Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04837326 |
| Other study ID # |
24237859-714 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2016 |
| Est. completion date |
December 30, 2017 |
Study information
| Verified date |
April 2021 |
| Source |
T.C. ORDU ÜNIVERSITESI |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study was conducted to evaluate the effect of using white noise, embracing and
facilitated tucking on physiological parameters, crying duration and pain during heel lance
blood sampling in healthy newborns.
This study was a prospective, randomized controlled trial. The study was conducted with
healthy newborns who were born between 38 and 42 weeks of gestation. The newborns were
divided into 4 groups by the applied pain relief methods during heel lance blood sampling in
newborns; embracing(n=40), white noise(n=40), facilitated tucking(n=40) and control group
(n=40). The physiological changes were evaluated before and after the procedure. NIPS
(Neonatal Infant Pain Scale) was used for pain scoring.
Description:
This study aimed to investigate the effect of white noise, embracing and facilitated tucking
on pain during heel lance blood sampling in newborns.
METHODS This randomized-controlled experimental study was performed to evaluate the effect of
white noise, embracing and facilitated tucking on pain during heel lance blood sampling in
newborns.
Setting and sample:
The study sample consisted of healthy newborns who were born and monitored in the Neonatology
Unit of a university hospital. The sample inclusion criteria were gestational age between 38
and 42 weeks, birth weight of 2500 - 4000 g, Apgar score of 8 and higher at 1st and 5th
minute, having breastfed at least half an hour before the procedure, not showing any disease
symptom, not having congenital anomaly, getting a good hearing test result and not having
received any invasive intervention other than Vitamin K and Hepatitis B vaccine.
Sample size:
Following previous studies, G*Power (v3.1.9.2) was deployed to determine the sample number.
According to Jacob Cohen's effect size coefficients, assuming that evaluations carried out
among four independent groups would have a large effect size (d=0.40), it was determined that
the groups should comprise least 40 people, with a total of 160, for levels of α=0.05 and
1-β=0.95 (80% power). Children were assigned to 4 subgroups through randomization performed
using a computer program (www.randomizer.org): group 1 was the control group children who
received no intervention for pain relief (n = 40); group 2 received facilitated tucking (n =
40); group 3 received embracing (n = 40); and group 4 received white noise (n = 40).
Intervention:
The mothers were informed by the researcher about the purpose of the study before collecting
data. The infants were held by their mothers so that their faces, arms, legs and respirations
could be easily viewed by the camera to evaluate the NIPS. All heel lance procedures were
performed by the same nurse working on the day shift (who had 6-year NICU experience). The
heel lance blood sampling point (outer side of the left heel), the lancet used in the
procedure, the sampling technique, and the antiseptic solution (70% alcohol) used in for the
procedure were the same for all the groups. The heel lance blood sampling procedure was
performed by the researcher in the blood sampling room in the Neonatology ward. Suitable
environmental conditions (ambient temperature, silent environment, etc.) were ensured in the
study room for the infant's comfort. A saturation probe was inserted to the right wrist of
the infant to monitor him/her. The behavioral responses to pain and crying durations of all
the responses were recorded by camera before, during and after the procedure. Then, these
records were played and the NIPS scores and crying durations of the infants were evaluated.
The physiological changes were recorded before, during and after the procedure, respectively.
In the data collection stage, 3 persons (nurse putting the infant in facilitated tucking
position, nurse taking blood sample, researcher shooting video) were required for facilitated
tucking position; 2 persons (nurse taking blood sample and researcher shooting video) for
maternal embracing since the infant was held by the mother and 2 persons (nurse taking blood
sample and researcher shooting video) for white noise.
Heel Lance Blood Sampling in Facilitated Tucking Position:
The infants were put in facilitated tucking position by an experienced newborn nurse. They
were put in facilitated tucking position so that their arms and legs were in a flexed midline
position close to their trunk in a side-lying position. They were positioned so that they
could move their extremities freely. They were held in facilitated tucking position for 120
seconds before the procedure. They were kept in facilitated tucking position until the blood
sample was taken from the right heel using a lancet. They were released 60 seconds after the
procedure and monitored for 120 seconds. The blood samples were taken by the researcher after
inserting the lancet in the first try.
Heel Lance Blood Sampling When the Infant is Embraced by the Mother:
The mother, whose privacy was protected, embraced the infant for 120 seconds before the
procedure. The infant was embraced by the mother during the heel lance blood sampling from
the left heel using a lancet. They were released 60 seconds after the procedure and monitored
for 120 seconds. The blood samples were taken by the researcher after inserting the lancet in
the first try.
Heel Lance Blood Sampling Using White Noise:
The 'Don't Let Your Baby Cry, PT.2' track from the 'Colic' album by Orhan Osman using the
'The Happiest Baby' album by Dr. Harvery Karp which was composed only of intrauterine was
made listened to the infants via Xperia Ultra Mp3 Player for 120 seconds before and 120
seconds after the heel lance blood sampling procedure. While white noise was made listened to
the infants before, during and after the procedure, Digital Sound LeverMeter brand noise
measurement device was put at a distance of 50 cm from the infant and the ambient noise level
was adjusted as 55 dB. The blood samples were taken by the researcher after inserting the
lancet in the first try.
Control Group:
Suitable environmental conditions (ambient temperature, silent environment, etc.) were
ensured in the study room for the infant's comfort. A saturation probe was inserted to the
right wrist of the infant to monitor him/her. A video record was taken for 120 seconds
without any intervention to the infants before and after the heel lance blood sampling
procedure. The blood samples were taken by the researcher after inserting the lancet in the
first try. Heel lance was performed in clinical routine for preterm infants in the control
group.
