Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-28 @ 4:13 AM
Study NCT ID:
NCT06920095
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-09
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progressive Muscle Relaxation Exercises on Sleep, Fatigue, Pain in Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)', 'description': 'The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'After the intervention (After progressive muscle relaxation exercises applied in week 6)', 'description': 'The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.'}, {'measure': 'The Piper Fatigue Scale', 'timeFrame': 'Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)', 'description': 'It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items). Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints. Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.'}, {'measure': 'The Piper Fatigue Scale', 'timeFrame': 'After the intervention (After progressive muscle relaxation exercises applied in week 6)', 'description': 'It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items). Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints. Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)', 'description': 'The PSQI is a valid and consistent survey comprising 19 questions to assess the quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients\' subjective sleep quality, sleep delay, use of sleeping medication and dysfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score of ≤5 indicates "good sleep", and a score of\\>5 indicates "poor sleep"'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'After the intervention (After progressive muscle relaxation exercises applied in week 6)', 'description': 'The PSQI is a valid and consistent survey comprising 19 questions to assess the quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients\' subjective sleep quality, sleep delay, use of sleeping medication and dysfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score of ≤5 indicates "good sleep", and a score of\\>5 indicates "poor sleep"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma Patients']}, 'referencesModule': {'references': [{'pmid': '34785078', 'type': 'RESULT', 'citation': 'Loh EW, Shih HF, Lin CK, Huang TW. Effect of progressive muscle relaxation on postoperative pain, fatigue, and vital signs in patients with head and neck cancers: A randomized controlled trial. Patient Educ Couns. 2022 Jul;105(7):2151-2157. doi: 10.1016/j.pec.2021.10.034. Epub 2021 Nov 3.'}, {'pmid': '36332326', 'type': 'RESULT', 'citation': 'Tan L, Fang P, Cui J, Yu H, Yu L. Effects of progressive muscle relaxation on health-related outcomes in cancer patients: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2022 Nov;49:101676. doi: 10.1016/j.ctcp.2022.101676. Epub 2022 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'With regular practice, relaxation has been found to have many benefits such as reducing sensitivity to pain and fatigue, facilitating the transition to sleep, and improving quality of life. Therefore, this study was planned to examine the effects of progressive muscle relaxation exercises applied to lymphoma patients on sleep, fatigue, and pain.', 'detailedDescription': 'A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years of age\n* Being able to communicate adequately\n* Not having a psychiatric problem\n* Those who are determined by a physician to have no physical obstacle to exercise\n* Individuals who can use technological devices\n* Patients who have had at least 3 cycles\n\nExclusion Criteria:\n\n* Those with communication problems\n* Those with psychiatric problems\n* Patients doing any exercise\n* Individuals with phones that do not have a voice recording feature\n* Individuals with phones that do not have a WhatsApp feature'}, 'identificationModule': {'nctId': 'NCT06920095', 'briefTitle': 'Progressive Muscle Relaxation Exercises on Sleep, Fatigue, Pain in Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Sabahattin Zaim University'}, 'officialTitle': 'Effects of Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Lymphoma Patients', 'orgStudyIdInfo': {'id': '2025/01-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progressive muscle relaxation exercises', 'description': 'A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.', 'interventionNames': ['Other: Progressive muscle relaxation exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Routine maintenance will be applied'}], 'interventions': [{'name': 'Progressive muscle relaxation exercises', 'type': 'OTHER', 'description': 'A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.', 'armGroupLabels': ['Progressive muscle relaxation exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34034', 'city': 'Küçükçekmece', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Sabahattin Zaim University, Faculty of Health Sciences,', 'geoPoint': {'lat': 40.99104, 'lon': 28.77123}}], 'overallOfficials': [{'name': 'Zülfünaz Özer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İstanbul Sabahattin Zaim Üniversitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Nonre'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Sabahattin Zaim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Zülfünaz ÖZER', 'investigatorAffiliation': 'Istanbul Sabahattin Zaim University'}}}}