Clinical trial NCT05281367: Non-pharmacological Methods in Pain Managment During Heel Stick in Preterm Infants
Official title: The Effect of Facilitated Tucking, Maternal Breast Milk Odor and Non Nutritive Sucking During Heel Stick on Procedural Pain in Premature Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Neonatal Intensive Care Unit
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 144
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
timeFrame: Pain was measured at 1 minutes before the procedure by two researchers independently.
measure: Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
timeFrame: Pain was measured at 2 minutes before the procedure by two researchers independently.
measure: Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
timeFrame: Pain was measured at 3 minutes before the procedure by two researchers independently.
measure: Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
timeFrame: Pain was measured during the procedure by two researchers independently.
measure: Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
timeFrame: Pain was measured at 1 minutes after the procedure by two researchers independently.
measure: Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
timeFrame: Pain was measured at 2 minutes after the procedure by two researchers independently.
measure: Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
timeFrame: Pain was measured at 3 minutes after the procedure by two researchers independently.
Secondary outcomes:
measure: Heart rate during heel stick
timeFrame: from 4 minutes before heel stick to 4 minute after heel stick
measure: Respiratory rate
timeFrame: From 4 minutes before heel stick to 4 minute after heel stick
measure: Oxygen saturation
timeFrame: From 4 minutes before heel stick to 4 minute after heel stick
Other outcomes:
measure: Crying time
timeFrame: During procedure (During heel stick the total crying time was measured from where it starts until the over.)
Locations:
city: Gorgān
country: Iran, Islamic Republic of
facility: Golestan University of Medical Sciences
state: Golestan
Study officials:
affiliation: Istanbul un'vers'ty cerrahpasa-Istanbul,Turkey
name: Negarin Akbari, PhD student
role: PRINCIPAL_INVESTIGATOR
References: