Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 9:18 PM
Study NCT ID:
NCT05064657
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2021-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Two Method to Reducing Pain and Fear During Draw Blood From Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment First sub purpose was designed as parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wong Baker Pain Faces Scale mean score', 'timeFrame': 'First ten minute', 'description': 'Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient\'s pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 \'no pain) to a crying face (10 "worst pain"). 0 indicates no pain, 10 indicates the most severe pain. It defines the child\'s pain level before and after the blood collection.'}, {'measure': "Children's Fear Scale mean score", 'timeFrame': 'First ten minute', 'description': "Children's Fear Scale is a scale of 0-4 showing five faces ranging from a neutral expression (0 = no concern) to the feared face (4 = severe anxiety). A score of 0 indicates no fear and a score of 4 indicates extremely fearful. Defines the change of fear level before and after during the blood collection."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'procedural', 'fear', 'child', 'distraction methods'], 'conditions': ['Pain, Procedural', 'Pain Management', 'Child, Only']}, 'referencesModule': {'references': [{'pmid': '37984025', 'type': 'DERIVED', 'citation': 'Oluc N, Tas Arslan F. The effect of two different methods on reducing the pain and fear during phlebotomy to children: A randomized controlled trial. Int Emerg Nurs. 2024 Feb;72:101386. doi: 10.1016/j.ienj.2023.101386. Epub 2023 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate the effects of two different distraction methods on reducing pain and fear during blood collection from children.\n\nThe study was conducted between January 2020 and May 2021.', 'detailedDescription': "The study was a pretest-posttest, parallel group randomized controlled experimental design.\n\nH0: The pain and fear mean scores of the intervention group, in which the distraction method (ball squeezing and blowing bubbles) was applied during the blood collection process, was not different from the control group.\n\nThe study was carried out with the participation of 111 children aged 6-12 years and their parents, who underwent blood collection in the emergency department of a state hospital.\n\nChildren were randomly assigned to blowing bubbles (n:37), ball squeezing (n:37) and control (n:37) groups. Bubble blowing and ball squeezing methods were used to distract attention during the blood collection process. Data were collected with Child and Family Information Form, Wong Baker Faces Pain Scale, Child Fear Scale. Pretest and posttest measurements were recorded separately by the child, parent and researcher. Descriptive statistics, Chi-square test, one-way analysis of variance, Tamhane's T2 test, t test for dependent groups were used in the analysis of the data. The statistical significance of the results was taken as p\\<0,05"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being between the ages of 6-12\n* The child's willingness to voluntarily participate in the study\n* Parent's willingness to participate in the study voluntarily\n* Parent and child can speak Turkish\n\nExclusion Criteria:\n\n* The child has a disease that causes chronic pain\n* The child has a hearing or visual impairment\n* The child has a mental or neurological disability\n* The child has used drugs that will create an analgesic effect in the last 24 hours before the application"}, 'identificationModule': {'nctId': 'NCT05064657', 'briefTitle': 'The Effect of Two Method to Reducing Pain and Fear During Draw Blood From Children', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'The Effect of Two Different Applications on Reducing Pain and Fear During Draw Blood From Children', 'orgStudyIdInfo': {'id': 'SelcukU-01-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Experimental Group (ball squeezing) The group were used a ball squeezing method during the blood collection process.\n\nThe children were given a ball during the blood draw and told to tighten and loosen it.', 'interventionNames': ['Procedure: Bubble blowing method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': 'Active Comparator ( bubble blowing) The group were used a bubble blowing method during the blood collection process. During the blood collection process, the children were asked to blow bubbles by giving the apparatus inside the foam bubble to their free arm.', 'interventionNames': ['Procedure: Bubble blowing method']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No intervention'}], 'interventions': [{'name': 'Bubble blowing method', 'type': 'PROCEDURE', 'otherNames': ['Ball squeezing method'], 'description': 'The investigators were used "Bubble blowing method" and "ball squeezing method".\n\nTo child were used a ball squeezing method during the blood collection process.', 'armGroupLabels': ['Active Comparator', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42060', 'city': 'Konya', 'state': 'Selcuklu', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Fatma Tas Arslan, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Selcuk University'}, {'name': 'Neşe Oluç, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Selcuk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fatma Taş Arslan', 'investigatorAffiliation': 'Selcuk University'}}}}