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SleepNCT05129839

Use of Lightened and Musical Baby Mobile in a Pediatric Emergency Clinic

A study testing lightened and musical baby mobile in people with Sleep and Nursing Caries, run by Maltepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 year to 3 years
Conditions the study is for
Sleep, Nursing Caries
What is being tested?
lightened and musical baby mobile
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2019to 25 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 3 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
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  • No painful intervention on the day of application
  • No isolation
  • Absence of neurological disease, mental and sensory disability

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara Unıvesıty Educatıon And Research Hospıtal

    Istanbul, Pendik

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Lightened and Musical Baby Mobile on Sleep Quality in Hospitalized Children in A Pediatric Emergency Clinic: A Prospective Randomized Controlled Study

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).

Read the detailed description

Illness, hospital environment, hospitalization and routines; are common sources of stress experienced by children. This experience; delays the child's recovery process and growth-development, impairs play activity and sleep quality. The aim of this randomized controlled 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.

METHODS This study was conducted in a single-center, prospective randomized controlled design. The sample size of the study was calculated in the program of G* Power 3.1.9.2 (Heinrich Heine University Düsseldorf, Germany). The sample size was found to be 60 children for each group. The study authors considered possible sample losses during the study process. It was decided to conduct the study with a total of 124 children. There were 62 children in each group (intervention and control group). This study included 150 children hospitalized in a 6-bed pediatric emergency clinic of a public hospital in Istanbul between October and December 2019. Of these children, 124 children who met the inclusion criteria were included in the study. Children who were transferred to other inpatient units after hospitalization in the emergency department (n=18) and whose parents refused to participate in the study (n=8) were excluded from the study.

Procedures:

Assigning the participants to the groups, positioning and operating the lightened and musical baby mobile in the child's room, taking vital signs, collecting the data in the CSQEF and all recordings were made by the first researcher. The first researcher has 5 years of experience as a pediatric emergency nurse. In the pediatric emergency clinic, nurses work in 2 shifts (08:00-17:00 and 16:00-08:00). The first investigator works in the pediatric emergency clinic. In this study, the following procedure was applied, respectively. Each child admitted to the pediatric emergency clinic was taken to the patient's room with his mother, his clinical status was evaluated, and the children to be included in the intervention and control groups were determined. Parents of the children included in the intervention group were informed about all stages of the research process, and their verbal and written consents were obtained. Assignment of children to groups was done by simple randomization method (according to their hospitalization on odd and even number days of the calendar). Children who were hospitalized on odd-numbered days of the calendar were included in the intervention group, and children hospitalized on even-numbered days were included in the control group. For example; The child admitted to the pediatric emergency clinic on October 11 was included in the intervention group, and the child hospitalized on October 12 was included in the control group. This sequence was repeated until the number of samples was completed. In this study, all assessments were made in the same way for the children in the intervention and control groups. In this study, data on children's sleep quality and vitals signs were re-evaluated in different time periods. These time periods are: pre-intervention and intervention day. Intervention day; in the morning (at 08:00), before going to sleep (at 20:00), during sleep (at 02:00), and the next morning (at 08:00). Before the intervention; It covers between at 08:00 in the morning the day before the child is admitted to the emergency clinic and at 08:00 in the morning on the day the child is admitted to the emergency clinic. Intervention day; It covers the first day of the child's admission to the emergency clinic between at 08:00 in the morning and at 08:00 in the next day. Factors defining the sleep quality of children; It was evaluated twice, before the intervention and on the day of the intervention. Children's vital signs, intervention day; It was measured 4 times ( in the morning, before going to sleep, during sleep and the next morning), using a pulse oximetry device and an infrared thermometer. All data, except the vital signs of the children, were asked to the mothers face-to-face and their answers were recorded in the CSQEF.

Instruments:

Data were collected with the Child's Sleep Quality Evaluation Form (CSQEF). CSQEF was developed by the authors based on the literature. The questions in the form; The child's age, gender, vital signs (blood pressure, radial pulse, respiratory rate and body temperature) and factors indicating sleep quality ( night sleep duration/hour and night awakenings/number). In the study, a lightened and musical baby mobile, which facilitates the falling asleep of children and allows them to continue their sleep, was used in the rooms of the children in the hospital. In the study, In the study, a lightened and musical baby that can be hung on the wall and fixed on a flat surface was used. An illuminated musical mobile with light emitting diode (LED) lights and a reflective interior surface, providing night sky projection on the ceiling and walls, with 5 different color options, 4 function keys and soft music, was used.

Intervention:

Children in the intervention and control groups, who were admitted to the pediatric emergency clinic, were monitored by being connected to the pulse oximeter device located at the bedside. Vital signs were measured and recorded first thing in the morning (at 08:00) on the intervention day. The child's age, gender, and factors defining sleep quality before the intervention (1st evaluation) were asked face-to-face to the mothers and their answers were recorded in the CSQEF. At 19:00, a mobile with light and music was placed in the middle of the bedside table in the room of the children in the intervention group. Checked the volume, lighting color, pattern and rotation function. Sound; set to medium level, which facilitates the transition to sleep. lighting color; set to a yellow color that provides dim light and is not distracting. As a pattern; Reminiscent of the night, the moon-star projection and rotation function were used.The patient room of the children in the intervention and control groups was illuminated and the window blinds were closed to provide a dark environment. Vital signs of the children in the intervention and control groups were measured and recorded at 20:00. The mobile with light and music placed in the room of the children in the intervention group was started at 20:00. The children in the control group did not use lightened and musical baby mobile, and the routine sleep pattern was maintained. Children in the intervention and control groups at 02:00 (during sleep) and 08:00; Vital signs were measured and recorded. The next morning on the intervention day (at 08:00); The mothers in the intervention and control groups were asked face-to-face about the factors that define the sleep quality of the children in the intervention and control groups between at 20:00 and 08:00 (2nd evaluation) and that their impair (1st evaluation) and their answers were recorded in the CSQEF.

Being tested
lightened and musical baby mobile
Keywords
Pediatric emergency clinic, Sleep, Sleep quality, Lightened and musical baby mobile
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lightened and musical baby mobileDevice

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

Study groups in NCT05129839
Study groupRoleWhat they receive
Lightened and Musical Baby Mobile GroupExperimentalThe children in the study group were applied a lightened and musical baby mobile before sleeping at night.
Receives: Device: lightened and musical baby mobile
Control GroupNo interventionThe children in the control group were not given lightened and musical baby mobile, and their routine sleep patterns were continued.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identifying children's sleep quality

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start1 Sep 2019
  3. Primary completion20 Sep 2019
  4. Study completion25 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05129839
Sponsor's protocol ID
2019/05-15
Status last verified
Nov 2021
First submitted
24 Oct 2021
Last updated
3 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing lightened and musical baby mobile in people with Sleep and Nursing Caries, run by Maltepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identifying children's sleep quality (time frame: Change in the night sleep duration and night awakenings of children in two days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.

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