Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05180058 |
| Other study ID # |
oral nasogastric tube |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2022 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Karamanoglu Mehmetbey University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aimed to reduce the pain and increase comfort during the orogastric tube insertion
(OGT) procedure, which is routinely applied to feed these babies at 32-34 weeks of age, in
preterm newborns with a sucking reflex.In addition, this study also aimed to develop an
atraumatic OGT attachment protocol by combining wrapping, fetal position, breast milk and
oral sucrose combined therapy.
It was planned as a randomized double-blind and controlled experimental study to evaluate the
efficacy of using In addition, this study also planned to develop the atraumatic OGT
insertion procedure through combined therapy of wrapping, fetal position, breast milk, and
oral sucrose. The population of the research consists of preterm babies who are treated in
the Neonatal Intensive Care Unit of Selcuk University Hospital. Babies to be sampled are
preterm babies who are between 32 and 34 weeks of gestation.
Preterm newborns will be randomly divided into five groups;
- Group 1: Control
- Group 2: Wrapping + breast milk (2 ml)
- Group 3: Wrapping + oral sucrose (0.2 ml/kg 20% sucrose)
- Group 4: Fetal position + breast milk (2 ml)
- Group 5: Fetal position + oral sucrose (0.2 ml/kg 20% sucrose) In the NICU, OGT
insertion will be performed by the clinical nurse as part of the treatment for preterm
newborns, which the clinic physician deems necessary. The clinical nurse and clinician
will be responsible for OGT insertion in preterm newborns. In this study, only wrapping,
fetal positioning, oral breast milk and sucrose delivery methods will be applied to
preterm newborns by the researcher. In this context, the responsibility of the
researcher in the study will be to apply non-pharmacological methods to preterm newborns
only before OGT insertion and to evaluate the pain symptoms in preterm newborns during
and after OGT insertion.
The obtained data will be evaluated in SPSS-21 package program in computer environment.
Normality tests, chi-square, t test, Anova, and advanced analysis will be used when necessary
in the analysis of the data. The relationship between the mean score of the scale and other
variables will be evaluated by correlation regression analysis. Significance will be accepted
as p<0.05.
Description:
Ethical and institutional permissions were obtained before starting to collect the data.
Written consent will be obtained from all parents via a voluntary consent form. Preterm
newborns will be randomly selected into 5 groups.
- Group 1 (Control Group); Wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose
and fetal position+breastmilk methods were not applied to preterms in the routine care
group. However, in order to be an ethical practice and to provide ethical standard care
intervention, verbal relaxation and soft touch applications were applied by the
researcher in the procedure.
- Group 2 (Wrapping + Breastmilk Group); Preterm newborns will be wrapped by the
researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by
the researcher with a sterile syringe 2 minutes before the OGT insertion to the same
newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the
upper part of the tongue, through an injector. Preterm newborns will be recorded with a
video camera for 10 minutes before the procedure and for 5 minutes during and after the
procedure. Then, using video recordings, the pain and comfort of newborns will be
evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4
measurements) during and after the procedure.
- Group 3 (Wrapping + Oral Sucrose Group); Preterm newborns will be wrapped by the
researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given
to the same newborn by the researcher with a sterile syringe 2 minutes before OGT
insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn
on the upper part of the tongue through an injector. Preterm newborns will be recorded
with a video camera for 10 minutes before the procedure and for 5 minutes during and
after the procedure. Then, using video recordings, the pain and comfort of newborns will
be evaluated at 1 minute before the procedure, during and after the procedure at 1
minute and 2 minutes (4 measurements).
- Group 4 (Fetal Position + Breastmilk Group); The fetal position will be given to the
preterm newborn immediately after 2 ml of breast milk is given by the researcher 3
minutes before OGT insertion. Breast milk will be given slowly into the mouth of the
preterm newborn, on the upper part of the tongue, through an injector. The preterm
newborn will remain in the fetal position for 5 minutes during and after the procedure.
Newborns will be recorded with a video camera before, during and after the procedure.
Then, using video recordings, the pain and comfort of newborns will be evaluated at the
1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements)
during and after the procedure.
- Group 5 (Fetal Position + Oral Sucrose Group); The fetal position will be given to the
preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3
minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the
preterm newborn on the upper part of the tongue by means of an injector. At the end of
the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The
preterm newborn will remain in the fetal position for 5 minutes during and after the
procedure.
Newborns will be recorded with a video camera before, during and after the procedure. Then,
using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute
before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the
procedure.
Hypotheses (H1) There is a significant difference between the methods applied in the OGT
insertion procedure (wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal
position+breastmilk) in terms of heart rate in preterms.
There is a significant difference between the methods applied in the (H2) OGT insertion
procedure in terms of oxygen saturation of preterms.
(H3) There is a significant difference between the methods applied in the OGT insertion
procedure in terms of the estimated pain score of preterms.
(H4) There is a significant difference between the methods applied in the OGT insertion
procedure in terms of the estimated distress score of preterms.
(H5) There is a significant difference between the methods applied in the OGT insertion
procedure in terms of the comfort level of preterms.
(H6) There is a significant difference between the methods applied in the OGT insertion
procedure in terms of the mean of preterm pain in preterms.
