NCT05281367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

10 days

First QC Date

January 18, 2022

Last Update Submit

March 15, 2022

Conditions

Pain, AcuteNeonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Heart rate during heel stick

    from 4 minutes before heel stick to 4 minute after heel stick

  • Respiratory rate

    From 4 minutes before heel stick to 4 minute after heel stick

  • Oxygen saturation

    From 4 minutes before heel stick to 4 minute after heel stick

Other Outcomes (1)

  • Crying time

    During procedure (During heel stick the total crying time was measured from where it starts until the over.)

Study Arms (4)

Breast milk odor group

EXPERIMENTAL

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.

Procedure: Breast milk odor group

Facilitated tucking group

EXPERIMENTAL

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.

Procedure: Facilitated tucking group

Non-nutritive sucking group

EXPERIMENTAL

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.

Procedure: Non-nutritive sucking group

control grup

EXPERIMENTAL

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.

Procedure: Control group

Interventions

Breast milk odor groupPROCEDURE

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).

Also known as: Breast milk odor
Breast milk odor group
Facilitated tucking groupPROCEDURE

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).

Facilitated tucking group
Non-nutritive sucking groupPROCEDURE

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).

Also known as: pacifire
Non-nutritive sucking group
Control groupPROCEDURE

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).

control grup

Eligibility Criteria

Age1 Day - 10 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golestan University of Medical Sciences

Gorgan, Golestan Province, 017, Iran

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Negarin Akbari, PhD student

    Istanbul un'vers'ty cerrahpasa-Istanbul,Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2022

First Posted

March 16, 2022

Study Start

December 15, 2021

Primary Completion

December 25, 2021

Study Completion

January 2, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)