Sleep Buddy Application in Hospitalized Children

April 2, 2026 updated by: aysel kokcudogan, Istanbul Medipol University Hospital

The Effect of Sleep Companion Application on Psychosocial Symptoms in Hospitalized Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Beykoz
      • Istanbul, Beykoz, Turkey (Türkiye), 34810
        • Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized school-age children (6-12 years old),
  • No mental disability,
  • Volunteer to participate in the research,
  • No allergies,
  • Children who are hospitalized for at least 3 days

Exclusion Criteria:

  • Hospitalized children under 6 years of age and over 12 years of age,
  • Predicted discharge in less than 3 days,
  • Children with a sleeping companion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep buddy
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.
Other: Sleep buddy
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.
No Intervention: control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial symptoms diagnostic scale
Time Frame: Used 3 days after the sleep companion app. The scale administration took 15 minutes.
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.
Used 3 days after the sleep companion app. The scale administration took 15 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Study Director: Aysel Kokcu Dogan, Ph.D, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-76728045-806.01.03-226794342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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