NCT04336787

Brief Summary

We hypothesized: During the COVID-19 pandemic, the sleep quality of pregnant women decreases. During the COVID-19 epidemic, the stress level of pregnant women increases. During the COVID-19 epidemic, the level of physical activity of pregnant women decreases. Aims: The aim of the study is to determine the sleep quality, stress level and physical activity level of pregnant women who maintain the home quarantine during the COVID-19 pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 12, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

28 days

First QC Date

April 3, 2020

Last Update Submit

October 7, 2021

Conditions

Keywords

Covid-19coronavirus infectionquarantinesleep disordersstress levelphysical activity levelpregnancy

Outcome Measures

Primary Outcomes (4)

  • International Physical Activity Questionnaire

    This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs\*min\*days) + Mod (METs\*min\*days) + Vig (METs\*min\*days) 1\. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week

    Baseline of the study

  • Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.

    Baseline of the study

  • Perceived Stress Scale

    The Perceived Stress Scale (PSS) is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful. Each item is rated on a 5-point scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often) and summed to create a total score. PSS-14 has strong internal consistency (α = .84 to .86) and good test-retest reliability (r = .85 over a 2-day period, r = .55 over a 6-week period.

    Baseline of the study

  • Numerical Pain Rating Scale

    The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale rates the pain from 0 (no pain) to 10 (worst pain).

    Baseline of the study

Interventions

SurveyOTHER

A Google Survey which included that consent form, demographic information form, International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index, Perceived Stress Scale and The Numeric Rating Scale will be created. Then the survey link will be shared via social media such as Whatsapp, Facebook, etc.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women, in different trimesters, who need to be active but have to stay at home because of social quarantine implementation that is for preventing COVID-19 infection will be evaluated.

You may qualify if:

  • Volunteer to participate in the study
  • Being pregnant
  • Aged between 18 - 45
  • To understand Turkish
  • Spend most of the day at home

You may not qualify if:

  • Risky pregnancy status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsSleep Wake Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 7, 2020

Study Start

April 12, 2020

Primary Completion

May 10, 2020

Study Completion

June 10, 2020

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations