Fear of ChildbirthNCT04922346
The Relationship Between Physical Activity Level and Fear of Birth (Tokophobia) in Pregnant Women
An observational study of Fear of Childbirth, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of physical activity on fear of childbirth (tokophobia) in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Aug 2021
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the effects of physical activity on fear of childbirth (tokophobia) in pregnant women.
Read the detailed 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.
- Conditions
- Fear of Childbirth
- Keywords
- pregnancy, fear of childbirth, tokophobia, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 May 2021
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Omer Acar, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922346
- Sponsor's protocol ID
- E-18457941-050.99-10607
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2021
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Physical Activity Level and Fear of Birth (Tokophobia) in Pregnant Women
- ClinicalTrials.gov ID
- NCT04922346
- Acronym / sponsor ID
- E-18457941-050.99-10607
- Conditions
- Fear of Childbirth
- Keywords
- pregnancy, fear of childbirth, tokophobia, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 10 Jun 2021 (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.
The aim of this study is to determine the effects of physical activity on fear of childbirth (tokophobia) in pregnant women.
Detailed 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wijma Delivery Expectation/Experience Scale (W-DEQ)
Time frame: Baseline
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.
The Pregnancy Physical Activity Questionnaire
Time frame: Baseline
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.
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 1 Sep 2022.
- Individual participant dataSharing planned: No
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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 Fear of Childbirth, run by Marmara 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 1 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 1 Sep 2022. 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?
Wijma Delivery Expectation/Experience Scale (W-DEQ) (time frame: Baseline). The study lists 2 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 1 Sep 2022.