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Completed

NCT Number: NCT05281367

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Neonatal Intensive Care Unit Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golestan University of Medical Sciences

Gorgan, Golestan Province, 017, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast milk odor group

Procedure

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).

Other names: Breast milk odor

Facilitated tucking group

Procedure

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

Procedure

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).

Other names: pacifire

Control Group

Procedure

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 outcomes

  1. Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)

    Time frame: Pain was measured at 1 minutes before 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.

  2. Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)

    Time frame: Pain was measured at 2 minutes before 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.

  3. Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)

    Time frame: Pain was measured at 3 minutes before 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.

  4. Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)

    Time frame: Pain was measured during 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.

  5. Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)

    Time frame: Pain was measured at 1 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.

  6. Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)

    Time frame: Pain was measured at 2 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.

  7. Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)

    Time frame: 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 outcomes

  1. Heart rate during heel stick

    Time frame: 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).

  2. Respiratory rate

    Time frame: 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).

  3. Oxygen saturation

    Time frame: 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).

Other outcomes

  1. Crying time

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

    The researcher recorded the crying time in second (sec) during heel stick.

Sponsors and collaborators

Lead sponsor

Negarin Akbari

Other

Registry information

Official study title

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

Acronym: (pain)

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 16, 2022
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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