Covid-19NCT04336787
Physical Activity Level, Stress Level, Sleep Quality in Pregnant Women During Covid-19 Quarantine
An observational study of Covid-19 and Coronavirus Infection, run by Istanbul Kültür University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Covid-19, Coronavirus Infection, Pregnancy Related
- What is being tested?
- Survey
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2020to 10 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- Volunteer to participate in the study
- Being pregnant
- Aged between 18 - 45
- To understand Turkish
- Spend most of the day at home
Who cannot join
- Risky pregnancy status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination Of Physical Activity, Sleep And Stress Level Of Pregnant Women In The Covıd-19 Quarantine Period
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.
Read the detailed description
A novel coronavirus (COVID-19) first reported in Wuhan, China in December 2019. The COVID-19 has spread rapidly and posed a health threat of unknown magnitude globally. World Health Organization (WHO) declared the new coronavirus outbreak is a public health emergency of international concern on January 30, 2020 (1).
The first COVID-19 case was detected in Turkey on March 11, 2020, treatment-resistant cases of pneumonia spread rapidly. Swift and protective measures have been taken to prevent the spread of COVID-19. The protective measures included early diagnosis, public health quarantine or physical isolation and symptomatic monitoring of contacts as well as confirmed and suspended cases.
Quarantine or physical isolation, who may have or have been infected by a contagious disease to control or limit contamination. Modern quarantine strategies include short- and medium-term deadlocks, voluntary home curfew, cancellation of planned social and public events, restrictions on the assembly of groups of people, closure of public transport systems and other travel bans. Universities were closed during the spring semester and various institutions interrupted their activities. In addition, people were asked to stay home as much as possible to avoid unnecessary social contact. Pregnant women should take the same precautions to avoid COVID-19 infection as other people.
Going early and regularly for prenatal care can help moms-to-be (and their babies) stay healthy. Regular care lets doctors find and deal with any problems as soon as possible. It's important to start prenatal care as early as possible - ideally, before a woman even becomes pregnant. However, due to the increasing number of COVID-19 patients in Turkey, it is not recommended to go to the hospitals unless it is obligatory. This is thought to be another reason for anxiety in pregnant women, in addition to the hours spent at home for social isolation. Moreover, the uncertainty of the hospital conditions can be thought as another cause of stress among pregnant women in the last trimester.
Additionally, it is obvious that physical activity during pregnancy is beneficial for both the woman and foetus. There is some evidence that physical activity during pregnancy is associated with a reduced length of labor and delivery complications. Taking a brisk walk, swimming and water workouts, low-impact aerobics classes, Yoga and Pilates classes are really preferred. However, it is not possible to do such group exercises and outdoor sports due to social isolation and it can affect the physical activity level of the pregnant women.
According to these informations, we hypothesized the followings:
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.
- Sleep-wake hours of the pregnant women participating in our study will be questioned by the questionnaire prepated by the study team.
- Pain conditions of the participants of our study will be questioned with the questions prepared and "Visual Analogue Scale-VAS",
- The physical activity level of the pregnant women participating in the study will be evaluated with the "International Physical Activity Questionnaire -IPAQ".
- Since the pregnancy itself and the lifestyle after the pandemic is thought to cause sleep disorder and stress, the stress level will be evaluated with the "Perceived Stress Scale" and the sleep quality will be evaluated with the "Pittsburg Sleep Quality Index".
- Conditions
- Covid-19, Coronavirus Infection, Pregnancy Related
- Being tested
- Survey
- Keywords
- Covid-19, coronavirus infection, quarantine, sleep disorders, stress level, physical activity level, pregnancy
- Medical subject headings
- COVID-19, Coronavirus Infections, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
- 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start12 Apr 2020
- Primary completion10 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kültür University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Gamze Ertürk, Istanbul Kültür University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336787
- Sponsor's protocol ID
- FADP-2
- Status last verified
- Oct 2021
- First submitted
- 3 Apr 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Of Physical Activity, Sleep And Stress Level Of Pregnant Women In The Covıd-19 Quarantine Period
- ClinicalTrials.gov ID
- NCT04336787
- Acronym / sponsor ID
- FADP-2
- Conditions
- Covid-19, Coronavirus Infection, Pregnancy Related
- Keywords
- Covid-19, coronavirus infection, quarantine, sleep disorders, stress level, physical activity level, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Kültür UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A novel coronavirus (COVID-19) first reported in Wuhan, China in December 2019. The COVID-19 has spread rapidly and posed a health threat of unknown magnitude globally. World Health Organization (WHO) declared the new coronavirus outbreak is a public health emergency of international concern on January 30, 2020 (1).
The first COVID-19 case was detected in Turkey on March 11, 2020, treatment-resistant cases of pneumonia spread rapidly. Swift and protective measures have been taken to prevent the spread of COVID-19. The protective measures included early diagnosis, public health quarantine or physical isolation and symptomatic monitoring of contacts as well as confirmed and suspended cases.
Quarantine or physical isolation, who may have or have been infected by a contagious disease to control or limit contamination. Modern quarantine strategies include short- and medium-term deadlocks, voluntary home curfew, cancellation of planned social and public events, restrictions on the assembly of groups of people, closure of public transport systems and other travel bans. Universities were closed during the spring semester and various institutions interrupted their activities. In addition, people were asked to stay home as much as possible to avoid unnecessary social contact. Pregnant women should take the same precautions to avoid COVID-19 infection as other people.
Going early and regularly for prenatal care can help moms-to-be (and their babies) stay healthy. Regular care lets doctors find and deal with any problems as soon as possible. It's important to start prenatal care as early as possible - ideally, before a woman even becomes pregnant. However, due to the increasing number of COVID-19 patients in Turkey, it is not recommended to go to the hospitals unless it is obligatory. This is thought to be another reason for anxiety in pregnant women, in addition to the hours spent at home for social isolation. Moreover, the uncertainty of the hospital conditions can be thought as another cause of stress among pregnant women in the last trimester.
Additionally, it is obvious that physical activity during pregnancy is beneficial for both the woman and foetus. There is some evidence that physical activity during pregnancy is associated with a reduced length of labor and delivery complications. Taking a brisk walk, swimming and water workouts, low-impact aerobics classes, Yoga and Pilates classes are really preferred. However, it is not possible to do such group exercises and outdoor sports due to social isolation and it can affect the physical activity level of the pregnant women.
According to these informations, we hypothesized the followings:
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.
- Sleep-wake hours of the pregnant women participating in our study will be questioned by the questionnaire prepated by the study team.
- Pain conditions of the participants of our study will be questioned with the questions prepared and "Visual Analogue Scale-VAS",
- The physical activity level of the pregnant women participating in the study will be evaluated with the "International Physical Activity Questionnaire -IPAQ".
- Since the pregnancy itself and the lifestyle after the pandemic is thought to cause sleep disorder and stress, the stress level will be evaluated with the "Perceived Stress Scale" and the sleep quality will be evaluated with the "Pittsburg Sleep Quality Index".
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- Volunteer to participate in the study
- Being pregnant
- Aged between 18 - 45
- To understand Turkish
- Spend most of the day at home
Key exclusion criteria (1 listed)
- Risky pregnancy status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyA 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. | Other | – |
Primary outcome
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
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Covid-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Coronavirus Infection, run by Istanbul Kültür University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire (time frame: Baseline of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.