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

Not Applicable

Completed

• Conditions: Neonatal Intensive Care Unit; Pain, Acute
• Interventions: Procedure: Breast milk odor group; Procedure: Control group; Procedure: Facilitated tucking group; Procedure: Non-nutritive sucking group

• Registration Number: NCT05281367
• Lead Sponsor: Negarin Akbari

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2021-12-15
• Primary Completion: 2021-12-25
• Study Completion: 2022-01-02
• Study First Submitted: 2022-01-18
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast milk odor group	Breast milk odor group	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.
control grup	Control group	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.
Facilitated tucking group	Facilitated tucking group	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.
Non-nutritive sucking group	Non-nutritive sucking group	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.

Primary Outcome Measures

Name	Time	Method
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)	Pain was measured at 3 minutes after the procedure by two researchers independently.	PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation	From 4 minutes before heel stick to 4 minute after heel stick	Oxygen saturation initially was recorded in each group 4 minutes before starting any intervention. Then, 1,2, and 3 minutes before heel stick, During heel stick, and 1,2,3 minutes after heel stick it again measured (totally eight times).
Heart rate during heel stick	from 4 minutes before heel stick to 4 minute after heel stick	Heart rate initially was recorded in each group 4 minutes before starting any intervention. Then, 1,2, and 3 minutes before heel stick, During heel stick, and 1,2,3 minutes after heel stick it again measured (totally eight times).
Respiratory rate	From 4 minutes before heel stick to 4 minute after heel stick	Respiratory rate initially was recorded in each group 4 minutes before starting any intervention. Then, 1,2, and 3 minutes before heel stick, During heel stick, and 1,2,3 minutes after heel stick it again measured (totally eight times).

Trial Locations

Locations (1)

Golestan University of Medical Sciences; 🇮🇷 Gorgān, Golestan, Iran, Islamic Republic of