Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-01-01 @ 6:03 AM
Study NCT ID:
NCT06750406
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mind Body Exercises in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived- Stress Scale (PSS)', 'timeFrame': '8th week', 'description': "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"}, {'measure': 'Hamilton Anxiety Rating Scale (HARS)', 'timeFrame': '8th week', 'description': "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"}, {'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': '8th week', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnant women', 'exercises', 'yoga', 'anxiety', 'fatigue'], 'conditions': ['Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '35340102', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30613846', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '32995736', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37766749', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35960153', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33048358', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Lerdal A. Fatigue severity scale. Encyclopedia of quality of life and well-being research: Springer; 2021. p. 1-5.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'pregnant females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women in their second trimester (between 14-28 weeks)\n* Primi gravid\n* Able to understand and participate in mind-body exercises sessions\n\nExclusion Criteria:\n\n* High-risk pregnancies (e.g., gestational diabetes, hypertension)\n* Pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders)\n* History of psychiatric disorders requiring ongoing treatment\n* History of miscarriage'}, 'identificationModule': {'nctId': 'NCT06750406', 'briefTitle': 'Effects of Mind Body Exercises in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Mind Body Exercises on Stress, Anxiety and Fatigue in Pregnant Women', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/24/0529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mind body exercises', 'description': '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', 'interventionNames': ['Other: mind body exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation exercises', 'description': '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', 'interventionNames': ['Other: relaxation exercises']}], 'interventions': [{'name': 'mind body exercises', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['mind body exercises']}, {'name': 'relaxation exercises', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Relaxation exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6400', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'hina gul, MSOMPT', 'role': 'CONTACT'}, {'name': 'Tseeba noor ata, MSPT(WH)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ishaq Haroon hospital and Goshea shifa hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'imran amjad, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}], 'overallOfficials': [{'name': 'hina gul, MSOMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}