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

Covid-19 Clinical Trial

Official title:

Determination Of Physical Activity, Sleep And Stress Level Of Pregnant Women In The Covıd-19 Quarantine Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336787
• Other study ID #: FADP-2
• Status: Completed
• Start date: April 12, 2020
• Est. completion date: June 10, 2020

Study information

• Verified date: October 2021
• Source: Istanbul Kültür University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

1. Sleep-wake hours of the pregnant women participating in our study will be questioned by the questionnaire prepated by the study team.

2. Pain conditions of the participants of our study will be questioned with the questions prepared and "Visual Analogue Scale-VAS",

3. The physical activity level of the pregnant women participating in the study will be evaluated with the "International Physical Activity Questionnaire -IPAQ".

4. 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 10, 2020
• Est. primary completion date: May 10, 2020
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University - Cerrahpasa	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Kültür University	Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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 (a = .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
Primary	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