Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-30 @ 5:52 AM
Study NCT ID:
NCT06339866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The population of the research will be all patients who had adenotonsillectomy surgery between the ages of 6-12 in the Ear Nose and Throat Service of Zonguldak Bülent Ecevit University Hospital, and the sample will be all patients who had adenotonsillectomy surgery between the specified dates and who meet the inclusion criteria.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-30', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2024-03-24', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'After the intervention, the mean score of the children in the postoperative animation and cartoon group on the Wong Baker Pain Rating Scale will be lower than those in the control group.', 'timeFrame': '6 months', 'description': 'The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst." As the score increases, the child\'s pain improves.'}], 'secondaryOutcomes': [{'measure': "After the intervention, the mean score of the Children's Anxiety Scale-Stability score of the children in the postoperative animation and cartoon group will be less than those in the control group.", 'timeFrame': '6 months', 'description': 'The CASS is configured as a thermometer, including a bulb chamber at the bottom and horizontal lines upwards. Each horizontal line represents one score and the thermometer has 10 points. The bulb chamber at the bottom has 0 points and indicates no anxiety. As horizontal lines rise upwards, it is interpreted as an increase in anxiety. The highest score is 10, referring to the highest anxiety'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain,adenotonsillectomy,anxiety,children'], 'conditions': ['Pain After Adenotonsillectomy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32690314/', 'label': 'THE EFFECT OF A CARTOON AND AN INFORMATION VIDEO ABOUT INTRAVENOUS INSERTION ON PAIN AND FEAR IN CHILDREN AGED 6 TO 12 YEARS IN THE PEDIATRIC EMERGENCY UNIT: A RANDOMIZED CONTROLLED TRIAL'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the Research: The purpose of the research is to examine the effect of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.\n\nType of Research It is planned as a randomized controlled interventional type study to examine the effects of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.', 'detailedDescription': "Technology is an indispensable part of our age and daily life . When we look at the research, it is seen that educational interventional preparation programs increase the harmony between both children, parents and health professionals. The increase in children's self-control and the elimination of unrealistic expectations may be related to the trust in healthcare professionals. Studies indicate that educational video animations are the most effective non-pharmacological method in reducing anxiety . Video animations will be useful for children because they create sound and images. It is believed that video animations with educational content that are understandable to children are essential for children's education. It is believed that animation shown to children will reduce their anxiety."}, '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* Having adenotonsillectomy surgery\n* Signing the informed consent form by the patient's legal guardian\n\nExclusion Criteria:\n\n* Not being between the ages of 6-12\n* Not having adenotonsillectomy surgery\n* Failure to sign the enformel consent form by the patient's legal guardian"}, 'identificationModule': {'nctId': 'NCT06339866', 'briefTitle': 'The Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'E16734702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will follow the routine plan of the ward without any intervention planned.'}, {'type': 'EXPERIMENTAL', 'label': 'Educational animation group', 'description': "After the patients in this group arrive at the ward (after adenotonsillectomy), the Wong Baker pain scale and Child Anxiety Scale-Status (CAS-D) will be filled out by three observers (clinic nurse, parent and child) before the educational animated movie (before analgesic application) containing the surgical process at the 3rd hour (after adenotonsillectomy) and the animation will be watched behind it, and at the end, the same scales will be filled out again by three observers and the patient's pain and anxiety level will be evaluated.", 'interventionNames': ['Other: The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study']}, {'type': 'EXPERIMENTAL', 'label': 'Cartoon series group', 'description': 'In this group, the Wong Baker pain scale and Child Anxiety Scale-Disposition (CAS-D) will be filled out by three observers before watching cartoons at the 3rd hour post op (before analgesic administration), and the scales will be filled out again after the cartoon and anxiety and pain levels will be evaluated.', 'interventionNames': ['Other: The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study']}], 'interventions': [{'name': 'The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study', 'type': 'OTHER', 'description': 'The population of the study will be all patients who had adenotonsillectomy surgery between the ages of 6-12 in the Ear Nose and Throat Service of Zonguldak Bülent Ecevit University Hospital, and the sample will be all patients who had adenotonsillectomy surgery between the specified dates and who meet the inclusion criteria.', 'armGroupLabels': ['Cartoon series group', 'Educational animation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67600', 'city': 'Zonguldak', 'country': 'Turkey (Türkiye)', 'facility': 'Mihriye', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master student', 'investigatorFullName': 'mihriye koca', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}