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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04922346
Other study ID # E-18457941-050.99-10607
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date August 1, 2021

Study information

Verified date August 2022
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to determine the effects of physical activity on fear of childbirth (tokophobia) in pregnant women.


Description:

Fear of childbirth is defined as the fear felt and experienced before, during and after birth. Fear of childbirth is an acceptable level of fear and motivates the woman to prepare for the birth. However, if the fear developed before pregnancy and/or the severity of the fear increased during pregnancy, this situation is called "Tokophobia". Physical activity is defined as body movements that are performed by using the body's muscles and joints, require energy expenditure above the basal level, can be performed at different intensities, increase heart rate and respiration, and occur with the contraction of large muscle groups. It has been shown in the literature that physical activity in pregnant women contributes to the health of both the mother and the infant. Several studies have reported the benefits of physical activity and exercise in preventing many risks of pregnancy, including lowering the risks of excess weight gain, preeclampsia, gestational diabetes, gestational hypertension, prenatal depression and macrosomia, and improving psychological well-being. Despite the reported benefits of regular physical activity in the literature, it has been reported that the level of physical activity during pregnancy is lower compared to the pre-pregnancy period.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date August 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: Having difficulty in communicating in order to understand and answer the evaluation questions correctly, Being at 14-40 weeks of gestation, Pregnancies with regular perinatal control. Exclusion Criteria: Being chronically ill or obese Individuals with a history of orthopedic, neurological, rheumatological or cardiopulmonary disease or surgery, Having 2 or more miscarriages, Multiple pregnancy, High-risk pregnancy Continuous vaginal bleeding Pre-pregnancy Body Mass Index (BMI) less than 17.5.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Marmara University Maltepe Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wijma Delivery Expectation/Experience Scale (W-DEQ) The "Wijma Delivery Expectation/Experience Scale (W-DEQ)" was developed by Klaas and Barbro Wijma, using the clinical experiences of women regarding the fear of childbirth. The W-DEQ scale version A was developed to measure the experiences of pregnant women before childbirth. Responses are on a six-point Likert-type scale from 0 to 5. 0 means "totally" and 5 as "not at all". While the minimum score on this scale is 0, the maximum score is 165. Higher scores indicate that women have a higher fear of childbirth. Baseline
Primary The Pregnancy Physical Activity Questionnaire The pregnancy physical activity questionnaire was developed by Lisa Chasan-Taber et al. in 2004 to determine the physical activity levels of pregnant women only. This questionnaire determines the activity level of pregnant women based on the time they spend during 32 activities. Baseline
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