Sleep Buddy Application in Hospitalized Children

NCT06508905 | Completed

• 1 other identifier: E-76728045-806.01.03-226794342
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Main Heading (Descriptor) Terms

Keywords

hospital; child; sleep companion; psychosocial symptoms

Outcome Measures

Primary Outcomes (1)

• Psychosocial symptoms diagnostic scale

  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.

Study Arms (2)

Sleep buddy

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Sleep buddy OTHER

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.

Sleep buddy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Study Officials

• Aysel Kokcu Dogan, Ph.D

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 18, 2024
• Study Start: July 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)