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Completed

NCT Number: NCT05510271

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.

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Key information

Conditions

Infant, Newborn, Disease Acute Pain Disease Neurologic Manifestations Pain Pain, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

White Noise

Other

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

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.

Primary outcomes

  1. The Newborn Infant Pain Scale (NIPS)

    Time frame: 12 week

    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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • MSc Meral Güven
  • MSc Reyhan YALÇIN

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2022
Registry last updated
Feb 6, 2024

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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