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:
Istanbul Medipol University Hospital
Organization:
Study Overview
Official Title:
The Effect of Sleep Companion Application on Psychosocial Symptoms in Hospitalized Children
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
The study was completed as 50 control and 47 experimental group with 3 missing persons in the experimental group.
Data were collected using the "Introductory Information Form" and "Psychosocial Symptoms Diagnostic Scale for Hospitalized Children (PSDS)" tools.
The 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.
The data will be analyzed with SPSS software.
The study was completed as 50 control and 47 experimental group with 3 missing persons in the experimental group.
Data were collected using the "Introductory Information Form" and "Psychosocial Symptoms Diagnostic Scale for Hospitalized Children (PSDS)" tools.
The 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.
The data will be analyzed with SPSS software.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: