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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Kocaeli, Turkey
        • Home adress of the principal investigator

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other: Some movements in the qigong study called Ba Duan Jin, which will be applied to pregnant women, will be arranged for pregnant women and explained in detail. These are very slow, movements
Ba Duan Jin Qigong

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
2 minutes
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
2 minutes
Pregnancy Exercise Self-Efficacy Scale
Time Frame: 10 minutes
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.
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The 30-item Pregnancy Stress Rating Scale (PSRS)
Time Frame: 10 minutes
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.
10 minutes
Pregnancy-related anxiety scale
Time Frame: 10 minutes
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
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Pregnancy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings