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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05510271
Other study ID # ATA.0.01.00/124
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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