Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:15 AM
Study NCT ID:
NCT07430995
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Storybooks and Hand Puppets to Reduce Fear in Children Undergoing Day Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Surgical procedures were scheduled for wednesdays and fridays. Therefore, the research was conducted on wednesdays and fridays. Wednesday was puppet day and Thursday was storybook day. Consequently, "Due to the nature of the interventions (storybooks=33 and hand puppets=33), participants were completely blinded to the assigned group. However, the research practitioner was dominant in the process, and the nurse was blinded to the study\'s baseline hypotheses. Furthermore, during the statistical evaluation phase, the other researcher was blinded to group assignments to prevent bias and was not involved in the data collection process." After the experimental groups reached the desired number, control groups =33 were collected.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Fear Scale (CFS) Score', 'timeFrame': '"Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room)."', 'description': "The CFS is a self-report scale consisting of five faces ranging from a neutral expression (0 - no fear) to a frightened expression (4 - extreme fear). It is used to measure the child's subjective level of fear."}, {'measure': "Children's Emotional Manifestation Scale (CEMS) Score", 'timeFrame': 'Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room).', 'description': 'An observational scale consisting of 5 categories (facial expression, vocalization, activity, interaction, and cooperation). Each category is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher emotional distress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Surgery', 'Preoperative Fear', 'Distraction Techniques', 'Storytelling', 'Puppetry', 'Emotional Responses', 'Nursing Care'], 'conditions': ['Preoperative Fear', 'Emotional Distress']}, 'descriptionModule': {'briefSummary': "Summary The aim of this study is to see if storybooks or hand puppets help reduce fear in children before outpatient surgery. Researchers want to find out which of these two methods works better to help children feel calmer and less upset.\n\nWhy is this study being conducted? Going into surgery can be frightening for children. This research is looking for simple and fun ways to reduce a child's fear without using medication.\n\nHow will the research be conducted?\n\nThe study included 99 children (ages 4-7) undergoing outpatient surgery. The children were divided into three equal groups:\n\nGroup 1 (Control): Received standard hospital care.\n\nGroup 2 (Storybook): Read an educational book about a character going into surgery.\n\nGroup 3 (Puppet): Played with a hand puppet before the procedure.\n\nResearchers measured the children's fear and emotional responses twice: approximately 1 hour before surgery and immediately before entering the operating room. By comparing these scores, the study shows whether it was the storybook or the puppet that helped the children feel better.", 'detailedDescription': 'The aim of this randomized controlled trial is to evaluate and compare the effectiveness of two different non-pharmacological distraction methods-educational storybooks and hand puppets-on preoperative fear and emotional manifestations in children undergoing day case surgery.\n\nMethodology:\n\nThe study was conducted with 99 children, aged 4 to 7, who met the inclusion criteria. Participants were randomly assigned to one of three groups using a 1:1:1 allocation ratio:\n\nControl Group (n=33): Received standard preoperative nursing care, including routine information provided by the hospital staff.\n\nStorybook Group (n=33): In addition to standard care, children were read an educational storybook titled "Elif Ameliyat Oluyor" (Elif is Having Surgery). The book describes the surgical process through a child\'s perspective to familiarize them with the environment.\n\nHand Puppet Group (n=33): In addition to standard care, a researcher engaged the child in interactive play using a hand puppet. The puppet was used to simulate the medical procedures in a non-threatening and playful manner.\n\nData Collection and Outcome Measures:\n\nTwo primary tools were used to collect data:\n\nChild Fear Scale (CFS): A self-report scale used to assess the child\'s level of fear.\n\nChildren\'s Emotional Manifestation Scale (CEMS): An observational scale used by researchers to record behaviors such as crying, facial expressions, and cooperation.\n\nData were collected at two specific time points:\n\nT1 (Baseline): Approximately 1 hour before the surgical procedure (pre-intervention).\n\nT2 (Final): Immediately before the child was transferred to the operating room (post-intervention).