Pain in Newborn Heel Blood Collection

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05510271
• Other study ID #: ATA.0.01.00/124
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: February 2024
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 37 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Infant, Newborn, Disease
• Infant, Newborn, Diseases
• Pain, Acute

Intervention

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

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (3)

Lead Sponsor	Collaborator
Ataturk University	MSc Meral Güven, MSc Reyhan YALÇIN

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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