Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05533827
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2022-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music 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']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-09-05', 'lastUpdatePostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain level', 'timeFrame': '5 minutes before intervention', 'description': 'Pain level'}, {'measure': 'Pain level', 'timeFrame': '5 minutes after intervention', 'description': 'Pain level'}, {'measure': 'Anxiety level', 'timeFrame': '5 minutes before intervention', 'description': 'Anxiety level'}, {'measure': 'Anxiety level', 'timeFrame': '5 minutes after intervention', 'description': 'Anxiety level'}, {'measure': 'Fear of medical procedures', 'timeFrame': '5 minutes before intervention', 'description': 'Fear of medical procedures'}, {'measure': 'Fear of medical procedures', 'timeFrame': '5 minutes after intervention', 'description': 'Fear of medical procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music', 'Kaleidoscope', 'virtual reality glasses'], 'conditions': ['Child Behavior']}, 'descriptionModule': {'briefSummary': 'This study was conducted on the effects of visual and/or auditory distraction techniques applied to children aged 7-12 years who applied to Çanakkale Mehmet Akif Ersoy State Hospital Gynecology and Pediatric Emergency Service during invasive procedures (blood sampling, intravenous access or intramuscular injection in the deltoid region). Kaleidoscope, music concert, virtual reality glasses) is a randomized controlled experimental study to determine the effect of children on pain, anxiety and fear of medical procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The child is between the ages of 7 and 12\n* Admission of the child to the pediatric emergency service for diagnosis and treatment\n* The child's general condition is stable\n* Deciding on one of the interventions such as blood collection, vascular access, deltoid region intramuscular injection after the examination, and the absence of any other invasive intervention planning\n* The fact that the invasive intervention was performed in one go\n* The child does not have vision and hearing problems\n* The child has no pain (due to the disease, drug side effects, distension)\n* The child does not have a chronic disease (kidney, diabetes, etc.) that will require frequent invasive procedures.\n* The child's mental development level to be able to answer the questions asked\n* The child and parent speak and understand Turkish comfortably\n* The children and their parents are willing to participate in the research.\n* Parents give written consent\n\nExclusion Criteria:\n\n* The child has a history of epilepsy, vertigo and neurological disease\n* Having a history of fainting during blood draw\n* Having a disease that causes chronic pain\n* Wearing glasses or hearing aids\n* Complication development during invasive intervention (allergy, syncope, etc.)\n* If the child is in danger of life and is taken to the very urgent patient examination room (resuscitation room)\n* Deciding that the child is a forensic case after the examination"}, 'identificationModule': {'nctId': 'NCT05533827', 'briefTitle': "The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions", 'organization': {'class': 'OTHER', 'fullName': 'Bandırma Onyedi Eylül University'}, 'officialTitle': "The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical", 'orgStudyIdInfo': {'id': 'BandirmaOnyediEylulUU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kaleidoscope', 'description': 'Kaleidoscope', 'interventionNames': ['Other: Kaleidoscope', 'Other: Music', 'Other: Virtual reality glasses']}, {'type': 'EXPERIMENTAL', 'label': 'Music', 'description': 'Music listening', 'interventionNames': ['Other: Kaleidoscope', 'Other: Music', 'Other: Virtual reality glasses']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual reality glasses', 'description': 'Virtual reality glasses', 'interventionNames': ['Other: Kaleidoscope', 'Other: Music', 'Other: Virtual reality glasses']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control'}], 'interventions': [{'name': 'Kaleidoscope', 'type': 'OTHER', 'description': 'Kaleidoscope', 'armGroupLabels': ['Kaleidoscope', 'Music', 'Virtual reality glasses']}, {'name': 'Music', 'type': 'OTHER', 'description': 'Music', 'armGroupLabels': ['Kaleidoscope', 'Music', 'Virtual reality glasses']}, {'name': 'Virtual reality glasses', 'type': 'OTHER', 'description': 'Virtual reality glasses', 'armGroupLabels': ['Kaleidoscope', 'Music', 'Virtual reality glasses']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bandırma', 'state': 'Balıkesir', 'country': 'Turkey (Türkiye)', 'facility': 'Banıdrma Onyedi Eylul University', 'geoPoint': {'lat': 40.35222, 'lon': 27.97667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bandırma Onyedi Eylül University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registered Nurse', 'investigatorFullName': 'Nursen Goktas', 'investigatorAffiliation': 'Bandırma Onyedi Eylül University'}}}}