Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT07299058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was designed as a randomized controlled experimental trial. There will be one intervention group and one control group. The intervention and control groups will receive a pretest, followed by the planned interventions during the blood draw. The control group will receive routine care. Both groups will receive posttests after the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessment will be measured using a pain scale. The scale is scored from 0 to 10. The higher the score, the greater the pain.', 'timeFrame': 'Months 1-2 of the study'}, {'measure': 'Fear assessment will be measured using a fear scale. The scale is scored from 0 to 4. Higher scores indicate higher fear.', 'timeFrame': 'Months 1-2 of the study'}, {'measure': 'Emotional outlook assessment will be measured using the Emotional State Scale. The scale is scored from 5 to 25. Higher scores indicate higher negative emotional states.', 'timeFrame': 'Months 1-2 of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'fear', 'emotional state', 'children'], 'conditions': ['Pain', 'Blood Sampling Procedure', 'Fear Anxiety']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of a guessing game on fear, pain and emotional state during blood collection in children aged 6-12 years.', 'detailedDescription': 'Invasive medical procedures, particularly blood draws, are among the most common healthcare procedures in which children experience intense fear, pain, and emotional stress. The literature contains numerous studies on distraction interventions designed to improve children\'s psychological well-being and reduce the traumatic effects of these procedures. However, the majority of these studies have focused on passive distraction techniques (e.g., watching videos or listening to music), with less emphasis on play-based interventions that involve active child participation (Uman et al., 2013; Koller \\& Goldman, 2012). A meta-analysis by Birnie et al. (2018) demonstrated that distraction and techniques such as hypnosis are effective in reducing pain and anxiety associated with needle injections in children. Distraction-based approaches, in particular, have been reported to divert children\'s cognitive capacity from directing the procedure, leading to more positive emotional responses. A review of studies conducted in this area in Turkey reveals that methods such as distraction with music (Özdemir \\& Karakoç, 2017), blowing bubbles (Karaman \\& Selimen, 2015), and playing with toys have generally been evaluated. However, studies systematically examining play-based distraction practices that utilize children\'s cognitive functions such as decision-making, choice, and direction in the field of nursing are rare. A randomized controlled trial conducted by Hacettepe University found that a combination of information provision and an active distraction method (a tablet puzzle game) reduced both pain and fear levels in children (p=0.001-0.005) (Isıyel et al., 2023). Randomized controlled trials in the international literature demonstrate that playing video games, virtual reality, or using interactive technology (e.g., tablet games, VR modules) significantly reduces pain and anxiety during blood collection (Inan \\& Inal, 2019). \\| However, these studies often utilize passive or semi-passive distraction applications tailored to age, while predictive game designs that focus entirely on one-on-one interaction with the child are rarely featured in the literature. To this end, this study will evaluate the "Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 6 and 12 years of age\n* Not having a previous diagnosis of a serious hematological/psychiatric disease\n* The child and parent must be willing to participate in the study\n* Being able to speak and understand Turkish\n\nExclusion Criteria:\n\n* Having received sedation, analgesics, or anxiolytic medication during the procedure\n* Having a visual/hearing impairment\n* Having previously undergone an invasive procedure on the same day'}, 'identificationModule': {'nctId': 'NCT07299058', 'briefTitle': 'The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'The Effect of a Guessing Game on Fear, Pain, and Emotional State During Blood Collection in Children Aged 6-12', 'orgStudyIdInfo': {'id': 'DokuzEU-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: I Wonder What I Am Play']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group'}], 'interventions': [{'name': 'I Wonder What I Am Play', 'type': 'BEHAVIORAL', 'description': "I Wonder What I Am: This is a board game designed to help children over the age of four develop mental, cognitive, and language skills. The game consists of colorful cards with objects (animals, objects, vehicles, etc.) and a tool for placing them on the head. This tool begins with placing the object card to be guessed in the appropriate location, unseen by anyone else, and explaining the object's characteristics, followed by questions.", 'armGroupLabels': ['Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After the study is completed, it is planned to be shared in accordance with the permission given by the ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic staff', 'investigatorFullName': 'İlknur Bektaş', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}