Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 10:40 AM
Study NCT ID:
NCT05444634
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pain and Anxiety in Children With Intramuscular Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-07-02', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain, acute', 'timeFrame': '12 week', 'description': 'Wong Baker Faces Pain Rating Scale:\n\nThis scale was developed by Donna Wong and Connie Morain Baker in 1981 and later revised in 1983.\n\nThe scale is suitable for describing the pain status of children aged 3-18 years.\n\nChildren can express many pain areas and their severity with this scale. There are 6 facial expressions in the scale. The scores of "0", "2", "4", "6", "8", "10" were indicated for each facial expression, respectively.\n\nFacial expressions are given points with the lowest "0" and the highest "10". A score of "0" was defined as no pain, while a score of "10" was defined as unbearable pain.'}, {'measure': 'Anxiety, spitefulness', 'timeFrame': '12 week', 'description': 'Venham Anxiety Rating Picture Scale:\n\nThe scale was developed by Larry L. Venham and Elise Gaulin Kremer in 1979. The scale is used to determine the anxiety status of children over 3 years old. There are 8 cards in the scale and two pictures on each card. Cards 1 to 8 are shown to the child in turn.\n\nOf the pictures, the anxious picture is given 1 point, while the non-anxious picture is given 0 points.\n\nThe lowest is 0 points, while the highest is 8 points. In the 0 to 8 scoring system, the higher the score, the higher the anxiety rate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Pain, Acute', 'Anxiety'], 'conditions': ['Intramuscular Myxoma']}, 'descriptionModule': {'briefSummary': 'This study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection.', 'detailedDescription': 'Pharmacological and non-pharmacological methods are used in the management of pain and anxiety in children. Non-pharmacological methods are noninvasive, inexpensive, have no side effects and are independent functions of the nurse.This study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection. The study was conducted between May 2022 and August 2022. It will be done with children aged 3-6 years who come to the emergency unit of the State Hospital, who are given intramuscular injection.\n\n"Descriptive Information Form", "Wong Baker Faces Pain Rating Scale", "Venham Anxiety Rating Picture Scale" will be used in data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 3-6 years old\n* Intramuscular administration of ondansetron hcl active ingredient drug\n* Mentally and physically handicapped\n* Does not have a disease that causes chronic pain\n* Open to communication\n* Fluent in Turkish\n\nExclusion Criteria:\n\n* Children of parents who did not give written consent\n* Children who do not give verbal consent appropriate to the child's developmental level"}, 'identificationModule': {'nctId': 'NCT05444634', 'briefTitle': 'The Pain and Anxiety in Children With Intramuscular Injection', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of Distraction Cards and Stress Ball on Pain and Anxiety in Children With Intramuscular Injection', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.O.01.00/265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'distraction card', 'description': 'Immediately before the procedure, the child will be asked questions about the distraction cards. Questions about the cards will continue to be asked immediately after the intramuscular injection is finished.', 'interventionNames': ['Behavioral: Distraction Card']}, {'type': 'EXPERIMENTAL', 'label': 'Stress Ball', 'description': 'The child will be informed about the stress ball and asked to play continuously', 'interventionNames': ['Behavioral: Stress Ball']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Distraction Card', 'type': 'BEHAVIORAL', 'description': 'Suitable for children over 3 years old. 1 set of 32 pieces of thick cardboard cards It has been prepared by child development experts in line with pedagogical principles.\n\nSize: 13cm x 8cm, Each card illustrates the skills and actions the children do.', 'armGroupLabels': ['distraction card']}, {'name': 'Stress Ball', 'type': 'BEHAVIORAL', 'description': 'Brain Shaped Stress Ball, White rope in the form of mesh around the inner silicone Size: Approx 2.4 inches (6 cm), Color: Colorful, When squeezed, the silicone structure comes out in the mesh spaces and turns into a bunch of grapes.', 'armGroupLabels': ['Stress Ball']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'state': 'Erzuum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MSc Merve Eroğlu', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Türkan Kadiroğlu', 'investigatorAffiliation': 'Ataturk University'}}}}