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Clinical Trials/NCT05577793
NCT05577793
Completed
N/A

Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application in Turkey: A Randomized Controlled Study

Ayşe Belpınar1 site in 1 country124 target enrollmentApril 15, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm Infants
Sponsor
Ayşe Belpınar
Enrollment
124
Locations
1
Primary Endpoint
Neonatal Infant Pain Scale (NIPS)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.

Detailed Description

Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application. Design and Method: The study, which used a randomized controlled trial, included 124 preterm neonatal infants a gestational age of 28- 37 weeks and received nasal CPAP. The infants were treated with Mother's Voice, Therapeutic Touch, and Mother's Voice+ Therapeutic Touch. The Neonatal Infant Pain Scale (NIPS) and Premature Infant Comfort Scale (PICS) scores of the infants were measured before, during and after the nasal CPAP application.

Registry
clinicaltrials.gov
Start Date
April 15, 2019
End Date
August 14, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ayşe Belpınar
Responsible Party
Sponsor Investigator
Principal Investigator

Ayşe Belpınar

Lecturer

Bozok University

Eligibility Criteria

Inclusion Criteria

  • being checked in at Neonatal Intensive Care Unit
  • being in the gestational ages of 28 to 37 weeks
  • having nasal CPAP

Exclusion Criteria

  • having neurological disorders
  • having comorbidity
  • receiving sedation or analgesics
  • having congenital anomaly
  • receiving extra invasive procedures or surgical intervention
  • being diagnosed with hearing loss

Outcomes

Primary Outcomes

Neonatal Infant Pain Scale (NIPS)

Time Frame: 15 minutes

Neonatal Infant Pain Scale (NIPS) was developed by Lawrence et. al. in 1993 in order to assess intervention-related pain in term and preterm babies (Lawrence et al., 1993). The Turkish validity and reliability of the study was conducted in 1999 by Akdovan (Akdovan, 1999). NIPS has six sections on facial expression, crying, respiration state, movements of extremity, and being awake. All behavioral responses except for crying were given two separate scores (0-1 score). Three separate scores were assigned (0-1-2) to crying. The total scores were between 0-7. A high score showed that pain was more intense (Yilmaz \& Arikan, 2011). The Cronbach's a coefficients before, during, and after the intervention were found to be 0.95, 0.87, and 0.88, respectively, by Lawrence et al. (Lawrence et al., 1993).The Neonatal Infant Pain Scale (NIPS) score was evaluated and recorded before, during and 15 minutes after the application.

Premature Infant Comfort Scale (PICS)

Time Frame: 15 minutes

Premature Infant Comfort Scale (PICS) which was developed by Ambuel et. al. (Ambuel et al., 1992) in order to the measure pain and stress levels of 0-18-month-old children, was later adapted to 28-37-week-old premature infants by Monique et. al. in 2007 (Caljouw et al., 2007) The Premature Infant Comfort Scale assesses 7 parameters such as Awareness, Tranquility/Agitation, Respiration State (only supported by mechanical ventilation) or Crying (it was not assessed because it was scored only in children with spontaneous respiration), Physical Movement, Muscular Tonus, Facial Expressions and Average Cardiac Beat. The scale is 5-point Likert type. As the scale score increases, the comfort level decreases. The scores are between 35 and 7. Comfort decreases as it approaches 35 points, and increases as it approaches 7 points. (Küçük Alemdar \& Güdücü Tüfekci, 2015).Premature Infant Comfort Scale (PICS) score was evaluated and recorded before, during and 15 minutes after the application.

Study Sites (1)

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