Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06455631 |
| Other study ID # |
E-10840098-202.3.02-3029 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 10, 2024 |
| Est. completion date |
April 29, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Fenerbahce University |
| Contact |
Negarin Akbari, Ph.D |
| Phone |
00905352679510 |
| Email |
negarin.akbari[@]fbu.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The research will be conducted using a randomized controlled experimental method.The preterm
newborns included in the study will be randomized into three groups using the sealed envelope
method. In the facilitated tucking position + oral breast milk group, preterm newborns will
be placed in the facilitated tucking position 15 minutes before tape removal and given oral
breast milk 2 minutes before. This position will be maintained until 2 minutes after tape
removal. Preterm newborns in the kangaroo care + oral breast milk group will undergo kangaroo
care 15 minutes before tape removal and receive oral breast milk 2 minutes before. Kangaroo
care allows mother-baby interaction but no feeding. In the control group, newborns will
undergo routine nesting with gentle touch and verbal comfort provided if they cry.This study
is designed to evaluate the effect of the fetal position, oral breast milk administration,
and kangaroo care on pain during tape removal in preterm newborns.
Description:
In the study, the groups of the babies will be determined by a lottery method. Preterm babies
included in the study will be randomly assigned to three groups using a closed envelope
method. To ensure equal distribution of babies according to gestational age, two sets of
envelopes will be created for 30-33+6 weeks and 34-36+6 weeks. An independent nurse working
in the NICU will be asked to select a paper from the closed envelope corresponding to the
baby's gestational week. Based on the number written on the selected paper, the baby will be
included in the study group. The groups will be: Group 1 - facilitated tucking position +
oral breast milk, Group 2 - kangaroo care + oral breast milk, and Group 3 - control group.
After the babies are assigned to the groups, data collection will begin.
Before data collection, the researcher will provide necessary information about the study to
the families of the newborns who meet the sample selection criteria and will answer their
questions. After obtaining written consent from the parents of the babies who agree to
participate, they will be included in the study. The information in the introductory
information form for the newborn and parents will be recorded by the researcher.
1. Breast Milk Administration Procedure During tape removal, babies will be given breast
milk orally. The amount of milk given to the baby will be adjusted according to
gestational age (1.5 ml for 30+1-32 weeks; 2 ml for 32+1-36+6 weeks) (Peng et al.,
2018).
2. Tape Removal Procedure The same product (medical tape suitable for the baby and causing
minimal tissue trauma) will be used to effectively secure medical devices. To remove the
tape, moistened gauze or saline pads will be used to gently and slowly remove it
parallel to the skin surface horizontally.
1. GROUP: Interventions for the Facilitated Tucking Position + Oral Breast Milk Group Preterm
newborns in the facilitated tucking position + oral breast milk group will be placed in the
facilitated tucking position by the researcher 15 minutes before the tape removal procedure
and given oral breast milk 2 minutes before the tape removal procedure. The facilitated
tucking position will be maintained until 2 minutes after the tape removal procedure. To
prevent heat loss, preterm newborns will be positioned in the right lateral position inside
the incubator by using the incubator windows without opening the incubator lid, with their
arms and legs brought to the midline in the facilitated tucking position.
2. GROUP: Interventions for the Kangaroo Care + Oral Breast Milk Group Preterm newborns in
the kangaroo care + oral breast milk group will receive kangaroo care from the researcher 15
minutes before the tape removal procedure to alleviate pain; oral breast milk will be given 2
minutes before the tape removal procedure. The mothers of the babies in this group will be
seated in the neonatal intensive care unit (NICU), and a nurse will place the newborn upright
between the mother's bare breasts, slightly extending the head to facilitate breathing. The
legs will be spread under the mother's chest and positioned in flexion. The back will be
wrapped with extra fabric up to the ear level to prevent heat loss. During the contact, the
mother will be allowed to talk to, move, or engage in other activities with her baby, but
feeding will not be permitted. After ensuring the comfort of both the newborn and the mother,
this position will be maintained for 15 minutes before the tape removal procedure.
Subsequently, the nurse will perform the tape removal while the newborn is in the kangaroo
care position, and the mother and baby will remain in kangaroo care for an additional 2
minutes. Once data collection is complete, kangaroo care can continue based on the mother's
wishes, the baby's condition, and clinical circumstances.
Interventions for the CONTROL Group Newborns in the control group will undergo the routine
nesting procedure of the clinic. All newborns will be placed in the lateral position. For
ethical reasons, if babies cry during or after the procedure, gentle touch and verbal comfort
will be provided to them.
In all experimental groups, heart rate, respiratory rate, oxygen saturation values, and
PIPP-R scores will be measured and recorded at the following time points:
- 0 minutes: Measurements will be taken and recorded immediately before any intervention
while the baby is in a resting position. Then, depending on the baby's group, either the
facilitated tucking position or kangaroo care will be applied.
- 13 minutes: Measurements will be taken and recorded immediately before giving oral
breast milk.
- 15 minutes: Measurements will be taken and recorded during the tape removal procedure.
- 17 minutes: Measurements will be taken and recorded 2 minutes after the tape removal
procedure, while non-pharmacological interventions continue.
- In the control group, similar measurements and assessments will be conducted at the same
time intervals and recorded.
The PIPP-R scores of all groups will be recorded on a data assessment form by two independent
evaluators based on video recordings.
