Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application

Sponsor
Ayşe Belpınar (Other)
Overall Status
Completed
CT.gov ID
NCT05577793
Collaborator
(none)
124
1
4
16
7.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mother's Voice
  • Other: Therapeutic Touch
  • Other: Mother's Voice +Therapeutic Touch
  • Other: Control
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study used a randomized controlled trial. A parallel trial design was used describing three different experimental groups (Therapeutic Touch, Mother's Voice, and Therapeutic Touch+Mother's Voice) and a control group.This study used a randomized controlled trial. A parallel trial design was used describing three different experimental groups (Therapeutic Touch, Mother's Voice, and Therapeutic Touch+Mother's Voice) and a control group.
Masking:
Single (Participant)
Masking Description:
Because of the nature of the intervention, double-blinding was not possible in this study.
Primary Purpose:
Supportive Care
Official Title:
Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application in Turkey: A Randomized Controlled Study
Actual Study Start Date :
Apr 15, 2019
Actual Primary Completion Date :
Oct 15, 2019
Actual Study Completion Date :
Aug 14, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mother's Voice

The mothers were asked to sing lullabies, and their voices were recorded in a quiet environment. Which lullaby they would sing was left to the mothers' discretion, and the audio recording process took an average of 2-3 minutes. The voice recordings taken were applied for a total of 15 minutes before, during and after the nasal CPAP application.The NIPS and PICS scores were evaluated and recorded before, during and after the application.

Other: Therapeutic Touch
Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Other Names:
  • Therapeutic Touch Group
  • Other: Mother's Voice +Therapeutic Touch
    Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
    Other Names:
  • Mother's Voice +Therapeutic Touch Group
  • Other: Control
    The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
    Other Names:
  • Control Group
  • Experimental: Therapeutic Touch

    Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.

    Other: Mother's Voice
    The audio recording was made to listen to the baby for 15 minutes during the nasal CPAP application. The NIPS and PICS scores were evaluated and recorded before, during and after the application.
    Other Names:
  • Mother's Voice Group
  • Other: Mother's Voice +Therapeutic Touch
    Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
    Other Names:
  • Mother's Voice +Therapeutic Touch Group
  • Other: Control
    The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
    Other Names:
  • Control Group
  • Experimental: Mother's Voice+Therapeutic Touch

    Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.

    Other: Mother's Voice
    The audio recording was made to listen to the baby for 15 minutes during the nasal CPAP application. The NIPS and PICS scores were evaluated and recorded before, during and after the application.
    Other Names:
  • Mother's Voice Group
  • Other: Therapeutic Touch
    Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
    Other Names:
  • Therapeutic Touch Group
  • Other: Control
    The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
    Other Names:
  • Control Group
  • No Intervention: Control

    The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.

    Outcome Measures

    Primary Outcome Measures

    1. Neonatal Infant Pain Scale (NIPS) [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.

    2. Premature Infant Comfort Scale (PICS) [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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cengiz Gökçek Gynecology, Obstetrics and Pediatrics Hospital Gaziantep Turkey 27060

    Sponsors and Collaborators

    • Ayşe Belpınar

    Investigators

    • Principal Investigator: Ayşe Belpınar, Msc, Bozok University
    • Principal Investigator: Emriye Hilal Yayan, Phd, Inonu University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayşe Belpınar, Lecturer, Bozok University
    ClinicalTrials.gov Identifier:
    NCT05577793
    Other Study ID Numbers:
    • ABelpinar
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 13, 2022
    Last Verified:
    Oct 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
    Keywords provided by Ayşe Belpınar, Lecturer, Bozok University

    Study Results

    No Results Posted as of Oct 13, 2022