Effects of Mind Body Exercises in Pregnant Women

NCT ID: NCT06750406

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pregnant women exercises yoga anxiety fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

mind body exercises

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

relaxation exercises

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mind body exercises

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

Intervention Type OTHER

relaxation exercises

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

hina gul, MSOMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ishaq Haroon hospital and Goshea shifa hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

imran amjad, PhD

Role: CONTACT

Phone: 03324390125

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

hina gul, MSOMPT

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 35340102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30613846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32995736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37766749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35960153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33048358 (View on PubMed)

Lerdal A. Fatigue severity scale. Encyclopedia of quality of life and well-being research: Springer; 2021. p. 1-5.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR&AHS/24/0529

Identifier Type: -

Identifier Source: org_study_id