NCT06520241

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

July 21, 2024

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Depression-Anxiety-Stress Scale

    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

    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)

Interventions

Data were collected using the Personal Information Form, Depression-Anxiety-Stress Scale (DASS-21), and Oral Health Impact Scale (OHIP-14-TR).

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, 78100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep BruxismDepressionAnxiety DisordersMouth Diseases

Interventions

Gravidity

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPregnancyReproductionReproductive HistoryEpidemiologic FactorsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

July 21, 2024

First Posted

July 25, 2024

Study Start

September 1, 2023

Primary Completion

September 1, 2023

Study Completion

November 30, 2023

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations