Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05462964 |
| Other study ID # |
UludagUniversity-AKKAYAGUL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 25, 2018 |
| Est. completion date |
February 18, 2020 |
Study information
| Verified date |
July 2022 |
| Source |
Uludag University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Orogastric tube(OGT) placement, which is used for monitoring, diagnostic and therapeutic
purposes, causes pain and stress in premature and term newborns. Non-pharmacological pain
intervention with pacifiers and sweetener solutions (sucrose, dextrose, etc.) in newborns is
a viable nursing approach to reduce pain. In the limited number of studies in the literature,
it was seen that pacifiers and sucrose were used in nasogastric tube(NGT) applications and
they were especially focused on premature babies. In our study, due to the fact that it was
conducted in term newborns and, unlike the limited number of studies, OGT was placed in the
stomach in the form of a pacifier and a 25% dextrose pacifier leaking from the rim. Our study
was conducted as a randomized controlled experimental study to examine the effect of using
pacifiers and dextrose pacifiers on pain reduction during orogastric tube placement, and also
to evaluate the effects on behavioral response and physiological parameters (heart rate,
oxygen saturation) in newborns.In addition, it was thought that the fact that the study was
carried out by passing a pacifier and a pacifier sweetened with 25% dextrose, would
facilitate progress and reduce trauma by stimulating the swallowing reflex in newborns via a
pacifier as in adults.The population of the study consisted of term newborns at 38-42 weeks
of gestation who were hospitalized in the Neonatal Intensive Care Unit of a hospital in
Turkey between April-December 2019. The sample group randomly consisted of 60 newborns
(Control group: 20, Intervention group with only pacifiers:20, with dextrose flavored
pacifiers:20). 20 babies in the intervention group were given only pacifiers and 20 babies
were given a pacifiers flavored with dextrose 2 minutes before the OGT insertion. The
procedure was performed by leaking the tube from the edge of the pacifiers. Routine OGT
insertion was performed in the control group. The data collection process was recorded with a
camera. The Neonatal Infant Pain Scale (NIPS), the highest heart rate and lowest oxygen
saturation from physiological pain responses, and crying time from behavioral parameters were
evaluated by the researcher by watching the camera recording. Variance analysis, Shapiro
Wilk, Kruskal Wallis, Chi-square, Bonferro, and Wilcoxon tests were used in the statistical
analysis of the study. The SPSS v22 package program was used for statistical analysis and the
significance level was taken at α=0.05.
Description:
Painful and invasive procedures for follow-up, diagnostic and therapeutic purposes are an
inevitable part of care in the neonatal intensive care unit. Effective pain management is at
the core of nursing care and is based on a comprehensive assessment of the infant and its
pain. Nurses and the interdisciplinary healthcare team have a responsibility to prevent or
minimize pain during these procedures. Studies to reduce pain during OGT insertion were
generally performed in premature newborns, but there are few studies performed in term
newborns. It has been observed that there are not enough studies on OGT that focus on NGT
placement in the studies. In the studies examined, the use of dextrose and pacifier alone,
which are non-pharmacological methods in reducing pain, were generally discussed, and no
studies involving the combined use were found. It is thought that our study will be useful in
terms of the fact that feeding tube placement, which is known to be a painful and stressful
procedure, will be performed in term newborns, presenting new evidence to nurses for reducing
pain and stress, and supporting the existing study results.
This study is a randomized controlled experimental study to examine the effect of using
pacifiers and dextrose pacifiers on pain reduction during orogastric tube placement in
newborns, as well as to evaluate behavioral responses and physiological changes in newborns.
In addition, it was thought that the fact that the study was carried out by passing a
pacifier and a pacifier sweetened with 25% dextrose, would facilitate progress and reduce
trauma by stimulating the swallowing reflex in newborns via a pacifier as in adults. Ethical
approval was obtained from the Bursa Uludağ University Faculty of Medicine Clinical Research
Ethics Committee before starting the study. In order to start the research after the approval
of the ethics committee, T.C. Permissions were obtained from the Istanbul Provincial Health
Directorate and the Istanbul Tuzla State Hospital management. In addition, written consent
was obtained from the families of the newborns in the control and intervention groups, with
an informed consent form. The research was carried out in Turkey/Istanbul Tuzla State
Hospital neonatal intensive care unit between April-December 2019. The population consisted
of term newborns who were hospitalized in the neonatal intensive care unit of Istanbul Tuzla
State Hospital, whose OGT placement procedure was deemed clinically appropriate, and legal
permission was obtained from their families. Of these newborns, a total of 60 newborns, 20+20
in the intervention group and 20 in the control group, were included in the sample group. The
first intervention group consisted of 20 newborns given a pacifier alone, the second
intervention group consisted of 20 newborns given a pacifier sweetened with 25% dextrose, and
20 newborns in the control group. Randomization was provided by the researcher for babies who
met the inclusion criteria of the study during weekday neonatal intensive care unit working
hours. For this; During working hours, the first newborn to be fitted with OGT was in the
control group, the second newborn was given a pacifier only, and the third newborn was in the
pacifier intervention group sweetened with 25% dextrose. When there was not enough OGT
indication (less than 3) on the same day, the application continued in the same order in the
next clinical shift. It was applied in the same way for each group before the procedure.
Information about the baby and the mother in the baby and mother introduction form, which was
prepared by using the literature, was filled in before the procedure. The newborns were
placed under a radiant warmer in an open bed 5 minutes before the procedure. In newborns who
could not be placed under a radiant heater, the application was performed in an incubator.
After the preparation of the necessary materials before the application, the OGT measurement
to be placed was made and the marking process was carried out. A saturation probe was placed
in the baby to monitor heart rate and oxygen saturation. The newborn was prepared for the
procedure by adjusting the camera monitor focused on the baby's face in the field of view. 2
minutes before OGT insertion, 20 babies in the intervention groups were given pacifiers
alone, and 20 babies were given pacifiers sweetened with 25% dextrose. The procedure was
carried out by leaking the tube from the pacifiers. In the control group, routine OGT
placement was performed without giving anything. The data collection process was recorded
with a camera. After the evaluation period was completed and the baby was comfortable, the
recording was stopped. However, the recording continued without any time constraint to
monitor the crying time of the baby who continued to cry during the insertion. The dependent
variables of the study were the score from the NIPS pain scale, oxygen saturation, heart
rate, and crying time.
