NCT04922346

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

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

Study Start

First participant enrolled

May 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

June 4, 2021

Last Update Submit

August 31, 2022

Conditions

Keywords

pregnancyfear of childbirthtokophobiaphysical activity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Healthy Pregnant

All volunteer pregnant women who were in the 2nd and 3rd trimesters (between 14-40 weeks) and who met the inclusion criteria in the study

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy pregnant women

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Maltepe, Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 10, 2021

Study Start

May 1, 2021

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations