- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06520241
The Effect of Stress, Anxiety, and Depression Experienced by Pregnant Women on Sleep Bruxism and Oral Health
The Effect of Stress, Anxiety, and Depression Experienced by Pregnant Women on Sleep Bruxism and Oral Health: Cross-sectional Study
Background The oral health of pregnant women affects not only the systemic health of the mother but also the birth outcome of the fetus. Therefore, oral health management of pregnant women is important for both maternal and fetal health.
Objectives The study aimed to examine the effects of stress, anxiety, and depression experienced by pregnant women on sleep bruxism and oral health.
Methodology This cross-sectional study was conducted between September and November 2023 on 321 pregnant women who volunteered to participate in the study by posting on social media forum pages via the web. Data were collected using the Personal Information Form, Depression-Anxiety-Stress Scale (DASS-21), and Oral Health Impact Scale (OHIP-14-TR). Descriptive statistical methods, the Kruskal-Wallis test, Mann-Whitney-U test, and Spearman correlation test were used to analyze the data.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bartin, Turkey, 78100
- Bartın University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women over the age of 18 who were pregnant, diagnosed with sleep bruxism, and who could read and write were included in the study.
Exclusion Criteria:
- Women who refused to participate in the study, who could not be contacted, who had serious dental health problems in the last six months, who had dentures, who had serious stress disorder in the last six months, who filled out the data collection form incompletely, who had hearing-vision problems or intellectual disability, and who had diagnosed psychological illness were not included in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression-Anxiety-Stress Scale
Time Frame: 1 day (collected once)
|
Sarıçam (2018) adapted the scale developed by Lovibond and Lovibond (1995) into Turkish.
In the scale consisting of depression, anxiety, and stress sub-dimensions, each sub-dimension consists of seven items.
Scale items are scored from 0 to 3 (0=never and 3=always).
Scores between 0 and 21 can be obtained from the scale sub-factors.
Higher scores indicate higher levels of depression, anxiety, and stress.
|
1 day (collected once)
|
|
Oral Health Impact Scale
Time Frame: 1 day (collected once)
|
Oral Health Impact Scale (OHIP-14) with an internal consistency coefficient (Cronbach alpha) of 0.74, which was conducted by Başol et al. in 2014 for Turkish validity and reliability.
The scale consists of 14 items with a 5-point Likert response scale (never-0; rarely-1; sometimes-2; often-3; very often-4) and seven subscales, each consisting of two items: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.
The total score obtained from the scale is obtained by summing the scores given to each item, and the total scale score range varies between 0 and 56.
|
1 day (collected once)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-SBB-0546
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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