on General Well-being, Anxiety, and Physical Activity in Pregnant Women

Not Applicable

Active, not recruiting

• Conditions: Pregnancy

• Registration Number: NCT07023978
• Lead Sponsor: Kocaeli University

Brief Summary

60 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-15
• Status Verified: 2025-06
• Primary Completion: 2025-06
• Study First Submitted: 2025-06-01
• Study First Submitted QC: 2025-06-14
• Last Update Submitted: 2025-06-14
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood Glucose Values	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.
Pregnancy Physical Activity Questionnaire,	10 minutes	is a widely available, self-administered semiquantitative questionnaire for the assessment of PA levels of pregnant women. There are 32 activities, including household/caregiving activities (13), occupational (5), sports/exercise (8), transportation (3), and sedentary activities (3). Participants were asked to select the category best estimating the amount of time spent on an activity per day or week during the current trimester for each activity. The duration ranged from 0 to 6 or more a day and from 0 to 3 or more a week during the current one month. At the end of the PPAQ, an open-ended section allowed the participant to add activities not already listed. From the PPAQ, the number of hours spent in each activity was multiplied by the activity intensity to arrive at a measure of average daily energy expenditure (MET-hours per day) attributable to each activity.
blood pressure value	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

Secondary Outcome Measures

Name	Time	Method
The 30-item Pregnancy Stress Rating Scale (PSRS)	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.
Pregnancy-related anxiety scale	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

Trial Locations

Locations (1)

Home adress of the principal investigator; 🇹🇷 Kocaeli, Turkey