Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT05695092
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2023-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Progressive Muscle Relaxation on Sleep Disturbance in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001326', 'term': 'Autogenic Training'}], 'ancestors': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'One group is taking actual intervention and other is taking sham interventioin'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-01-01', 'studyFirstSubmitQcDate': '2023-01-14', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'Baseline to after 24 hours', 'description': 'Sleep quality was measured with sleep disturbance score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disturbance in Athletes']}, 'descriptionModule': {'briefSummary': 'Literature supports that athletes have so many reasons for sleep disturbance in their day to day practice and during competition. This study is aimed to build familiarity with the significance of sleep for greatest athletic execution as well as providing Progressoive Muscle Relaxation(PMR),(A technique proposed by Jackobson to improve sleep and degrease the anxiety) as strategy to improve sleep prior to a significant competition during tournament', 'detailedDescription': "Adequate sleep is necessary to accomplish ideal athletic performance, cognitive functioning and overall well-being. Inadequate sleep is likewise connected to slow reaction time, delayed perception which can prompt impaired performance and increase risk of injury. A few investigations on sleep and athlete performance have additionally shown that sleep quality can be disturb for so many reasons.\n\nA range of interventions are available that may be beneficial or are commonly utilized in athletes to enhance sleep quantity and quality in athletes. Drug strategies and hypnotics are related with side effects, for example, drug resistance and withdrawal symptoms. Thus, there has been increase in utilization of non-drug strategies for further developing sleep quality. Among such strategies are relaxation methods. It has been considered as one of the cost effective and simple methods for easing sleep. Progressive Muscle Relaxation (PMR) is a method that involved efficiently relaxing global muscles of body with the objective of mental and physical relaxation. PMR is widely used previously to improve sleep in general population however there is currently no evidence to support PMR to improve sleep quality during a competition/tournament as a non-pharmacological method to improve participating athlete's sleep.\n\nThe aim of this study is to build familiarity with the significance of sleep for greatest athletic execution as well as providing PMR as strategy to improve sleep prior to a significant competition during tournament."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Participants falling in this category would be recruited into the study.\n\n* Active athletes who are training for a competition.\n* Age between 18 -36 years.\n* Athletes score falling above 4 on "Athletic Sleep Screening Questionnaire"\n\nExclusion Criteria:\n\nParticipant failing to fall in this category would be excluded of the study.\n\n* Athletes who are not performing for more than a year.\n* History of metabolic diseases.\n* Athletes taking sleeping aids i.e. sleeping pills.\n* Having acute injury'}, 'identificationModule': {'nctId': 'NCT05695092', 'briefTitle': 'Effectiveness of Progressive Muscle Relaxation on Sleep Disturbance in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effectiveness of Progressive Muscle Relaxation on Sleep Disturbance in Athletes', 'orgStudyIdInfo': {'id': '01380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'PMR session will be provided a night before competition', 'interventionNames': ['Behavioral: Progressive muscle relaxation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Simple ROM for upper limbs and lower limbs', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'Progressive muscle relaxation', 'type': 'BEHAVIORAL', 'otherNames': ['simple Range of Motion'], 'description': 'Progressive Muscle Relaxation (PMR): This method involved efficiently relaxing global muscles of body with the objective of mental and physical relaxation.', 'armGroupLabels': ['Experimental group']}, {'name': 'control', 'type': 'OTHER', 'description': 'control group will not receive any intervention', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Sports Complex', 'geoPoint': {'lat': 29.7426, 'lon': 73.14353}}], 'overallOfficials': [{'name': 'Professor Waqar Ahmed Awan, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FRAHS RIPHAH Islmabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Waqar Ahmed Awan', 'investigatorAffiliation': 'Riphah International University'}}}}