Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:45 AM
Study NCT ID:
NCT07443735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pinwheel and Bubble Blowing for Pain and Emotional Responses in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Pain Level", 'timeFrame': 'The scale will be administered and recorded by the researcher nurse during the procedure and 1 minute after the procedure is completed.', 'description': "Children's pain levels will be assessed using the Wong-Baker Faces Pain Scale. This scale consists of six facial expressions ranging from 0 (no pain) to 10 (worst pain). Children indicate their perceived pain intensity by selecting the face that best represents their pain."}], 'secondaryOutcomes': [{'measure': "Children's Emotional Status", 'timeFrame': 'The scale will be administered and recorded by the observer nurse immediately before the procedure, during venous blood sampling, and immediately after the procedure.', 'description': "Children's emotional responses will be assessed using the Children's Emotional Indicators Scale. The scale includes five parameters: facial expression, vocalization, activity, interaction, and cooperation. Each parameter is scored between 1 and 5, with total scores ranging from 5 to 25. Higher scores indicate more negative emotional responses. The scale will be applied by an observer nurse to evaluate children's emotional reactions such as fear, anxiety, and distress."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain and Emotional Responses in Children During Venous Blood Sampling']}, 'descriptionModule': {'briefSummary': "Venous blood sampling is one of the most frequently performed invasive procedures in children during diagnostic and treatment processes and may lead to pain, fear, and negative emotional responses. Such negative experiences in childhood may contribute to the development of anxiety toward healthcare services and reduced cooperation with healthcare professionals during treatment. Therefore, the use of non-pharmacological interventions aimed at reducing pain levels and emotional responses during procedures is of great importance in pediatric care.\n\nThe aim of this study is to determine the effects of pinwheel and bubble blowing techniques applied during venous blood sampling on pain levels and emotional states in children. This study will be conducted as a prospective, randomized controlled trial in the Blood Sampling Unit of the Pediatric Outpatient Clinic of a university hospital located in Edirne. A total of 66 children aged 3-6 years who will undergo venous blood sampling will be included in the study (pinwheel group: 22, bubble blowing group: 22, control group: 22).\n\nStudy data will be collected using the Child and Family Information Form, the Wong-Baker Faces Pain Rating Scale, and the Children's Emotional Indicators Scale. During venous blood sampling, pinwheel or bubble blowing techniques will be applied to the children in the experimental groups, while routine procedures will be performed for the children in the control group. The collected data will be analyzed using appropriate statistical methods. The results of this study are expected to contribute to the dissemination of evidence-based non-pharmacological practices aimed at reducing pain and emotional stress in pediatric nursing care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children aged 3-6 years\n* Willingness to undergo intravenous blood collection\n* Children's ability to apply distraction techniques during blood collection\n* No communication problems in children\n* No mental or neurological disability in the child\n* Venous blood collection performed in a single session\n* Parents and children must be willing to participate in the study\n\nExclusion Criteria:\n\n* Children not being between the ages of 3 and 6\n* Absence of intravenous blood collection request\n* Communication problems in children\n* Presence of mental or neurological disability in the child\n* Complaints that disrupt the child's comfort, such as pain, nausea, vomiting, etc., due to other reasons\n* Use of analgesic or sedative medication within 6 hours prior to the study\n* Absence of healthy skin integrity\n* Repeated attempts\n* Unexpected events occurring during blood collection\n* Parents or children not volunteering to participate in the study"}, 'identificationModule': {'nctId': 'NCT07443735', 'briefTitle': 'Pinwheel and Bubble Blowing for Pain and Emotional Responses in Children', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'The Effects of Pinwheel and Bubble Blowing on Pain and Emotional Responses in Children During Venous Blood Sampling', 'orgStudyIdInfo': {'id': 'TUTF-SBF-CE-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pinwheel Group', 'description': "Children aged 3-6 years undergoing venous blood sampling who receive pinwheel blowing in addition to standard care. Children's pain levels and emotional responses are evaluated.", 'interventionNames': ['Other: Pinwheel Group']}, {'type': 'EXPERIMENTAL', 'label': 'Bubble Blowing Group', 'description': "Children aged 3-6 years undergoing venous blood sampling who receive bubble blowing in addition to standard care. Children's pain levels and emotional responses are evaluated.", 'interventionNames': ['Other: Bubble Blowing Group']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care Group', 'description': "Children aged 3-6 years undergoing venous blood sampling who receive standard care only. Children's pain levels and emotional responses are evaluated."}], 'interventions': [{'name': 'Bubble Blowing Group', 'type': 'OTHER', 'description': 'The bubble blowing technique will be applied to randomly selected children during blood collection. Prior to the procedure, parents (mothers) will complete a "Child and Family Information Form," and the children\'s pain and emotional responses will be recorded by the researcher through observation using the Wong-Baker Pain Scale and the Emotional Indicators Scale (EIS).\n\n* During the intervention, children will be shown the bubble blowing technique and their attention will be diverted. Compliance with the intervention will be assessed based on the researcher\'s observations and parental feedback.\n* After the procedure, the same scales will be completed by the researcher, and changes in the children\'s pain and emotional states will be monitored.', 'armGroupLabels': ['Bubble Blowing Group']}, {'name': 'Pinwheel Group', 'type': 'OTHER', 'description': 'The pinwheel blowing technique will be applied to randomly selected children during blood collection. Before the procedure, parents (mothers) will fill out a "Child and Family Information Form," and the children\'s pain and emotional responses will be observed by the researcher using the Wong-Baker Facial Pain Scale and EIS.\n\n* The use of the pinwheel will be demonstrated during the intervention, and the children\'s attention will be diverted. Compliance with the intervention will be monitored through the researcher\'s observations and parental feedback.\n* After the procedure, the children\'s pain and emotional states will be recorded by the researcher using the same scales.', 'armGroupLabels': ['Pinwheel Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cansu Edi, Principal Investigator', 'role': 'CONTACT', 'email': 'cansuedi34@gmail.com', 'phone': '05452253790'}], 'overallOfficials': [{'name': 'Dr. Öğr. Üyesi Esra Nur KOCASLAN MUTLU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bağsız'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to ethical considerations and institutional data protection policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Öğr. Üyesi', 'investigatorFullName': 'Esra Nur Kocaaslan Mutlu', 'investigatorAffiliation': 'Trakya University'}}}}