Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-07 @ 1:42 PM
Study NCT ID:
NCT07005960
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of Art Therapy to Patients Undergoing Hemodialysis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001155', 'term': 'Art Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A total of 35 participants each for the experimental and for control groups will be randomly selected'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups, experimental group and control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State And Trait Anxiety Scale', 'timeFrame': '2 months', 'description': 'Measuring the change in Anxiety Levels through art therapy in patients undergoing hemodialysis treatment.'}, {'measure': 'Brief Psychological Resilience Scale', 'timeFrame': '2 months', 'description': 'Measuring the change in Psychological Resilience Levels through art therapy in patients undergoing hemodialysis treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Art therapy', 'Art therapy applied to hemodialysis patients', 'Anxiety and Psychological Well-Being'], 'conditions': ['Anxiety', 'Psychological Well-Being', 'Hemodialysis']}, 'descriptionModule': {'briefSummary': 'Purpose of the Study: This study aims to investigate the effect of art therapy on anxiety and psychological resilience levels in Chronic kidney disease(CKD) patients undergoing hemodialysis patients.\n\nHemodialysis patients undergo long-term treatment, often experiencing psychological issues such as anxiety and depression, which significantly reduce their quality of life. Among non-pharmacological approaches to alleviate these symptoms, art therapy has gained increasing attention. Art therapy helps patients shift their focus away from their illness, fosters self-confidence, reduces anxiety, and promotes relaxation .', 'detailedDescription': 'Preliminary Implementation of the Study Implementation of the Research During the data collection phase of the study, the researcher will explain the purpose of the study to patients who meet the inclusion criteria, provide necessary information, and obtain both verbal and written informed consent. After the information and consent process, all data in the "Personal Information Form" related to the patient will be filled out by the researcher.\n\nPatients will be divided into two groups: the experimental group (35 participants) and the control group (35 participants). Patients in the experimental group will be administered the Volunteer Information and Consent Form, the Patient Information Form, the Brief Resilience Scale, and the State-Trait Anxiety Inventory prior to the intervention.\n\nThen, for four weeks, the experimental group will participate in art therapy sessions involving drawing and painting for approximately 30 minutes, twice a week. In the first week, patients will be asked to paint a given picture. In the second week, they will be given a different picture to paint. In the third week, they will be asked to draw and paint a picture of their choice. In the fourth week, they will again be asked to draw and paint a picture of their choice. At the end of the fourth week, the scales will be completed again. By this point, each patient will have painted four given pictures and drawn and painted four of their own.\n\nAfter this, there will be a one-month break from art therapy, during which no intervention will be conducted. At the end of this month, the same scales will be administered again to the experimental group.\n\nFor the control group (35 participants), during the first week, without any intervention beyond standard clinical procedures, participants will complete the Volunteer Information and Consent Form, the Patient Information Form, the Brief Resilience Scale, and the State-Trait Anxiety Inventory. This process will be repeated in the fourth week. One month later, the same scales will be administered again without any intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nUndergoing hemodialysis for at least 6 months,\n\nWilling to participate in the study,\n\nAged between 18 and 65 years,\n\nNo communication disorders,\n\nNo infectious diseases.\n\nExclusion Criteria:\n\nSensory impairments (vision or hearing loss),\n\nNot willing to participate in the study,\n\nHaving an infectious disease.\n\nIndependent and Dependent Variables:\n\nIndependent Variable: Art therapy. Dependent Variables: Scores from the Brief Resilience Scale and State-Trait Anxiety Inventory (STAI 1-STAI 2).\n\nControl Variables: Participants' sociodemographic characteristics.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT07005960', 'briefTitle': 'The Application of Art Therapy to Patients Undergoing Hemodialysis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Cyprus Aydin University'}, 'officialTitle': 'The Effect of Art Therapy on Anxiety and Psychological Resilience in Patients Undergoing Hemodialysis Treatment', 'orgStudyIdInfo': {'id': 'CAU-LEAE-HEM-Eİ-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Art therapy experimental group', 'description': 'Patients in the experimental group will be administered the Volunteer Information and Consent Form, the Patient Information Form, the Brief Resilience Scale, and the State-Trait Anxiety Inventory prior to the intervention.', 'interventionNames': ['Other: Art Therapy for Anxiety in Hemodialysis Patients', 'Other: Art Therapy for Resilience in Hemodialysis Patients']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Art therapy control group', 'description': 'For the control group (35 participants), during the first week, without any intervention beyond standard clinical procedures, participants will complete the Volunteer Information and Consent Form, the Patient Information Form, the Brief Resilience Scale, and the State-Trait Anxiety Inventory. This process will be repeated in the fourth week. One month later, the same scales will be administered again without any intervention.', 'interventionNames': ['Other: Art Therapy for Anxiety in Hemodialysis Patients', 'Other: Art Therapy for Resilience in Hemodialysis Patients']}], 'interventions': [{'name': 'Art Therapy for Anxiety in Hemodialysis Patients', 'type': 'OTHER', 'description': 'Patients in the experimental group will be administered the Volunteer Information and Consent Form, the Patient Information Form, and the State-Trait Anxiety Inventory prior to the intervention.\n\nThen, for four weeks, the experimental group will participate in art therapy sessions involving drawing and painting for approximately 30 minutes, twice a week. In the first week, patients will be asked to paint a given picture. In the second week, they will be given a different picture to paint. In the third week, they will be asked to draw and paint a picture of their choice. In the fourth week, they will again be asked to draw and paint a picture of their choice. At the end of the fourth week, the scales will be completed again.\n\nAfter this, there will be a one-month break from art therapy, during which no intervention will be conducted. At the end of this month, the same scales will be administered again to the experimental group.', 'armGroupLabels': ['Art therapy control group', 'Art therapy experimental group']}, {'name': 'Art Therapy for Resilience in Hemodialysis Patients', 'type': 'OTHER', 'description': 'Patients in the experimental group will be administered the Volunteer Information and Consent Form, the Patient Information Form, the Brief Resilience Scale, prior to the intervention.\n\nThen, for four weeks, the experimental group will participate in art therapy sessions involving drawing and painting for approximately 30 minutes, twice a week. In the first week, patients will be asked to paint a given picture. In the second week, they will be given a different picture to paint. In the third week, they will be asked to draw and paint a picture of their choice. In the fourth week, they will again be asked to draw and paint a picture of their choice. At the end of the fourth week, the scales will be completed again.\n\nAfter this, there will be a one-month break from art therapy, during which no intervention will be conducted. At the end of this month, the same scales will be administered again to the experimental group.', 'armGroupLabels': ['Art therapy control group', 'Art therapy experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35930', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Berkay Head Nurse', 'role': 'CONTACT', 'phone': '05394836340'}], 'facility': 'Çeşme Alper Çizgenakat State Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'EMİNE İNAL', 'role': 'CONTACT', 'email': 'einal1973@hotmail.com', 'phone': '+905445730613'}], 'overallOfficials': [{'name': 'Sibel Olca POLAT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'sibelolca@aydın.edu.tr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMİNE İNAL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'EMİNE İNAL', 'investigatorAffiliation': 'Cyprus Aydin University'}}}}