The Effect of Stress, Anxiety, and Depression Experienced by Pregnant Women on Sleep Bruxism and Oral Health

July 24, 2024 updated by: Burcu KUCUKKAYA, Trakya University

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

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bartin, Turkey, 78100
        • Bartın University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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