Sleep Buddy Application in Hospitalized Children

NCT ID: NCT06508905

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-10-30

Brief Summary

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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

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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.

Conditions

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Main Heading (Descriptor) Terms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep buddy

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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aysel kokcudogan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysel Kokcu Dogan, Ph.D

Role: STUDY_DIRECTOR

Medipol University

Locations

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Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-76728045-806.01.03-226794342

Identifier Type: -

Identifier Source: org_study_id

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