Non-pharmacological Methods in Pain Managment During Heel Stick in Preterm Infants ((pain))

Negarin Akbari

Status: Completed

Conditions: Neonatal Intensive Care Unit; Pain, Acute

Treatments: Procedure: Facilitated tucking group; Procedure: Non-nutritive sucking group; Procedure: Control group; Procedure: Breast milk odor group

Study type: Interventional

Funder types: Other

Identifiers

NCT05281367

1400829255739

Details and patient eligibility

About

Aims and objectives: This study was performed to examine the effects of Non-nutritive sucking, breast milk odor, and Facilitated tucking on preterm infant pain before, during, and after heel-stick procedures.

Design: A randomized clinical trial in a single center.

Methods:

The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital in Iran. Neonates were randomly assigned to four groups: 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Pain score, heart rate, oxygen saturation, and respiratory rate of the babies in all groups before, during, and after the procedure were evaluated by two nurses independently.

Full description

Aim: Due to the necessity of various painful procedures and their side effects on infants, pharmacological and non-pharmacological methods are adopted to reduce the pain. Since pharmacological methods can be associated with several side effects, it is better to use non-pharmacological methods for pain control in newborns. Therefore, the purposes of this study were to compare the effects of three different methods (including Non-nutritive sucking, breast milk odor, and Facilitated tucking) on preterm infant pain before, during, and after heel-stick procedures.

Method: The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital, Iran. Initially, neonates are divided into two groups according to gestational age (including neonates between 31-33 weeks and 34-36 weeks) to moderate the confounding effect of the age, and then the allocation of neonates to four groups was performed.

Using the stratification block randomization method, 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Two researchers viewed the recorded videos independently and evaluate the heart rate, oxygen saturation, respiratory rate, and neonatal pain at 1st,2nd,3rd minute before the procedure, during, and at 1st,2nd,3rd minutes after the procedure according to the Premature Infant Pain Profile (PIPP).

Enrollment: 144 patients

Sex: All

Ages: 1 to 10 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Week of gestation is between 31 and 36 weeks
2. Not being exposed to a painful procedure at least 1 hour before the interventions
3. At least 1 hour has passed since feeding
4. Not taking analgesics and/or sedatives in the last 4 hours
5. Body weight of 1000 grams or more
6. Having mother's milk
7. Not exceeding the 10th day of postnatal age

Exclusion criteria

1. Having ventilator support
2. Having a congenital anomaly
3. Using analgesic / narcotic analgesic drugs
4. Continuous sedative treatment
5. Having a congenital malformation that may cause asphyxia and affect respiration
6. Having intracranial bleeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

144 participants in 4 patient groups

Breast milk odor group

Experimental group

Description:

It is a non-pharmacological method of pain control in which 3 cc of breast milk will be dripped onto a sterile pad and It will be placed at a distance of 10 cm from the nose of the newborn. Precisely, premature newborns' own mothers' milk will be used. For this, mothers of newborns will be contacted and breast milk will be provided for the day of the procedure.

Treatment:

Procedure: Breast milk odor group

Facilitated tucking group

Experimental group

Description:

It is a non-pharmacological method of pain control in which the arms and legs are slowly contracted and placed close to the body. In this method, the baby is placed on its side, the baby's back is gently bent, the legs are folded at an angle of more than 90 degrees, the shoulders are folded up to 90 degrees, and the care hands are placed either on the head near the mouth or Placed on the baby's face.

Treatment:

Procedure: Facilitated tucking group

Non-nutritive sucking group

Experimental group

Description:

It is a non-pharmacological method used to control pain in infants. In this method, babies suck without receiving the nutrient. This can be done by a pacifier, a parent's hand or a nurse.

Treatment:

Procedure: Non-nutritive sucking group

control grup

Experimental group

Description:

The control group will consist of 36 premature newborns who are routinely applied in the clinic. In the clinic where the research was conducted, no attempt is made to reduce pain during heel stick.

Treatment:

Procedure: Control group