Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-08 @ 3:31 AM
Study NCT ID:
NCT06508905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-03
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Buddy Application in Hospitalized Children
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': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychosocial symptoms diagnostic scale', 'timeFrame': 'Used 3 days after the sleep companion app. The scale administration took 15 minutes.', 'description': 'Determination of psychosocial symptoms of hospitalized children The highest score that can be obtained from the scale is "48" and the lowest score is "0". A high score on the scale means that the hospitalized school child has psychosocial problems.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hospital', 'child', 'sleep companion', 'psychosocial symptoms'], 'conditions': ['Main Heading (Descriptor) Terms']}, 'descriptionModule': {'briefSummary': 'The study was planned as a randomized controlled experimental study to investigate the effect of sleep companion application on psychosocial symptoms in hospitalized school children aged 6-12 years.', 'detailedDescription': 'The sample of the study consisted of a total of 97 school-age children hospitalized in the Pediatrics and Pediatric Surgery-Endocrine Service of the Health Services Application and Research Hospital of a university hospital and in the Pediatrics Service of a state hospital. Children who met the inclusion criteria and whose written and verbal consent was obtained from their parents for participation in the study after being informed were included in the study.\n\nThe study was completed as 50 control and 47 experimental group with 3 missing persons in the experimental group.\n\nData were collected using the "Introductory Information Form" and "Psychosocial Symptoms Diagnostic Scale for Hospitalized Children (PSDS)" tools.\n\nThe toy, which was selected as a sleep companion for the children in the experimental group, was introduced to the children and accompanied them for 3 days during their hospitalization. The experimental and control groups were observed for psychosocial symptoms.\n\nThe data will be analyzed with SPSS software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized school-age children (6-12 years old),\n* No mental disability,\n* Volunteer to participate in the research,\n* No allergies,\n* Children who are hospitalized for at least 3 days\n\nExclusion Criteria:\n\n* Hospitalized children under 6 years of age and over 12 years of age,\n* Predicted discharge in less than 3 days,\n* Children with a sleeping companion'}, 'identificationModule': {'nctId': 'NCT06508905', 'briefTitle': 'Sleep Buddy Application in Hospitalized Children', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effect of Sleep Companion Application on Psychosocial Symptoms in Hospitalized Children', 'orgStudyIdInfo': {'id': 'E-76728045-806.01.03-226794342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep buddy', 'description': 'Children who did not have their own sleeping companion were given a toy selected as a sleeping companion. The toy was introduced to the children and accompanied them for 3 days during their hospitalization.', 'interventionNames': ['Other: Sleep buddy']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'After the child in the control group was hospitalized in the clinic, routine hospitalization procedures were performed and no intervention was performed. The child was observed during the three days of hospitalization. It was observed that the children did not have their own toys with them.'}], 'interventions': [{'name': 'Sleep buddy', 'type': 'OTHER', 'description': 'The toy chosen as a sleep companion was introduced to the children in the experimental group and they were told that it would accompany them for 3 days during their hospitalization. Before giving the sleep companion, parents and children were informed about the sleep companion and their questions about the study were answered. Children who did not have their own sleep companion were included in the sample. The child was encouraged to sleep and spend time with the given sleep buddy and the family was also informed.', 'armGroupLabels': ['Sleep buddy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34810', 'city': 'Istanbul', 'state': 'Beykoz', 'country': 'Turkey (Türkiye)', 'facility': 'Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Aysel Kokcu Dogan, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'aysel kokcudogan', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}