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Pain in Newborn Heel Blood Collection

Primary Purpose

Infant, Newborn, Disease, Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
White Noise
Yakson Touch
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Newborn, Disease

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

White Noise

Yakson touch

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2022
Last Updated
August 19, 2022
Sponsor
Ataturk University
Collaborators
MSc Reyhan YALÇIN, MSc Meral Güven
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1. Study Identification

Unique Protocol Identification Number
NCT05510271
Brief Title
Pain in Newborn Heel Blood Collection
Official Title
The Effect of White Noise and Therapeutic Touch on Pain in Newborn Heel Blood Collection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
Collaborators
MSc Reyhan YALÇIN, MSc Meral Güven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Disease, Pain, Acute

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
White Noise
Arm Type
Experimental
Arm Title
Yakson touch
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
White Noise
Intervention Description
Orhan OSMAN's song "Don't Let Your Baby Cry-2" from the "Kolik" album was used.
Intervention Type
Other
Intervention Name(s)
Yakson Touch
Intervention Description
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 Outcome Measure Information:
Title
The Newborn Infant Pain Scale (NIPS)
Description
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.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ataturk University
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain in Newborn Heel Blood Collection

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