Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT05997394
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2023-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The experimental and control groups will be determined by randomization method by a person other than the researcher. Participants will not know which group they are in.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'It is a semi-experimental type of study. It consists of two groups: experiment and control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dyspnea 12 scale', 'timeFrame': '1 month', 'description': 'as a result of 1-month prayer listening, the severity of dyspnea of the participants in the experimental group decreased. A minimum of 0 and a maximum of 36 points are taken from the scale. The increase in scores indicates that the frequency of dyspnea of patients has increased.'}, {'measure': 'Beck anxiety scale', 'timeFrame': '1 month', 'description': 'as a result of listening to prayer for 1 month, the anxiety severity of the participants in the experimental group decreased. A minimum of 0 and a maximum of 63 points are taken from the scale. The increase in scores indicates that the frequency of anxiety of patients has increased.'}, {'measure': 'Spiritual Well-Being Scale', 'timeFrame': '1 month', 'description': 'as a result of listening to prayer for 1 month, the spiritual well-being levels of the participants in the experimental group increased. A minimum of 0 and a maximum of 48 points are taken from the scale. An increase in scores indicates an increase in the spiritual well-being of patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DYSPNEA', 'SPIRITUAL GOODNESS', 'ANXIETY'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'This study will be conducted in order to examine the effect of prayer to individuals with COPD on the severity of dyspnea, anxiety and spiritual well-being experienced by patients.', 'detailedDescription': 'This study will be conducted on people with COPD. People with COPD disease will be divided into two groups. The experimental group will be given a prayer lesson for a month. Prayer listening will not be performed to the control group. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels of people in both groups will be re-evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 90 individuals (45 experiments, 45 controls) who can be contacted, who have agreed to participate in the study\n* who are literate, can speak Turkish\n* who have not participated in a similar application of this study before\n* who have agreed to participate in the study after being informed about the research\n* are 18 years old and over, with a COPD diagnosis will be taken\n\nExclusion Criteria:\n\n* Individuals with mental and hearing problems, who have lost a family member and someone close to them in the last year\n* who are using tranquilizers/antidepressants\n* who have experienced a traumatic situation such as divorce will be excluded from the sample.'}, 'identificationModule': {'nctId': 'NCT05997394', 'acronym': 'COPD', 'briefTitle': 'The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD', 'orgStudyIdInfo': {'id': 'SCU-SBF-GK-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Participants in this group will be given a prayer concert for a month. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels experienced by the participants will be re-checked.', 'interventionNames': ['Other: A prayer concert will be held for the participants.']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'There will be no prayer audience for participants in this group.'}], 'interventions': [{'name': 'A prayer concert will be held for the participants.', 'type': 'OTHER', 'description': 'Participants who are in the experimental group will be given a prayer audience.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Tokat Province', 'country': 'Turkey (Türkiye)', 'facility': 'Zile Devlet Hastanesi', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}], 'overallOfficials': [{'name': 'Gülden Kaygusuz Gülden Kaygusuz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tokat Zile Devlet Hatanesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not intended to share the data of individual participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Student', 'investigatorFullName': 'Gülden Kaygusuz', 'investigatorAffiliation': 'Cumhuriyet University'}}}}