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Investigation of Occupational Balance in Individuals With and Without Bruxism

Primary Purpose

Bruxism, Occupational Problems

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Occupational balance assessment
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bruxism focused on measuring Bruxism, Occupational Balance, Stress

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: To be volunteer Exclusion Criteria: Psychological disorders, Neurological disorders, Orthopedic disorders, Cognitive impairment.

Sites / Locations

  • Tokat Gaziosmanpasa University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Individuals with bruxism

Individuals without bruxism

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fonseca Anamnestic Index
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.
Occupational Balance Questionnaire
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.
Perceived Stress Scale
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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 21, 2023
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT06052709
Brief Title
Investigation of Occupational Balance in Individuals With and Without Bruxism
Official Title
Investigation of Occupational Balance in Individuals With and Without Bruxism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism, Occupational Problems
Keywords
Bruxism, Occupational Balance, Stress

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individuals with bruxism
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Individuals without bruxism
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Occupational balance assessment
Intervention Description
There is no intervention. The presence and severity of temporomandibular disorders, occupational balance, and stress levels of individuals will be evaluated.
Primary Outcome Measure Information:
Title
Fonseca Anamnestic Index
Description
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.
Time Frame
up to 3 months
Title
Occupational Balance Questionnaire
Description
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.
Time Frame
up to 3 months
Title
Perceived Stress Scale
Description
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.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be volunteer Exclusion Criteria: Psychological disorders, Neurological disorders, Orthopedic disorders, Cognitive impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com
Facility Information:
Facility Name
Tokat Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60250
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com

12. IPD Sharing Statement

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Investigation of Occupational Balance in Individuals With and Without Bruxism

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