- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07023978
- Original Trial
on General Well-being, Anxiety, and Physical Activity in Pregnant Women (Qigong)
August 2, 2025 updated by: Emine Dundar Ahi, MD, Kocaeli University
Effects of Qigong on General Well-being, Anxiety, and Physical Activity in Pregnant Women
102 pregnant women will be randomly divided into 2 groups.
Participants in the control group will be given pregnancy counseling that includes only nutrition, walking (3 days a week for 30 minutes), and breathing exercises, and will be called for 1st, 2nd and 3rd month check-ups.
In addition to pregnancy counseling, the Qigong group will receive 2 Qigong training sessions, one via Zoom and one face-to-face, and then the training videos of each exercise will be sent via WhatsApp.
Paricipants will be asked to do the Qigong exercises at home for 30 minutes, 3 days a week for 12 weeks.
These participants will be called for 1-month, 2-month and 3-month check-ups.
Blood pressure and sugar measurements will be recorded at the first visit, 1st month, 2nd month and 3rd month check-ups, and patients will also be evaluated with the Pregnancy Physical Activity Questionnaire, Pregnancy Stress Assessment Scale, Pregnancy-related Anxiety Scale, Pregnancy Exercise Self-Efficacy Questionnaire.
After the recruitment period the results will be evaluated statistically.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kocaeli, Turkey
- Home adress of the principal investigator
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pregnant women between the ages of 18-40 who have a new pregnancy detected by USG
- Pregnant women whose pregnancy week is compatible with fetal development, who do not have any problems and who will not have any problems exercising
Exclusion Criteria:
Those with risky pregnancies (cervical dilation, bleeding, premature membrane rupture, etc.) *<18 and >40 years old pregnant women
- Those with cardiovascular disease or hypertension
- Those with uncontrolled diabetes
- Those with uncontrolled thyroid disease
- Those with a previous risky pregnancy or a complication
- Those with an operation, metabolic bone disease or joint limitation that will prevent them from exercising
- Those who are included in another pregnancy counseling or physical activity program
- Those who do not give their consent for the study, do not come to regular pregnancy check-ups or have incomplete information will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: control arm
50 Pregnant women in the control group will be given pregnancy counseling that includes only nutrition, walking (3 days a week for 30 minutes), and breathing exercises, and will be called for 1st, 2nd and 3rd month check-ups.
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Active Comparator: Qigong arm
In addition to pregnancy counseling, the Qigong group will receive (52 participants) 2 Qigong training sessions, one via Zoom and one face-to-face, and then the training videos of each exercise will be sent via WhatsApp.
Patients will be asked to do the Qigong exercises at home for 30 minutes, 3 days a week for 12 weeks.
These patients will be called for 1-month, 2-month and 3-month check-ups.
|
Ba Duan Jin Qigong
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Glucose Values
Time Frame: 2 minutes
|
Glucose is the key metabolic substrate for tissue energy production.
In the perinatal period the mother supplies glucose to the fetus and for most of the gestational period the normal lower limit of fetal glucose concentration is around 3 mmol/L.
diabetes is high blood sugar (glucose) that develops during pregnancy and usually disappears after giving birth.
It can happen at any stage of pregnancy, but is more common in the second or third trimester.
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2 minutes
|
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blood pressure value
Time Frame: 2 minutes
|
High blood pressure during pregnancy occurs when a pregnant woman has a blood pressure reading of 140/90 mm Hg or higher in two readings that are 4 or more hours apart.
Severe high blood pressure during pregnancy occurs when a pregnant woman has a blood pressure reading of 160/110 mm Hg on two or more occasions
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2 minutes
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Pregnancy Exercise Self-Efficacy Scale
Time Frame: 10 minutes
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The Pregnancy Exercise Self-Efficacy Scale (P-ESES) is a validated tool designed to assess a pregnant woman's confidence in her ability to engage in physical activity during pregnancy.
It measures self-efficacy across various situations that may influence exercise behavior, such as fatigue, lack of time, or discomfort.
The scale typically includes a set of statements where respondents rate their confidence levels using a Likert-type scale (usually from 1 = not at all confident to 5 = completely confident).
Higher total scores indicate greater self-efficacy regarding exercise during pregnancy.
The final score is calculated by summing all item responses, and it helps identify women who may need additional support or encouragement to stay active.
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The 30-item Pregnancy Stress Rating Scale (PSRS)
Time Frame: 10 minutes
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The PSRS36 is a psychometrically sound and practical tool for nurses and other healthcare providers to assess prenatal stress and to examine intervention protocols in Taiwanese prenatal women.
More research is recommended to determine whether the PSRS36 may be used in other racial-ethnic groups.
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10 minutes
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Pregnancy-related anxiety scale
Time Frame: 10 minutes
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Pregnancy-related anxiety is a specific anxiety characterized by fears and worries about pregnancy.
This distinct anxiety is associated with various adverse neonatal (e.g., preterm birth), obstetric (e.g., prolonged and difficult labor), and maternal outcomes (e.g., mood disorders).
While several scales exist that assess pregnancy-related anxiety, there is limited information on their development and psychometric properties.
Moreover, general anxiety scales used to assess anxiety in pregnant women can confound assessment by the similarity of common pregnancy experiences with anxiety symptomology (e.g., poor sleep).
The development of the Pregnancy-related Anxiety Scale (PrAS) addressed this gap, and since its development, the PrAS has demonstrated sound psychometric properties.
To meet antenatal anxiety-screening guidelines that advocate using brief scales, the PrAS was refined to a 15-item version.
To
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10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2024
Primary Completion (Actual)
July 30, 2025
Study Completion (Estimated)
August 5, 2025
Study Registration Dates
First Submitted
June 1, 2025
First Submitted That Met QC Criteria
June 14, 2025
First Posted (Actual)
June 17, 2025
Study Record Updates
Last Update Posted (Actual)
August 7, 2025
Last Update Submitted That Met QC Criteria
August 2, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- KA24/178
- Emine Ahi (Other Identifier: Private clinic)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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