on the body and mind, causing mental health problems and burnout.
Considering that occupational balance and bruxism are negatively affected by stress, this study aims to determine whether there is a difference in terms of occupational balance between individuals with and without bruxism.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Halime ARIKAN, PhD
- Phone Number: +90 546 576 51 32
- Email: halimearikan92@gmail.com
Study Locations
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Tokat, Turkey, 60250
- Tokat Gaziosmanpasa University
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Contact:
- Halime ARIKAN, PhD
- Phone Number: +90 546 576 51 32
- Email: halimearikan92@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To be volunteer
Exclusion Criteria:
- Psychological disorders,
- Neurological disorders,
- Orthopedic disorders,
- Cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Individuals with bruxism
After the sociodemographic information of individuals is questioned, the presence and severity of temporomandibular joint disorders with the Fonseca Anamnestic Index, self-reported occupational balance with the Activity-Role Balance Questionnaire, and the individuals' stress levels with the Perceived Stress Scale will be evaluated.
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There is no intervention.
The presence and severity of temporomandibular disorders, occupational balance, and stress levels of individuals will be evaluated.
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Placebo Comparator: Individuals without bruxism
After the sociodemographic information of individuals is questioned, the presence and severity of temporomandibular joint disorders with the Fonseca Anamnestic Index, self-reported occupational balance with the Activity-Role Balance Questionnaire, and the individuals' stress levels with the Perceived Stress Scale will be evaluated.
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There is no intervention.
The presence and severity of temporomandibular disorders, occupational balance, and stress levels of individuals will be evaluated.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fonseca Anamnestic Index
Time Frame: up to 3 months
|
The presence and severity of temporomandibular disorders in individuals will be questioned with the Fonseca Anamnestic Index.
The Fonseca Anamnestic Index consists of 10 questions.
The participant is asked to answer each question as 'Yes' (10 points), 'No' (0 points), and 'Sometimes' (5 points).
The questionnaire score is given points for all questions, and the severity of temporomandibular disorders is classified according to the total score: no temporomandibular disorders (0-15 points), mild temporomandibular disorders (20-40 points), moderate temporomandibular disorders (45-65 points), severe temporomandibular disorders (70-100).
Turkish version, validity, and reliability study was conducted.
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up to 3 months
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Occupational Balance Questionnaire
Time Frame: up to 3 months
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Occupational Balance Questionnaire is a scale that measures self-reported occupational balance in different dimensions.
The purpose of the scale is to measure the satisfaction of the individual according to the amount and variety of daily activities and to define his/her occupational balance according to the results obtained.
The 11 items in the scale are scored on a 4-point scale from "strongly disagree" to "strongly agree".
The total score is obtained by summing the individual items and ranges from 0 to 33, with higher scores indicating greater occupational balance.
Turkish version, validity and reliability study was conducted.
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up to 3 months
|
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Perceived Stress Scale
Time Frame: up to 3 months
|
Individuals' stress levels will be measured with the Perceived Stress Scale.
The Perceived Stress Scale, consisting of 14 items, measures how stressful some situations in a person's life are perceived.
Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)".
7 of the items containing positive statements are reverse scored-scores of the Perceived Stress Scale range from 0 to 56.
A high score indicates a person's perception of stress is high.
A Turkish version, validity, and reliability study of the Perceived Stress Scale was conducted.
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up to 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13.20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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