Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05606458 |
| Other study ID # |
UludagUniversity/AKKAYAGUL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 25, 2019 |
| Est. completion date |
January 25, 2020 |
Study information
| Verified date |
November 2022 |
| Source |
Uludag University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Newborn screening programs are preventive health services that have a significant place in
public health programs in developed and developing countries worldwide. For these scans, heel
blood is taken from the newborn, and the heel blood collection procedure applied for
diagnostic purposes is one of the most common painful procedures applied to the newborn.
Pharmacological and non-pharmacological pain management may be necessary to reduce and
minimize pain during painful procedures in the neonatal intensive care unit. One of the
non-pharmacological applications applied during acute procedural pain in the newborn is
sensorial saturation, which consists of multisensory stimulation (sensitive touch, massage,
auditory, visual, sense of taste, and smell). This study aimed to examine the effect of
multisensory stimulation applied by the mother during the heel blood collection procedure in
newborns on reducing pain and to evaluate the effects of family-centered practice on the
state anxiety of mothers. This study was carried out as a randomized controlled, experimental
study. Ethical approval was obtained before starting the study. In addition, written informed
consent was obtained from the families of the newborns in the control and intervention
groups. The study population consisted of newborns born in a hospital in Turkey between July
2019 and January 2020, and whose heel blood was taken for routine metabolic screening by the
Ministry of Health. The sample group consisted of 80 randomly assigned newborns, 40 in the
intervention group and 40 in the control group. Newborn mothers in the intervention group
gave their babies multisensory stimulation(speech, touch, breastfeeding, eye contact,
maternal skin odor) before, during, and after the procedure. The newborns in the control
group underwent routine heel blood sampling in the baby room under a radiant heater. The
Neonatal Infant Pain Scale (NIPS) was used for pain assessment. The NIPS score was evaluated
by the researcher before the procedure, during the procedure, and 1 minute after the
procedure. The State Anxiety Inventory was used to measure the mother's anxiety. The state of
anxiety of the mothers in each group was evaluated before and after the procedure.
Description:
Sensory stimuli can be easily realized with the active cooperation of the mother and, based
on family-centered care, can help parents feel that they are playing an active role in their
baby's care by being involved in their baby's care and can have positive effects on reducing
the pain and stress of the baby during the heel blood collection process.As far as we know,
there is no study in the literature investigating the effectiveness of multisensory
stimulation applied by the mother during the heel blood collection procedure in reducing both
the baby's pain and the mother's anxiety. It is thought that our study will provide new
evidence to nursing care, that more than one sensory stimulus will be provided by the mother,
will increase the baby's sense of confidence and reduce pain, contribute to the importance of
family-centered care, and will be useful to support the results of the current study. This
study aimed to examine the effect of multisensory stimulation applied by the mother during
the heel blood collection procedure in newborns on reducing pain and to evaluate the effects
of family-centered practice on the state anxiety of mothers.Before starting work, S.B.U.
Ethical approval was obtained from the Süreyyapaşa Chest Diseases and Thoracic Surgery
Clinical Research Ethics Committee. To start the research after the ethics committee's
approval, T.C. Permissions were obtained from the Istanbul Provincial Health Directorate and
the Istanbul Tuzla State Hospital management. In addition, written informed consent was
obtained from the families of the newborns in the control and intervention groups. The
research population consisted of all newborns born in Tuzla State Hospital in Turkey/Istanbul
between July 2019 and January 2020 and whose infants were taken for routine metabolic
screening by the Ministry of Health. The sample group consisted of 80 randomly assigned
newborns, 40 in the intervention group and 40 in the control group. Randomization was
provided according to the order of the procedure. The first newborn control group and the
second newborn intervention group were formed. The newborns whose heel blood will be taken
every day of the week during working hours continued from where they left off according to
the order of the procedure. Before the procedure, the necessary materials were prepared, and
the heel blood sheet information was filled in. The mothers of the babies whose heel blood
was taken were informed about the heel blood screening and the research. The form containing
the identification information of the baby and the mother was filled out. Before the
procedure, the mother was asked to fill out the State Anxiety Scale (in both groups, the baby
was with the mother). The newborns in the control group were taken to an open bed under a
radiant heater, leaving the mother's side for routine heel blood collection applied in the
hospital. First of all, the foot of the baby, who was taken to an open bed under a radiant
heater, was warmed in the hands of the nurse for one minute, the area where the baby's heel
blood would be taken was determined, the baby's heel was wiped with 70% alcohol with the help
of a sponge and waited for it to dry, then heel lance was performed. The procedure was
completed after the relevant sections on the pre-prepared heel blood sheet were filled with
blood. A light touch was provided if necessary for the routine comfort of the baby for
ethical reasons. The mothers of the babies whose heel blood was taken in the intervention
group were informed about the steps of the procedure and the multisensory stimulation they
would give to their babies (mother's voice, touching, breastfeeding, eye contact, mother's
skin smell). The baby was started to be breastfed before the procedure and continued until
the end of the evaluation period (1st stimulus). The mother supported her baby's back and
bottom with one hand. He started to touch by positioning the thumb of the other hand to
prevent the baby's nose from being blocked and the other fingers of the same hand to touch
the baby's face (2nd stimulus). The mother started to talk with her baby in a gentle but firm
tone, sometimes using sentences (words, lullabies, songs, etc.) that she wanted to increase
the volume of her baby (3rd stimulus). Talking was started before the procedure and continued
until the end of the evaluation period. The mother was in the baby's sight (4th stimulus).
Clothes were removed as much as possible for the smell of the mother's skin (5th stimulus).
After the baby's foot in the mother's lap was warmed in the nurse's hand for one minute, the
area where the baby's heel blood would be taken was determined. After the baby's heel was
wiped with 70% alcohol and a sponge and waited for it to dry, heel lance was performed. The
procedure was completed after the relevant sections on the pre-prepared heel blood sheet were
filled with blood. If the baby stopped sucking at any time during the procedure, the baby was
placed back on the breast and the procedure continued from where it had left off. In the
study, the data of the baby and the mother was prepared by the researcher mother's age,
mother's occupation, gestational week of the baby, birth weight, gender, mode of delivery,
etc.), the "Neonatal Infant Pain Scale (NIPS)" scale, which will be used in the assessment of
the baby's pain, and the questionnaire form of the State Anxiety Scale to measure the
mother's anxiety was used. NIPS score was evaluated by the researcher before the procedure,
during the procedure, and 1 minute after the procedure. The State Anxiety Scale was
administered to the mother before and after the procedure. The researcher calculated state
anxiety scale scores.
