Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04978805
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2021-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Progressive Relaxation Exercise and control group'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is an experimental study with pre-test and post-test contro'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '1. week', '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': '4. week', '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': '8. week', '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': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '1.week', 'description': 'The PSQI is a valid and consistent survey comprising of 19 questions to assess 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 disfunction 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 which is ≤5 indicates "good sleep", and a score which is \\>5 indicates "poor sleep"'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '4.week', 'description': 'The PSQI is a valid and consistent survey comprising of 19 questions to assess 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 disfunction 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 which is ≤5 indicates "good sleep", and a score which is \\>5 indicates "poor sleep"'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '8.week', 'description': 'The PSQI is a valid and consistent survey comprising of 19 questions to assess 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 disfunction 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 which is ≤5 indicates "good sleep", and a score which is \\>5 indicates "poor sleep"'}, {'measure': 'Modified Medical Research Council (mMRC)', 'timeFrame': '1.week', 'description': 'It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).'}, {'measure': 'Modified Medical Research Council (mMRC)', 'timeFrame': '4.week', 'description': 'It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).'}, {'measure': 'Modified Medical Research Council (mMRC)', 'timeFrame': '8.week', 'description': 'It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer patients', 'Pain', 'Sleep quality', 'Progressive Relaxation Exercise'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '29281868', 'type': 'BACKGROUND', 'citation': 'Borji M, Nourmohammadi H, Otaghi M, Salimi AH, Tarjoman A. Positive Effects of Cognitive Behavioral Therapy on Depression, Anxiety and Stress of Family Caregivers of Patients with Prostate Cancer: A Randomized Clinical Trial. Asian Pac J Cancer Prev. 2017 Dec 28;18(12):3207-3212. doi: 10.22034/APJCP.2017.18.12.3207.'}, {'pmid': '28069156', 'type': 'BACKGROUND', 'citation': 'Tsitsi T, Charalambous A, Papastavrou E, Raftopoulos V. Effectiveness of a relaxation intervention (progressive muscle relaxation and guided imagery techniques) to reduce anxiety and improve mood of parents of hospitalized children with malignancies: A randomized controlled trial in Republic of Cyprus and Greece. Eur J Oncol Nurs. 2017 Feb;26:9-18. doi: 10.1016/j.ejon.2016.10.007. Epub 2016 Nov 18.'}, {'pmid': '38636116', 'type': 'DERIVED', 'citation': 'Turan GB, Ozer Z, Sarikose A. The effects of progressive muscle relaxation exercise applied to lung cancer patients receiving chemotherapy on dyspnea, pain and sleep quality: A randomized controlled trial. Eur J Oncol Nurs. 2024 Jun;70:102580. doi: 10.1016/j.ejon.2024.102580. Epub 2024 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'This study was planned to examine the effect of progressive relaxation exercises applied to lung cancer patients receiving chemotherapy on dyspnea, pain and sleep quality.', 'detailedDescription': 'It is thought that relaxation exercises reduce respiratory distress and improve sleep quality in lung cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between the ages of 18-65\n* Ability to communicate adequately\n* Absence of psychiatric problems\n* Those who are determined by the physician that they do not have a physical disability in exercising\n* Volunteering to participate in the research\n* Individuals who have the ability to use technological tools\n* Patients with at least 3 cures\n\nExclusion Criteria:\n\n* Individuals with phones that do not have voice recording capabilities\n* Individuals with phones that do not have the ability to install Whatsapp'}, 'identificationModule': {'nctId': 'NCT04978805', 'acronym': 'Progressive', 'briefTitle': 'Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Sabahattin Zaim University'}, 'officialTitle': 'The Effect of Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality in Lung Cancer Patients Receiving Chemotherapy', 'orgStudyIdInfo': {'id': '2021/03 - 27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progressive Relaxation Exercise', 'description': 'A total of 56 sessions of progressive relaxation were performed, 7 days a week for 8 weeks. Each session is set as fifty minutes', 'interventionNames': ['Behavioral: Progressive Relaxation Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Routine maintenance will be applied'}], 'interventions': [{'name': 'Progressive Relaxation Exercise', 'type': 'BEHAVIORAL', 'description': 'In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.', 'armGroupLabels': ['Progressive Relaxation Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'state': 'State', 'country': 'Turkey (Türkiye)', 'facility': 'Zülfünaz', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Sabahattin Zaim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD., Assistant Prof', 'investigatorFullName': 'Zülfünaz ÖZER', 'investigatorAffiliation': 'Istanbul Sabahattin Zaim University'}}}}