- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750406
Effects of Mind Body Exercises in Pregnant Women
February 23, 2026 updated by: Riphah International University
Effects of Mind Body Exercises on Stress, Anxiety and Fatigue in Pregnant Women
his Study is a randomized controlled trial (RCT) which will be collected through non probability convenient sampling technique and will be carried out for 10 months duration with a sample size of 34 pregnant women which will be collected through non probability convenient sampling technique.
the participants will be divided into two groups.
Group A will be involved in mind body exercises and group B will be given relaxation exercises
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This Study is a randomized controlled trial (RCT) which will be collected through non probability convenient sampling technique and will be carried out for 10 months duration with a sample size of 34 pregnant women which will be collected through non probability convenient sampling technique.
Sample will be collected from Gosha shifa and Ishaq Haroon Hospital.
Pregnant women in their second trimester (between 14-28 weeks).
Age between 20 to 35 years.
Able to understand and participate in mind-body exercises sessions will be included.
High-risk pregnancies (e.g., gestational diabetes, hypertension).
Pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders).
will be excluded.
Tools used in the study are perceived stress scale (PSS) , Hamilton Anxiety Rating Scale (HARS) and Fatigue severity scale-(FSS).Data will be analyzed by busing SPSS 26.0
Study Type
Interventional
Enrollment (Actual)
34
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
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 6400
- Ishaq Haroon hospital and Goshea shifa hospital
-
-
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 in their second trimester (between 14-28 weeks)
- Primi gravid
- Able to understand and participate in mind-body exercises sessions
Exclusion Criteria:
- High-risk pregnancies (e.g., gestational diabetes, hypertension)
- Pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders)
- History of psychiatric disorders requiring ongoing treatment
- History of miscarriage
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mind body exercises
The intervention consists of a structured program of mind-body exercises designed specifically for pregnant women.
This involves a combination of yoga sessions, mindfulness meditation practices, deep breathing exercises, and progressive muscle relaxation techniques.
The duration of these sessions will be 45 to 60 minutes each, with a recommended frequency of 2-3 times per week for eight weeks
|
intervention might consist of a structured program of mind-body exercises designed specifically for pregnant women.
This could involve a combination of yoga sessions, mindfulness meditation practices, deep breathing exercises, and progressive muscle relaxation techniques.
The duration of these sessions will be 45 to 60 minutes each, with a recommended frequency of 2-3 times per week for 8 weeks
|
|
Active Comparator: Relaxation exercises
this includes Awareness about relaxation exercises including relax postures and generalized exercise interventions.
The duration of these sessions will be 45 to 60 minutes each, with a recommended frequency of 2-3 times per week for eight weeks
|
It involves relaxation exercises including deep breathing, relaxing postures etc.
The duration of these sessions will be 45 to 60 minutes each, with a recommended frequency of 2-3 times per week for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived- Stress Scale (PSS)
Time Frame: 8th week
|
The PSS has shown good internal consistency, with Cronbach's alpha coefficients typically ranging from 0.70 to 0.90.
Test-retest reliability over short intervals (e.g., a few days to a month) is generally acceptable, with correlation coefficients often above 0.70.The PSS correlates well with other measures of stress and related constructs, demonstrating good construct validity.
High PSS scores have been associated with increased risk for health problems and psychological issues, indicating good predictive validity
|
8th week
|
|
Hamilton Anxiety Rating Scale (HARS)
Time Frame: 8th week
|
The HARS has demonstrated good internal consistency, with Cronbach's alpha coefficients typically ranging from 0.74 to 0.96.
Inter-rater reliability is high, with intraclass correlation coefficients often above 0.80.
Test-retest reliability over periods of days to weeks is generally good, with correlation coefficients often above 0.75.The HARS covers a broad range of anxiety symptoms, ensuring good content validity.
It correlates well with other measures of anxiety and related constructs, demonstrating good construct validity.
The HARS scores are consistent with clinical diagnoses of anxiety disorders, indicating good concurrent validity
|
8th week
|
|
Fatigue Severity Scale (FSS)
Time Frame: 8th week
|
The FSS has shown excellent internal consistency, with Cronbach's alpha coefficients typically above 0.90.
Test-retest reliability over periods ranging from a few days to several weeks is generally high, with correlation coefficients often above 0.80.The FSS includes items that comprehensively cover the domain of fatigue, ensuring good content validity.
It correlates well with other measures of fatigue and related constructs, demonstrating good construct validity.
The FSS scores are consistent with clinical assessments of fatigue severity, indicating good concurrent validity
|
8th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hina gul, MSOMPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cheng YC, Su MI, Liu CW, Huang YC, Huang WL. Heart rate variability in patients with anxiety disorders: A systematic review and meta-analysis. Psychiatry Clin Neurosci. 2022 Jul;76(7):292-302. doi: 10.1111/pcn.13356. Epub 2022 Apr 27.
- Evans K, Spiby H, Morrell JC. Non-pharmacological interventions to reduce the symptoms of mild to moderate anxiety in pregnant women. A systematic review and narrative synthesis of women's views on the acceptability of and satisfaction with interventions. Arch Womens Ment Health. 2020 Feb;23(1):11-28. doi: 10.1007/s00737-018-0936-9. Epub 2019 Jan 7.
- Traylor CS, Johnson JD, Kimmel MC, Manuck TA. Effects of psychological stress on adverse pregnancy outcomes and nonpharmacologic approaches for reduction: an expert review. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100229. doi: 10.1016/j.ajogmf.2020.100229. Epub 2020 Sep 24.
- Nadholta P, Kumar K, Saha PK, Suri V, Singh A, Anand A. Mind-body practice as a primer to maintain psychological health among pregnant women-YOGESTA-a randomized controlled trial. Front Public Health. 2023 Sep 12;11:1201371. doi: 10.3389/fpubh.2023.1201371. eCollection 2023.
- Oyarzabal I, Zabala-Lekuona A, Mota AJ, Palacios MA, Rodriguez-Dieguez A, Lorusso G, Evangelisti M, Rodriguez-Esteban C, Brechin EK, Seco JM, Colacio E. Magneto-thermal properties and slow magnetic relaxation in Mn(II)Ln(III) complexes: influence of magnetic coupling on the magneto-caloric effect. Dalton Trans. 2022 Aug 30;51(34):12954-12967. doi: 10.1039/d2dt01869a.
- Guo P, Zhang X, Liu N, Wang J, Chen D, Sun W, Li P, Zhang W. Mind-body interventions on stress management in pregnant women: A systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2021 Jan;77(1):125-146. doi: 10.1111/jan.14588. Epub 2020 Oct 13.
- Lerdal A. Fatigue severity scale. Encyclopedia of quality of life and well-being research: Springer; 2021. p. 1-5.
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)
August 1, 2024
Primary Completion (Actual)
July 1, 2025
Study Completion (Actual)
August 1, 2025
Study Registration Dates
First Submitted
December 20, 2024
First Submitted That Met QC Criteria
December 20, 2024
First Posted (Actual)
December 27, 2024
Study Record Updates
Last Update Posted (Actual)
February 25, 2026
Last Update Submitted That Met QC Criteria
February 23, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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