\n\nThe study seeks to determine whether these distraction techniques significantly lower fear scores compared to standard care and which method is more effective in a clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 4 and 7 years.\n* Children hospitalized in the pediatric surgery ward.\n* Scheduled for elective (planned) surgery.\n* Ability to understand and speak Turkish.\n* Willingness of both the child and a parent/legal guardian to participate in the study.\n\nExclusion Criteria\n\n* Children with long-term hospitalization history.\n* Participants who received analgesic or sedative medication within the last 24 hours.\n* Presence of major trauma, chronic disease, or chronic pain conditions requiring rapid assessment.\n* Any physical or cognitive impairment that hinders effective communication (e.g., significant visual, hearing, or speech impairments).\n* Presence of diagnosed mental or developmental disabilities.\n* History of psychiatric disorders such as Attention Deficit Hyperactivity Disorder (ADHD).\n* Participants or parents who wish to withdraw from the study at any stage.'}, 'identificationModule': {'nctId': 'NCT07430995', 'briefTitle': 'Comparing Storybooks and Hand Puppets to Reduce Fear in Children Undergoing Day Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Muş Alparslan University'}, 'officialTitle': "The Effect of Two Different Distraction Methods Applied Before Day Case Surgery on Children's Fear and Emotional Indicators: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '13.11.2024-167632'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Storybook Group', 'description': 'Prior to the intervention, participants were read an educational storybook titled "Elif is Having Surgery" by a researcher. The intervention focused on introducing the child to the surgical process through storytelling.', 'interventionNames': ['Behavioral: Storybook Group']}, {'type': 'EXPERIMENTAL', 'label': 'Hand Puppet Group', 'description': 'Participants engaged in pre-intervention interactive play with a hand puppet under the guidance of a researcher. The puppet recorded the treatment process to simulate the treatment and provide emotional support through play.', 'interventionNames': ['Behavioral: Hand Puppet Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in this group received only the standard preoperative nursing care provided by the hospital, with no additional distraction methods.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Storybook Group', 'type': 'BEHAVIORAL', 'description': 'Participants completed an information form immediately after being admitted to the clinic in the morning. Then, a researcher read an educational storybook titled "Elif is Having Surgery." The intervention aimed to focus the child\'s attention on the surgical process through storytelling. Following this, a form was administered to measure fear and emotional indicators. One hour later, before the patient donned the surgical gown and left the room for surgery, the same story was read to the group again.', 'armGroupLabels': ['Storybook Group']}, {'name': 'Hand Puppet Group', 'type': 'BEHAVIORAL', 'description': 'Participants completed an introductory information form immediately after being admitted to the clinic in the morning. Then, a researcher used gender-specific felt hand puppets to help children integrate into the hospital environment, facilitate their adaptation to preoperative preparation, and reduce preoperative fear and negative emotional indicators. A form to measure fear and emotional indicators was then administered. One hour later, before the patient donned their surgical gown and left the room for surgery, the same puppet procedure was repeated for this group.', 'armGroupLabels': ['Hand Puppet Group']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Participants completed an introductory information form immediately after being admitted to the clinic in the morning. Then, clinic nurses provided information about the routine procedure to prepare them for the operation. Following this, a form was administered to measure fear and emotional indicators. One hour later, before the patient donned the surgical gown and left the room for surgery, the same procedure was repeated to this group.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Muş', 'state': 'Province', 'country': 'Turkey (Türkiye)', 'facility': 'Mus State Hospital, Pediatric Surgery Department', 'geoPoint': {'lat': 38.73163, 'lon': 41.48482}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) will be shared in de-identified form upon reasonable request to the Principal Investigator. Data will be available after publication of the main results and will be provided only for research purposes with appropriate ethical approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muş Alparslan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emine Beyaz', 'investigatorAffiliation': 'Muş Alparslan University'}}}}