Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05135429 |
| Other study ID # |
Newborn |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
September 4, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Karamanoglu Mehmetbey University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study was conducted as a randomized controlled experimental study to determine the
effect of bathing given to premature babies on pain, sleep and vital signs. The data of the
study were obtained from premature newborns born at 34 weeks and above, who were hospitalized
in Selcuk University Hospital Neonatal Intensive Care Unit between 1 June and 31 August 2020.
The sample size was determined as 64 premature newborns. "Interview and Observation Form,
Neonatal Pain/Agitation, Sedation Scale" was used for data collection. The data were
evaluated with the SPSS 21.0 package program using percentage, mean, standard deviation,
chi-square, t test, Anova and Tukey advanced analysis test.
The research was carried out in the following order. All permissions were obtained for data
collection. Individual characteristics were obtained from family members and recorded in the
questionnaire. Before the procedure, the pain levels of the newborns were evaluated and
recorded. The status of babies in the study or control group was randomly determined
according to the hospitalization day (www.randomizer.com).
The newborns in the study group were given a baby bath. The baby's body temperature, pulse,
respiration, systolic and diastolic blood pressure, saturation, oxygen demand, and N-PASS
scores were evaluated and recorded by two observers before the bath, at the 15th, 30th and
60th minutes after the bath.
No intervention was given to the newborns in the control group. However, body temperature,
pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand and
N-PASS scores were evaluated and recorded in accordance with the measurement intervals of the
newborns in the study group.
Cohen's kappa analysis was performed to assess interobserver agreement. Since the
inter-observer agreement was found to be excellent (k=0.85), analysis was performed with an
observer evaluation.
All newborns were measured at the same time of the day.
Description:
The research will be carried out in the second and third level Neonatal Intensive Care Unit
of X University Medical Faculty Hospital. 52 nurses and three neonatologists work in the
unit. 12 nurses (in-clinical training nurse, nutrition nurse) work during the day and 10
nurses at night. The average number of babies per nurse for care is three. Second and third
level patients are hospitalized in the clinic. The total number of beds is 45, with 36 beds
at the third level and nine beds at the second level. The average number of babies admitted
to the unit and treated is 55/550 monthly/yearly. (Due to the Covid 19 epidemic, the number
of hospitalized patients is less than in previous years.)
Outside the unit, there are mother-baby adjustment rooms where the resting needs of mothers
are met. There is no restriction on visiting hours for mothers in the clinic, mothers can see
and take care of their babies whenever participants want 24/7. Before the Covid 19 epidemic,
fathers had visiting hours, but during the epidemic, father visits were abolished.
The sample size was calculated with the G*Power 3.1.5 program with 95% power and 10%
difference at 0.05 significance level. The sample size was determined as 64 newborns, 32
children for each group. At the end of the study, Post Hoc power analysis will be performed
in order to determine the adequacy of the number of newborns included in the study. When it
is determined that 95% power is reached, the data collection process will be terminated.
Randomization of control and study groups; The status of the children to be included in the
study in the control or study group will be determined by using "stratification and
randomization methods with blocks", taking into account the hospital registration numbers and
gender of the newborns. Accordingly, children will be stratified as "girls and boys" for the
gender variable. 32 premature newborns will be included in each of the research groups. Since
the newborns and their families do not meet each other during the data collection process,
the interaction of the newborns in the study and control groups with each other will be
prevented.
