Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women

NCT ID: NCT06413784

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-02-01

Brief Summary

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Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.

Methods: Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.

Detailed Description

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Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.

Methods: This study is a single-blind (participants), parallel trial. It was performed in line with the principles of the Declaration of Helsinki. The followings were the study's inclusion requirements: being between the ages of 18-40, having a singleton pregnancy, being in the second trimester, and not having any known chronic disease. Exclusion criteria are working night shifts, having a high-risk pregnancy, and having a neurological or orthopedic disease. Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.

Conditions

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Chronotype Pregnancy Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study is a single-blind (participants), parallel trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants were blind

Study Groups

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Morning Chronotype

Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined.

Group Type EXPERIMENTAL

Morning chronotype

Intervention Type OTHER

Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined.

Intermediate chronotype

Sleep quality, gestational diabetes and pregnancy symptoms of Intermediate chronotype individuals were examined.

Group Type EXPERIMENTAL

Intermediate chronotype

Intervention Type OTHER

Sleep quality, gestational diabetes and pregnancy symptoms of intermediate chronotype individuals were examined.

Evening chronotype

Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined.

Group Type EXPERIMENTAL

Evening chronotype

Intervention Type OTHER

Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined.

Interventions

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Morning chronotype

Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined.

Intervention Type OTHER

Intermediate chronotype

Sleep quality, gestational diabetes and pregnancy symptoms of intermediate chronotype individuals were examined.

Intervention Type OTHER

Evening chronotype

Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* being between the ages of 18-40,
* having a singleton pregnancy, being in the second trimester,
* not having any known chronic disease.

Exclusion Criteria

* working night shifts,
* having a high-risk pregnancy,
* having a neurological or orthopedic disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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merve yilmaz menek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MERVE YILMAZ MENEK, PhD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cassidy EM, Bailey CP, Napolitano MA, Vyas AN. Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study. Prev Med Rep. 2022 Dec 6;31:102088. doi: 10.1016/j.pmedr.2022.102088. eCollection 2023 Feb.

Reference Type RESULT
PMID: 36820370 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/36820370/

Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study.

Other Identifiers

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10840098-772.02-6181

Identifier Type: -

Identifier Source: org_study_id

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