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

Primary Purpose

Pain, Acute, Neonatal Intensive Care Unit

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Breast milk odor group
Facilitated tucking group
Non-nutritive sucking group
Control group
Sponsored by
Negarin Akbari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Acute

Eligibility Criteria

1 Day - 10 Days (Child)All SexesAccepts 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

Sites / Locations

  • Golestan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Breast milk odor group

Facilitated tucking group

Non-nutritive sucking group

control grup

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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 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 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 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 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 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 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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
January 18, 2022
Last Updated
March 15, 2022
Sponsor
Negarin Akbari
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1. Study Identification

Unique Protocol Identification Number
NCT05281367
Brief Title
Non-pharmacological Methods in Pain Managment During Heel Stick in Preterm Infants
Acronym
(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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 25, 2021 (Actual)
Study Completion Date
January 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Negarin Akbari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Neonatal Intensive Care Unit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breast milk odor group
Arm Type
Experimental
Arm 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.
Arm Title
Facilitated tucking group
Arm Type
Experimental
Arm 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.
Arm Title
Non-nutritive sucking group
Arm Type
Experimental
Arm 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.
Arm Title
control grup
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Breast milk odor group
Other Intervention Name(s)
Breast milk odor
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Facilitated tucking group
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Non-nutritive sucking group
Other Intervention Name(s)
pacifire
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention 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. 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).
Primary Outcome Measure Information:
Title
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Description
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.
Time Frame
Pain was measured at 1 minutes before the procedure by two researchers independently.
Title
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Description
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.
Time Frame
Pain was measured at 2 minutes before the procedure by two researchers independently.
Title
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Description
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.
Time Frame
Pain was measured at 3 minutes before the procedure by two researchers independently.
Title
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Description
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.
Time Frame
Pain was measured during the procedure by two researchers independently.
Title
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Description
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.
Time Frame
Pain was measured at 1 minutes after the procedure by two researchers independently.
Title
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Description
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.
Time Frame
Pain was measured at 2 minutes after the procedure by two researchers independently.
Title
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Description
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.
Time Frame
Pain was measured at 3 minutes after the procedure by two researchers independently.
Secondary Outcome Measure Information:
Title
Heart rate during heel stick
Description
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).
Time Frame
from 4 minutes before heel stick to 4 minute after heel stick
Title
Respiratory rate
Description
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).
Time Frame
From 4 minutes before heel stick to 4 minute after heel stick
Title
Oxygen saturation
Description
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).
Time Frame
From 4 minutes before heel stick to 4 minute after heel stick
Other Pre-specified Outcome Measures:
Title
Crying time
Description
The researcher recorded the crying time in second (sec) during heel stick.
Time Frame
During procedure (During heel stick the total crying time was measured from where it starts until the over.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Week of gestation is between 31 and 36 weeks Not being exposed to a painful procedure at least 1 hour before the interventions At least 1 hour has passed since feeding Not taking analgesics and/or sedatives in the last 4 hours Body weight of 1000 grams or more Having mother's milk Not exceeding the 10th day of postnatal age Exclusion Criteria: Having ventilator support Having a congenital anomaly Using analgesic / narcotic analgesic drugs Continuous sedative treatment Having a congenital malformation that may cause asphyxia and affect respiration Having intracranial bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Negarin Akbari, PhD student
Organizational Affiliation
Istanbul un'vers'ty cerrahpasa-Istanbul,Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Golestan University of Medical Sciences
City
Gorgān
State/Province
Golestan
ZIP/Postal Code
017
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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