Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06236867
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2023-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients did the pain scoring without knowing which group they were in. Patients are blinded.\n\nIn order to prevent the groups from being affected by each other, a inspection curtain was placed between the dialysis machines during the applications.\n\nThe data were coded as A, B and C groups and sent for statistical analysis. The outcomes assesor doing the analysis here is blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (Kaleidoscope application, ice application and control group).\n\nPatients were made to sign written voluntary consent forms by the researchers.After the patients were transferred to the randomized program for the arrival days and TC numbers for the dialysis session, they were assigned to the experimental and control groups.\n\nThe patients' pain levels were evaluated during 3 dialysis sessions. The pain level was evaluated without the procedure on the first day. 2 and 3. on the other hand, pain levels were evaluated after the interventions per day.\n\nThe data in the research are; Patient Diagnosis Form, Numerical Rating Scale and Life Signs Follow-up Form and Kaleidoscope Application Patient Experience Form, It was collected using the Patient Experience Form Related to Ice Application."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2023-12-27', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual pain scale (min-max:0-10 point) (1 week= during 3rd dialysis sessions)', 'timeFrame': 'One week= during 3rd dialysis sessions', 'description': "Evaluation of pain levels (minimum=0 points, maximum: 10 points) of experimental and control groups in the 1st, 2nd and 3rd dialysis sessions\n\nThe visual pain scale is minimum 0 and maximum 10 points. 0 means no pain, 10 means severe pain.\n\n1. st dialysis session= Visual analog pain scores during cannulation were evaluated without any application.\n2. nd and 3rd dialysis sessions: Ice application to the patient's hoku point was performed by the researcher for 1 min before the AVF cannulation procedure and during cannulation, and visual analog scale pain scores was filled in during cannulation.\n\nKaleidoscope application was performed to the patient for 5 minutes before AVF cannulation procedure and during cannulation. The visual analog scale pain score was filled in during cannulation.\n\nControl Group:visual analog scale pain scores will be evaluated before, during and after AVF cannulation without any intervention after the procedure."}], 'secondaryOutcomes': [{'measure': 'The evaluation of Ice Application and kaleidoscope application', 'timeFrame': 'After 3rd dialysis session (after one week)', 'description': 'Learning patient experiences regarding ice application and kaleidoscope application via Kaleidoscope Application Patient Experience Form, Patient Experience Form for Ice Application.\n\nThe answers of the participants to the questions in the evaluation forms (Kaleidoscope Application Patient Experience Form, Patient Experience Form for Ice Application) are presented as a percentage. They were asked to answer the questions asked in the form as "yes, no, partially".'}, {'measure': 'Sociodemographic and disease-related characteristics', 'timeFrame': 'through study completion, an average of 3rd month.', 'description': 'Comparison of sociodemographic characteristics (age, gender) with visual pain scale scores of the experimental and control groups.\n\nComparison of disease-related characteristics \\[Body mass index:weight and height will be combined to report BMI in kg/m\\^2 (weight in kilograms, height in meters=kg/m2), duration of dialysis (months), artery and vein needle size (14,15,16,17 gauge), duration of fistula use, region where the fistula is located)\\] with visual pain scale scores of the experimental and control groups.\n\nNOTE:After the data in all dialysis centers were completed (within about three months), the analysis was performed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arteriovenous fistula', 'Nursing', 'Pain Management'], 'conditions': ['Hemodialysis Access']}, 'descriptionModule': {'briefSummary': 'It was conducted to investigate the effect of ice application to the kaleidoscope and hoku point on the management of cannulization-related pain in patients receiving hemodialysis treatment.', 'detailedDescription': "After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (Kaleidoscope application, ice application and control group).\n\nPatients were made to sign written voluntary consent forms by the researchers.After the patients were transferred to the randomized program for the arrival days and TC numbers for the dialysis session, they were assigned to the experimental and control groups.\n\nThe patients' pain levels were evaluated during 3 dialysis sessions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Over age the 18', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nComfortable reception of trill and murmur sound from arteriovenous fistula,\n\n• over the age of 18 and no communication problems,\n\n* Having a place and time orientation,\n* No dizziness,\n\nExclusion Criteria:\n\n* Hemodialysis of the patient with arteriovenous graft and/or central venous catheter\n* Pharmacological application was made to relieve pain 30 minutes before AVF cannulation,\n\n * The patient has a COVID - 19 infection\n * Having visual, auditory and intellectual disabilities,\n * Having a communication problem,\n * Not willing and willing to participate in the study, as well as wanting to withdraw from the study at any stage of the study'}, 'identificationModule': {'nctId': 'NCT06236867', 'acronym': 'AVF', 'briefTitle': 'Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Amasya University'}, 'officialTitle': 'The Effect of Ice Application and Kaleidoscope Application on the Management of Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula', 'orgStudyIdInfo': {'id': 'AU-SBE-SY-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kaleidoscope Group', 'description': 'In order for the patients in the kaleidoscope group to recognize the device and increase their compliance during the procedure, a practice was performed using the device before the AVF cannulation procedure. Kaleidoscope application was performed during cannulation.', 'interventionNames': ['Other: KaleidoscopeGroup']}, {'type': 'EXPERIMENTAL', 'label': 'Ice Application Group', 'description': 'Ice application application was made with non-melting ice molds to the area where the index finger and thumb of the hand with fistula are joined (HOKU point).', 'interventionNames': ['Other: Ice Application Group']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'In the control group, the vital signs of the patients before AVF cannulation will be recorded. Before, during and after AVF cannulation, VAS pain scores will be evaluated after cannulation without any intervention.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'KaleidoscopeGroup', 'type': 'OTHER', 'otherNames': ['Experimental'], 'description': 'The group consists of 34 people. Pain level was measured during 3 dialysis sessions.In order for the patients in the kaleidoscope group to recognize the device and increase their compliance during the procedure, a practice was performed using the device before the AVF cannulation procedure. Kaleidoscope application was performed during cannulation.', 'armGroupLabels': ['Kaleidoscope Group']}, {'name': 'Ice Application Group', 'type': 'OTHER', 'otherNames': ['Experimental'], 'description': 'The group consists of 34 people. Pain level was measured during 3 dialysis sessions. Before, during and after AVF cannulation, VAS pain scores will be evaluated after cannulation without any intervention.Ice application application was made with non-melting ice molds to the area where the index finger and thumb of the hand with fistula are joined (HOKU point)', 'armGroupLabels': ['Ice Application Group']}, {'name': 'Control Group', 'type': 'OTHER', 'otherNames': ['Experimental'], 'description': 'The group consists of 34 people. Pain level will be measured during 3 dialysis sessions. In the control group, the vital signs of the patients before AVF cannulation will be recorded.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05100', 'city': 'Amasya', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Amasya University İnstitute of Health Sciences', 'geoPoint': {'lat': 40.65333, 'lon': 35.83306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The results will be shared when the author is requested for meta-analysis studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sülayman YAMAN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Master Student', 'investigatorFullName': 'Sülayman YAMAN', 'investigatorAffiliation': 'Amasya University'}}}}