NCT05129839

Brief Summary

The aim of this study is to present results on the effect of lightened and musical baby mobile on sleep quality in children hospitalized in the pediatric emergency clinic. In the randomized controlled study, 124 children hospitalized in the pediatric emergency clinic of a public hospital and appropriate the inclusion criteria were equally divided into 2 groups. The lightened and musical baby mobile was used during the night's sleep in the patient's room of the children in the first group (intervention group). The children in the second group (control group) did not use a lightened and musical baby mobile. The sleep quality of the children in the 2 groups was evaluated with the Child's Sleep Quality Evaluation Form (CSQEF).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

19 days

First QC Date

October 24, 2021

Last Update Submit

November 22, 2021

Conditions

Keywords

Pediatric emergency clinicSleepSleep qualityLightened and musical baby mobile

Outcome Measures

Primary Outcomes (1)

  • Identifying children's sleep quality

    The child's night sleep duration (hour and minute) and night awakenings (number) were evaluated.

    Change in the night sleep duration and night awakenings of children in two days.

Study Arms (2)

Lightened and Musical Baby Mobile Group

EXPERIMENTAL

The children in the study group were applied a lightened and musical baby mobile before sleeping at night.

Device: lightened and musical baby mobile

Control Group

NO INTERVENTION

The children in the control group were not given lightened and musical baby mobile, and their routine sleep patterns were continued.

Interventions

Before going to sleep in the infant's room in the intervention group, a lightened and musical baby mobile was used.

Lightened and Musical Baby Mobile Group

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Be between 1-3 years old
  • Being on the 2nd day of hospitalization
  • Staying with his mother in the emergency clinic for 24 hours
  • Parent's consent to participate in the study
  • Hospitalized due to an acute illness
  • Stable clinical condition
  • No painful intervention on the day of application
  • No isolation
  • Absence of neurological disease, mental and sensory disability

You may not qualify if:

  • A painful procedure on the day of application
  • Applying insulation
  • Neurological disease
  • Have a mental and sensory disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara Unıvesıty Educatıon And Research Hospıtal

Istanbul, Pendik, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Sinem Topsakal

    Marmara Unıvesıty Educatıon And Research Hospital Pediatric Emergency Clinic Istanbul, Turkey.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

October 24, 2021

First Posted

November 22, 2021

Study Start

September 1, 2019

Primary Completion

September 20, 2019

Study Completion

December 25, 2019

Last Updated

December 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations