Pain in Newborn Heel Blood Collection

NCT05510271 | Completed

• 1 other identifier: ATA.0.01.00/124
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infant, Newborn, Disease; Pain, Acute

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

White Noise

EXPERIMENTAL

Other: White Noise

Yakson touch

EXPERIMENTAL

Other: Yakson Touch

Control

NO INTERVENTION

Interventions

White Noise OTHER

Orhan OSMAN's song "Don't Let Your Baby Cry-2" from the "Kolik" album was used.

White Noise

Yakson Touch OTHER

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.

Yakson touch

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• newborns whose heel blood cannot be taken at once

Sponsors & Collaborators

• Ataturk University: lead
• MSc Reyhan YALÇIN: collaborator
• MSc Meral Güven: collaborator

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Disease; Acute Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: May 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)