Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05431452 |
| Other study ID # |
206337 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Suleyman Demirel University |
| Contact |
Serife Tutar |
| Phone |
+905053126429 |
| Email |
serifeguven[@]sdu.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pharmacological and non-pharmacological methods are used to control interventional pain in
preterm newborns. Non-pharmacological methods should be preferred in the management of pain,
especially during painful minor invasive procedures (blood collection, orogastric tube
insertion, aspiration, etc.) applied during the day. Some of these methods are; kangaroo
care, breast milk, fetal positioning, breastfeeding, listening to music and massage.
Taking heel blood from babies who are being treated in the neonatal intensive care unit is
among the duties, authorities and responsibilities of neonatal intensive care nurses. In
addition, the effective management of pain by using non-pharmacological methods is among the
professional ethical responsibilities of nurses working in neonatal intensive care units.
While fulfilling these responsibilities, nurses should conduct researches with high levels of
evidence and benefit from the researches effectively. In this context, determining the most
effective non-pharmacological method and activating it in a clinical setting form the basis
of nursing practices. In this context, the aim of our research is; The aim of this study is
to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast
milk and breast milk, and kangaroo care in reducing pain during heel blood collection in
preterm newborns.
Description:
The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined
fetal position with breast milk and breast milk, and kangaroo care in reducing pain during
heel blood collection in preterm newborns. The sample of the study will consist of late
preterm newborns who meet the inclusion criteria of the study. It is envisaged that 40 babies
will be included in the sample for each group. Randomization will be done in order to provide
an equal number of samples for the intervention and control groups in the study. In the
randomization to be made, the "simple randomization method" will be used in order to provide
equal samples for all three groups. The data of the study will be collected by the clinical
nurse working as a nurse in the clinic where the research is conducted, in accordance with
the randomization scheme. Physiological parameters of all babies will be monitored on the
monitor during the interventions. During the research, all groups will be video-recorded for
10 minutes before the procedure, during the procedure and for 5 minutes after the procedure.
After the data of the study are collected, all video recordings will be examined by two
researchers (a neonatal intensive care nurse and a neonatal intensive care specialist) and
PIPP-R The scale will be filled in by these two independent observers. Descriptive statistics
(mean, standard deviation) will be used for the quantitative variables of the research
determined by measurement, and descriptive statistics (number, percentage) will be used for
the qualitative variables determined by counting. The conformity of the data to be used with
the normal distribution will be determined by the Shapiro-Wilk test. In paired comparisons
between variables with two categories such as gender, t-test, Analysis of Variance will be
applied to find the differences between variables with three or more categories such as
group. Paired-sample t-test will be applied between dependent groups for the features that
are significant as a result of the analysis of variance. Mann Whitney U test, Wilcoxon test
and correlation analyzes will be used to evaluate the relationships between dependent and
independent variables. Results will be evaluated at 95% confidence interval and p<0.05
significance level.
