Pain in Newborn Heel Blood Collection

The Effect of White Noise and Therapeutic Touch on Pain in Newborn Heel Blood Collection

This study was conducted to evaluate the effect of white noise and therapeutic touch on pain in newborn heel blood collection.Questions including the sex of the newborns, postnatal age, gestational age, birth weight, height, head and chest circumference, feeding style, nutritional status in the last half hour, and previous heel blood collection were collected with the "Information Form".The Newborn Infant Pain Scale (NIPS) was used to evaluate the pain levels of newborns.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Infant, Newborn, Disease
• Intervention / Treatment: Other: White Noise; Other: Yakson Touch

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 9 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• gestational week 37 and above,
• fasting time < 1 hour,
• without comorbidity and congenital anomalies,
• not receiving oxygen or mechanical respiratory support,
• no analgesic sedation before the procedure
• neonates with stable physiological findings before the procedure

Exclusion Criteria:

• newborns whose heel blood cannot be taken at once

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: White Noise	Other: White Noise; Orhan OSMAN's song "Don't Let Your Baby Cry-2" from the "Kolik" album was used.
Experimental: Yakson touch	Other: Yakson Touch; In order to transfer the Ki energy to the baby, he took a deep breath and gathered the universal energy in his palms, intending the baby's well-being and healing. The researcher applied the Yakson touch by covering the abdomen and chest of the newborn with his right hand (dominant hand) while the newborn was in the supine position, and supported the baby's back and hips with his left hand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Newborn Infant Pain Scale (NIPS)	The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.	12 week

Collaborators and Investigators

• Sponsor: Ataturk University
• Collaborators: MSc Reyhan YALÇIN; MSc Meral Güven

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Infant, Newborn, Diseases
• Other Study ID Numbers: ATA.0.01.00/124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No