Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-28 @ 10:44 AM
Study NCT ID:
NCT04690257
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2020-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2020-12-26', 'studyFirstSubmitQcDate': '2020-12-26', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain and anxiety measured by parents and observe.', 'timeFrame': 'Immediately after venipuncture (1-2 min.)', 'description': 'Visual Analog Scale (VAS) was used to measure the pain and fear of children by parents and observer. A rating of 0 represents no pain and 10 represents the worst or most severe pain. The VAS is a valid, reliable, and frequently used measure of procedural distress in children 6 to 18 years of age.'}], 'primaryOutcomes': [{'measure': 'Pain Intensity Measure', 'timeFrame': 'Immediately after venipuncture (1-2 min)', 'description': 'Wong-Baker faces scale (WBFS). Used to measure the pain severity during the procedure, the WB-FBRS is a series of six cartoon faces positioned side-by-side from the greatest pain to the mildest one (0-5).'}], 'secondaryOutcomes': [{'measure': 'Fear Measure', 'timeFrame': 'Immediately after venipuncture (1-2 min. )', 'description': "The Childrens Fear Scale (CFS) is used to assess children's fear or anxiety levels. The one-item scale consists of five sex neutral faces arranged from left to right with no fear in the center, through fear out to extreme fear."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venipuncture', 'Pain', 'Anxiety', 'Fear']}, 'referencesModule': {'references': [{'pmid': '35512482', 'type': 'DERIVED', 'citation': "Suleman SK, Atrushi A, Enskar K. Effectiveness of art-based distraction on reducing pediatric patients' pain and anxiety during venipuncture: A randomized controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101597. doi: 10.1016/j.ctcp.2022.101597. Epub 2022 Apr 30."}]}, 'descriptionModule': {'briefSummary': "Venipuncture is one of the most common stressful procedures in children. Managing pain and fear of venipuncture procedure recommended strongly because it may change children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses.\n\nThere was clear evidence that the distraction method is the most performed as a psychological technique performed to decrease venipuncture-related pain and distress and supporting its efficacy in children.\n\nThe aim of this study to investigate the effectiveness of TICK-B on children's pain and anxiety during venipuncture procedure.", 'detailedDescription': 'Note:\n\nThe first registration number for the protocol of Ph.D. was approved as 10092019-6 on 10th September 2019 It approved the grant to publish the result as 20072020-3 on 23, August,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being between 6-12 years old,\n* a physician order was placed for the blood sample,\n\nExclusion Criteria:\n\n* Chronic medical condition.\n* Those whose parent not participated,\n* Neurodevelopmental delayed, verbal difficulties, difficulties in hearing or visual,\n* Unconsciousness.\n* Take a medication analgesic in the past 6 hrs.\n* history of syncope.'}, 'identificationModule': {'nctId': 'NCT04690257', 'briefTitle': 'Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture', 'organization': {'class': 'OTHER', 'fullName': 'University of Witten/Herdecke'}, 'officialTitle': 'The Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture in a Pediatric Department: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SSKhudeida'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TICK-B group as Intervention group', 'description': 'Experimental: TICK-B group\n\n-Pediatric patients received TICK-B as a distraction in the TICK-B group', 'interventionNames': ['Other: Trace Image and Coloring for Kids-Book (TICK-B)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care provided group as control group', 'description': '-Pediatric patients received standard care (routine care) in the control group.'}], 'interventions': [{'name': 'Trace Image and Coloring for Kids-Book (TICK-B)', 'type': 'OTHER', 'description': 'A collection of pictures designed as a book contains and given to children during the procedure and they take a picture as they favored.', 'armGroupLabels': ['TICK-B group as Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58455', 'city': 'Witten', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Sherzad Suleman', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}], 'overallOfficials': [{'name': 'Akram M Atrushi, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Duhok University'}, {'name': 'Margareta Halek, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Witten\\Herdecke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Witten/Herdecke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator (PhD Student)', 'investigatorFullName': 'Sherzad Khudeida Suleman', 'investigatorAffiliation': 'University of Witten/Herdecke'}}}}