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

Pain, Acute Clinical Trial

— (pain)  

Official title:

The Effect of Facilitated Tucking, Maternal Breast Milk Odor and Non Nutritive Sucking During Heel Stick on Procedural Pain in Premature Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281367
• Other study ID #: 1400829255739
• Status: Completed
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: January 2, 2022

Study information

• Verified date: March 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2, 2022
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Neonatal Intensive Care Unit
• Pain, Acute

Intervention

Procedure:
• Breast milk odor group
The researcher applied the breast milk that dripped on the pad for 3 minutes before the heel stick for 36 premature newborns in the breast milk odor group. About three cc breast milk dripped onto a sterile pad and placed at a distance of 10 cm from the nose of the newborn. It continued until 3 minutes after the invasive procedure. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
• Facilitated tucking group
The Facilitated tucking position was given to 36 premature newborns in the Facilitated tucking group, from 3 minutes before to 3 minutes after the heel stick procedure. Premature newborns were kept in the facilitated tucking position by the investigator using the incubator windows without opening the incubator cover to prevent heat loss of the newborn. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
• Non-nutritive sucking group
36 premature newborns who were in the non-nutritive sucking group were given a silicone pacifier suitable for the week of the baby's mouth from 3 minutes before to 3 minutes after the heel stick. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
• 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. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Golestan University of Medical Sciences	Gorgan	Golestan

Sponsors (1)

Lead Sponsor	Collaborator
Negarin Akbari

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Crying time	The researcher recorded the crying time in second (sec) during heel stick.	During procedure (During heel stick the total crying time was measured from where it starts until the over.)
Primary	Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)	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.	Pain was measured at 1 minutes before the procedure by two researchers independently.
Primary	Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)	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.	Pain was measured at 2 minutes before the procedure by two researchers independently.
Primary	Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)	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.	Pain was measured at 3 minutes before the procedure by two researchers independently.
Primary	Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)	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.	Pain was measured during the procedure by two researchers independently.
Primary	Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)	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.	Pain was measured at 1 minutes after the procedure by two researchers independently.
Primary	Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)	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.	Pain was measured at 2 minutes after the procedure by two researchers independently.
Primary	Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)	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.	Pain was measured at 3 minutes after the procedure by two researchers independently.
Secondary	Heart rate during 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).	from 4 minutes before heel stick to 4 minute after heel stick
Secondary	Respiratory rate	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).	From 4 minutes before heel stick to 4 minute after heel stick
Secondary	Oxygen saturation	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).	From 4 minutes before heel stick to 4 minute after heel stick