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Physical Activity Level, Stress Level, Sleep Quality in Pregnant Women During Covid-19 Quarantine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336787
Recruitment Status : Not yet recruiting
First Posted : April 7, 2020
Last Update Posted : April 13, 2020
Sponsor:
Collaborator:
Istanbul University-Cerrahpasa
Information provided by (Responsible Party):
Gamze Ertürk, Istanbul Kültür University

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.


Condition or disease Intervention/treatment
Covid-19 Coronavirus Infection Pregnancy Related Other: Survey

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Determination Of Physical Activity, Sleep And Stress Level Of Pregnant Women In The Covıd-19 Quarantine Period
Estimated Study Start Date : April 12, 2020
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : June 10, 2020



Intervention Details:
  • Other: Survey
    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.


Primary Outcome Measures :
  1. International Physical Activity Questionnaire [ Time Frame: Baseline of the study ]

    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


  2. Pittsburgh Sleep Quality Index [ Time Frame: Baseline of the study ]
    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.

  3. Perceived Stress Scale [ Time Frame: Baseline of the study ]
    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.

  4. Numerical Pain Rating Scale [ Time Frame: Baseline of the study ]
    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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Risky pregnancy status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336787


Contacts
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Contact: Ayşe Zengin Alpözgen, assistant professor (212) 866 37 00 43144 azengin@istanbul.edu.tr

Locations
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Turkey
Istanbul University - Cerrahpaşa
Istanbul, Turkey
Contact: Ayşe Zengin Alpözgen, Assistant Professor         
Principal Investigator: Halenur Evrendilek, PhD Student         
Principal Investigator: Başak Polat, PhD Student         
Principal Investigator: Çiçek Duman, PhD Student         
Principal Investigator: Tuğçe Tahmaz, PhD Student         
Principal Investigator: Funda Aküzüm, PhD Student         
Principal Investigator: Gamze Ertürk Uzunoğlu, PhD Student         
Sponsors and Collaborators
Istanbul Kültür University
Istanbul University-Cerrahpasa
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Responsible Party: Gamze Ertürk, Research Assistant, Istanbul Kültür University
ClinicalTrials.gov Identifier: NCT04336787    
Other Study ID Numbers: FADP-2
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamze Ertürk, Istanbul Kültür University:
Covid-19
coronavirus infection
quarantine
sleep disorders
stress level
physical activity level
pregnancy
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases