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Pain in Newborn Heel Blood Collection

Sponsor
Ataturk University (Other)
Overall Status
Completed
CT.gov ID
NCT05510271
Collaborator
MSc Reyhan YALÇIN (Other), MSc Meral Güven (Other)
65
Enrollment
1
Location
3
Arms
3.5
Actual Duration (Months)
18.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: White Noise
  • Other: Yakson Touch
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of White Noise and Therapeutic Touch on Pain in Newborn Heel Blood Collection
Actual Study Start Date :
May 1, 2022
Actual Primary Completion Date :
Jul 30, 2022
Actual Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
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.
No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. The Newborn Infant Pain Scale (NIPS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
37 Weeks to 42 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ataturk University Erzurum Turkey 25240

Sponsors and Collaborators

  • Ataturk University
  • MSc Reyhan YALÇIN
  • MSc Meral Güven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Türkan Kadiroğlu, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT05510271
Other Study ID Numbers:
  • ATA.0.01.00/124
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infant, Newborn, Diseases
Acute Pain

Study Results

No Results Posted as of Aug 22, 2022