Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05440669 |
| Other study ID # |
B.30.2.ATA.0.01.00/448 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 19, 2022 |
| Est. completion date |
January 19, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to determine the effect of white noise application on the pain and
stress level of newborns receiving oxygen support via nasal CPAP in the Neonatal Intensive
Care Unit. The research is a randomized controlled trial. The population of the study will be
infants aged 0-28 days who were hospitalized for treatment in Şanlıurfa Training and Research
Hospital between July and December 2022. The research sample; Babies of families who are
hospitalized in the Neonatal Intensive Care Unit on the specified dates and meet the research
criteria and volunteer to participate in the research will be formed. "Survey Form",
"Follow-up Form" and "ALPS Neo Neonatal Pain and Stress Assessment Scale", White Noise, MP 3
Player, and Sound Decibel Measuring Device will be used to collect data.
Description:
Type of Study: The study is planned experimentally with a randomized control group.
Place and Time of the Research: The research will be carried out between June-December 2022
in Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit. There are 130
incubators in total, with 53 beds at the 2nd level and 54 beds at the 3rd level. 55
respirators, 4 fully equipped transport incubators with respirators, isolation room, 4
hypothermia devices, 2 Aeeg devices etc. are available. Treatments that can be performed in
the Neonatal Intensive Care Unit; respiratory support (ventilator therapy), thoracic tube
insertion, blood exchange, total parenteral nutrition, phototherapy, percutaneous catheter
applications, patient transport with 24-hour incubators with breathing apparatus, dialysis
catheter insertion and follow-up, colostomy care, etc. are treatments. A total of 133 nurses
work.
Population and Sampling of the Study: The population of the study will consist of infants
aged 0-28 days who will receive oxygen therapy in nasal CPAP by being hospitalized in the
Newborn Intensive Care Unit of Şanlıurfa Training and Research Hospital between July and
December 2022 due to respiratory distress.
In this study, "prior power analysis" was used to determine sample adequacy. In the power
analysis used, "Cohen's standard effect size reference technique" was chosen. In this case,
for the t-test in independent groups, it was determined that if the study was advanced with
80 participants in two groups with 40 participants in each group, 80% power could be reached
at a significance level of 0.05, at a 95% confidence interval. Against the possibility of
data loss, it was decided to collect data from a total of 100 individuals by adding 10% more
backup sample to this number. In order to ensure randomization, babies who meet the criteria
will be taken to the control group, who are in the first week, and to the experimental group,
respectively, and this cycle will be continued until the end of the research, and
randomization will be ensured.
Inclusion Criteria for Research
- 38-40 weeks of gestation
- Receiving oxygen support in nasal CPAP
- Not taking opioids or sedatives 4 hours before the procedure.
Data Collection Tools to be Used in the Study: : "Survey Form, Neonatal Pain and Stress
Assessment Scale, Follow-up Form, White Noise, MP 3 Player, and Sound Decibel Measuring
Device" will be used to collect research data.
Questionnaire Form: In this form, which was prepared by the researcher by examining the
literature; There will be questions about the introductory features of the newborn.
ALPS Neo Neonatal Pain and Stress Rating Scale: The "ALPS Neo Neonatal Pain and Stress Rating
Scale" was developed in 2014, based on the individualized developmental care of the newborn,
in order to evaluate pain and stress in premature and term newborns. In 2017, this scale was
adapted to Turkish and its validity and reliability study was conducted. The scale is a
3-point Likert-type scale consisting of 5 parameters: "newborn's facial expression, breathing
pattern, tone of the extremities, hand/foot activities, and activity level". As the scores
increase, pain and stress increase in the newborn. As a result of the evaluation, "3-5 points
indicate the presence of mild pain and stress, and more than 5 points indicate the presence
of severe pain and stress".
Follow-up Form: It is a form used to record the newborn's cardiorespiratory parameters (peak
heart rate, oxygen saturation), ALPS Neo pain scale, and crying time evaluated during nasal
CPAPP.
Intervention Tool to be Used in Research White noise: Dr. Orhan Osman to calm the babies. It
was prepared by making use of the album "Happy Baby" prepared by Harvery KARP, which consists
of only intrauterine sounds.
Sound decibel meter: It will be used to determine the sound level of the white noise concert.
The application will be made so that the level in the environment is 45-55 dB.
Mp3 player: It will be used for listening to white noise. Data Collection The research data
will be collected from the babies of the families who agreed to participate in the research
after the researcher gave the parents of the patients preliminary information about the
research (the purpose of the research, why the research was conducted, the attempt to relieve
the neonatal pain with a non-pharmacological method, etc.) and after their written consent
was obtained. The purpose of making the patient listen to white noise; It is to reduce the
pain and stress level of the procedure to a minimum level by ensuring that the patient calms
down.
Experimental Group: Babies in this group will be listened to white noise for five minutes
before nasal CPAP is applied.5. After 1 minute, nasal CPAP application will be started. White
noise will continue to be listened during the application. Before the application, during the
application, after the patient will be evaluated with the ALPS-Neo Neonatal Pain and Stress
Rating Scale and the scale and follow-up form will be filled.
Control Group: Nasal CPAP will be routinely applied to babies in this group and the patient
will be evaluated with the ALPS Neo Neonatal Pain and Stress Rating Scale before, during and
after the procedure, and the scale and follow-up form will be filled.
Evaluation of Data Evaluation of statistics will be done by blinding method. Data will be
collected by the researcher. The analysis of the data will be done by the statistician. The
data will be sent after making sure that the data is coded in a way that preserves the
blinding (without knowing which of the control and experimental groups). SPSS package program
will be used for data analysis. The normality distribution of the data will be determined by
the Kurtosis and Skewness coefficients. For the analysis of the data, "t-test for normally
distributed measurements in the comparison of paired groups with numbers, percentages, mean
and standard deviations, and Mann Whitney U test for non-normally distributed measurements"
will be used. In the comparison of multiple groups, "Analysis of variance" will be used for
normally distributed measurements, and Kruskall Wallis test for non-normally distributed
measurements.
Ethical Principles of Research In order to carry out the research, official permission will
be obtained from the relevant institution with ethical approval. The purpose of the study
will be explained to the parents of the babies with the research group criteria, the
questions asked will be answered and their verbal and written consent will be obtained.
Parents will be informed that the data collected during the research will be processed
anonymously, confidentially, and will not be used outside of the study in question, and that
they can leave the study whenever they wish. Since the research is based on the use of data
obtained from humans, and therefore, due to the necessity of observing personal rights, the
relevant ethical principles "Informed Consent", "Volunteerism" and "Protection of
Confidentiality" will be followed.
