Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 5:34 PM
Study NCT ID:
NCT07493018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hand Puppet and Squeeze Toys on IV Placement in Pediatric Oncology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-03-20', 'studyFirstSubmitQcDate': '2026-03-20', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure duration', 'timeFrame': 'During procedure', 'description': 'Time from start to successful IV catheter placement.'}, {'measure': 'Number of IV catheter attempts:', 'timeFrame': 'During the IV procedure', 'description': 'Recorded for each peripheral IV catheter placement.'}], 'secondaryOutcomes': [{'measure': "Children's Fear Scale", 'timeFrame': 'Measured before and immediately after IV catheter placement', 'description': "A 5-point visual scale (0 = no fear, 4 = extreme fear) measuring children's anxiety and fear before and after the procedure. Applicable for children aged 5-10, can be completed by the child or observer."}, {'measure': "Children's Emotional Manifestation Scale", 'timeFrame': 'During procedure', 'description': 'Observational tool evaluating emotional responses during stressful medical procedures across five categories (facial expression, vocalization, activity, interaction, cooperation). Each category scored 1-5; total score 5-25, with higher scores indicating more negative emotional responses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Hematology', 'Pediatric Oncology']}, 'referencesModule': {'references': [{'pmid': '39002409', 'type': 'BACKGROUND', 'citation': 'Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2.'}, {'pmid': '39293201', 'type': 'BACKGROUND', 'citation': 'Gerceker GO, Bektas I, Yardimci F. The effects of virtual reality and stress ball distraction on procedure-related emotional appearance, pain, fear, and anxiety during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:197-204. doi: 10.1016/j.pedn.2024.08.029. Epub 2024 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigates hand puppet and squeeze toy techniques to reduce fear, emotional distress, and procedure time, and improve IV catheter placement success in 90 pediatric hematology-oncology patients (ages 6-10). Participants will be randomized into three groups: hand puppet, squeeze toy, or control. Outcomes include fear, emotional expression, procedure duration, number of attempts, and first-attempt success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren aged 6-10 years with a pediatric hematology or oncology diagnosis.\n\nCognitively able to understand instructions during the procedure.\n\nRequire peripheral IV catheter placement as determined by the healthcare team.\n\nDifficult Intravenous Access (DIVA) Score ≥4.\n\nChild and parent/guardian willing to participate.\n\nExclusion Criteria:\n\nPhysical condition preventing use of a squeeze toy.\n\nCognitive or developmental disorders preventing understanding of procedural instructions.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07493018', 'briefTitle': 'Effect of Hand Puppet and Squeeze Toys on IV Placement in Pediatric Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'The Effect of Hand Puppet and Squeeze Toy Techniques on Fear, Emotional Expression, and Procedure Success During Peripheral IV Catheter Placement in Pediatric Hematology-Oncology Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AkdenizUnOncology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hand Puppet', 'description': "In this arm, an independent researcher will use a hand puppet with child-friendly animal or profession-themed designs, moving it to music during IV catheter placement to engage the child's attention. The child selects the puppet and interacts with it while another researcher collects data. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration.", 'interventionNames': ['Other: Hand Puppet']}, {'type': 'EXPERIMENTAL', 'label': 'Squeeze Toy', 'description': 'Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention. This distraction aims to reduce fear, negative emotional responses, number of IV attempts, and procedure duration.', 'interventionNames': ['Other: Squeeze Toy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Children in the control group will receive standard peripheral IV catheter placement without any distraction techniques.'}], 'interventions': [{'name': 'Hand Puppet', 'type': 'OTHER', 'description': "Children interact with a hand puppet chosen according to their preference during IV catheter placement. The puppet's playful movements and music aim to distract and reduce fear and emotional distress.", 'armGroupLabels': ['Hand Puppet']}, {'name': 'Squeeze Toy', 'type': 'OTHER', 'description': 'Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention, reduces fear and distress, and helps them keep the procedure hand still. The toy is chosen by the child, hygienically managed, and given as a gift afterward. This simple, low-cost intervention aims to improve cooperation and IV placement success.', 'armGroupLabels': ['Squeeze Toy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Meltem Gürcan, PhD', 'role': 'CONTACT', 'email': 'meltemgurcan32@gmail.com', 'phone': '+90 506 508 6214'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Research Assistant', 'investigatorFullName': 'Meltem Gürcan', 'investigatorAffiliation': 'Akdeniz University'}}}}