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Completed

NCT Number: NCT04144543

Non-pharmacological Pain Management in Term Neonates

A randomised clinical trial in a single centre. This study was performed to compare the effect of white noise, facilitated tucking, and their concerted application during heel-stick sampling on pain in term babies.

The study was conducted on 90 babies. Using stratification and blocking method, 30 babies were included in the white noise group (1st Group), 30 in facilitated tucking group (2nd Group), and 30 in white noise + facilitated tucking group (3rd Group). Pain scores of the babies in all groups before, during, and after the procedure were evaluated by two nurses independent from each other using Neonatal Infant Pain Scale (NIPS).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çankırı Karatekin Üniversitesi

Çankiri, 18200, Turkey (Türkiye)

About this study

Aims and objectives: This study was performed to compare the effect of white noise, facilitated tucking, and their concerted application during heel-stick sampling on pain in term babies.

Design: A randomised clinical trial in a single centre. Methods: The study sample size was determined by the free-software G* Power. Based on the power analysis performed prior to the study in order to determine the number of babies to be included in the sample group (with β=0.14087 and α=0.05 risk, Power=0.85913), according to the study by Karakoc and Turker (2014), it was found that 27 neonates should be included in each group. The study was conducted on 90 babies, between July 1, 2017 - August 9, 2017. Using stratification and blocking method, 30 babies were included in the white noise group (1st Group), 30 in facilitated tucking group (2nd Group), and 30 in white noise + facilitated tucking group (3rd Group). Pain scores of the babies in all groups before, during, and after the procedure were evaluated by two nurses independent from each other using Neonatal Infant Pain Scale (NIPS).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being term baby
  • Being with mother
  • Being a healthy baby
  • Being able fed orally
  • Being fed at least half an hour before the procedure
  • Being able to draw blood at the first try (since the pain level will change on the second try)
  • Agreed to participate in the study and gave verbal consent were included in the study.

Exclusion criteria

  • Having received analgesics and/or sedatives within the last 24 hours
  • Having any complications that prevent pain evaluation (e.g. intracranial hemorrhage, neuromotor growth retardation, etc.)
  • Having undergone any painful procedures within the last hour (e.g. blood drawing, aspiration, ophthalmologic examination, etc.)
  • Prior history of surgery
  • Being connected to mechanical ventilator

Treatment and study plan

White Noise

Other

The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. The baby was exposed to white noise for 2 minutes before the procedure.

Facilitated Tucking

Other

The baby's arms and legs were held in flexed positions close to the midline of the torso in sidelying position, so the baby was able to move his/her extremities. The baby was held in facilitated tucking position for one minute before the procedure.

White Noise+Facilitated Tucking

Other

The baby was exposed to white noise for 1 minute before the procedure. The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. At the second minute, when the white noise still continued to play, facilitated tucking was performed at the same time and the baby continued to listen to the white noise for 1 minute while in facilitated tucking position.

Primary outcomes

  1. Pain severity (scores)

    Time frame: 2 MONTHS

    Pain was evaluated separately by NIPS by two individuals, one investigator and one nursing nurse. The scores given by the investigator and the nurse were used to determine pain scores before, during and after heel blood collection. Pain severity was expressed as mean score NIPS.Neonatal Infant Pain Scale (NIPS) was used in the evaluation of the pain of the neonates. This scale was developed by Lawrence et al. (1993). The validity and reliability of the Turkish version of the test were assessed by Akdovan (1999). There are six variables in the scale. These are baby's breathing pattern, wakefulness, crying, facial movements and arm and leg movements. These variables are scored between 0-1. Only crying is scored between 0-2. The total score is between 0-7. The resulting score is directly proportional to the severity of the pain. That is, as the score increases, the severity of the pain increases (Akdovan, 1999). The study was completed with 90 infants.

Secondary outcomes

  1. Crying time

    Time frame: 2 MONTHS

    The researcher recorded the crying time in second (sec) during and after heel blood collection. The study was completed with 90 infants.

Other outcomes

  1. Physiological Changes: Heart rate

    Time frame: 2 MONTHS

    The pulse oximetry probe was attached to a non-heeled foot to measure heart in second (sec) before, during and after heel blood collection in each infant. The study was completed with 90 infants.

  2. Physiological Changes: Oxygen saturation

    Time frame: 2 MONTHS

    The pulse oximetry probe was attached to a non-heeled foot to measure oxygen saturation in percent (%) before, during and after heel blood collection in each infant. The study was completed with 90 infants.

  3. Physiological Changes: Respiration

    Time frame: 2 MONTHS

    The researcher recorded the respiration in minute (min) before and after heel blood collection. The study was completed with 90 infants.

Sponsors and collaborators

Lead sponsor

Çankırı Karatekin University

Other

Registry information

Official study title

Experimental Randomized Study: The Effect of White Noise and Facilitated Tucking Applications During Heel-Stick Sampling on Pain in Term Babies

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2019
Registry last updated
Oct 30, 2019

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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