Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05129839 |
Other study ID # |
2019/05-15 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2019 |
Est. completion date |
December 25, 2019 |
Study information
Verified date |
November 2021 |
Source |
Maltepe University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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).
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.