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The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music
Music
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Premature, Pain, Music

Eligibility Criteria

32 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Families being voluntary to participate in the study
  • Gestational age is 32-37 weeks
  • Not taking analgesics or sedatives
  • The baby's condition is stable

Exclusion Criteria:

  • Gestational age less than 32 weeks or greater than 37 weeks
  • Taking analgesics or sedatives
  • The baby's condition is unstable

Sites / Locations

  • Tepecik Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control group

Intervention 1

Intervention 2

Arm Description

No music will be played to the control group.

The Intervention-1 group will listen to the music which determined by the researchers by examining the literature (DOI: 10.4274/jpr.24892). The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach.

The Intervention-2 group will listen to lullaby.

Outcomes

Primary Outcome Measures

Baby's heart rate
The baby's pulse rate will be measured.
Baby's heart rate
The baby's pulse rate will be measured.
Baby's heart rate
The baby's pulse rate will be measured.
Baby's respiratory rate
The baby's respiratory rate will be measured.
Baby's respiratory rate
The baby's respiratory rate will be measured.
Baby's respiratory rate
The baby's respiratory rate will be measured.
Baby's oxygen saturation
The baby's oxygen saturation will be measured.
Baby's oxygen saturation
The baby's oxygen saturation will be measured.
Baby's oxygen saturation
The baby's oxygen saturation will be measured.
Premature Infant Pain Profile (PIPP)
PIPP scores will be evaluated separately by two experts in the field.
Premature Infant Pain Profile (PIPP)
PIPP scores will be evaluated separately by two experts in the field.
Premature Infant Pain Profile (PIPP)
PIPP scores will be evaluated separately by two experts in the field.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2022
Last Updated
July 21, 2023
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT05578079
Brief Title
The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants
Official Title
The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants: A Double-Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
April 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

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
Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby. Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.
Detailed Description
Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby. Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Premature, Pain, Music

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
No music will be played to the control group.
Arm Title
Intervention 1
Arm Type
Active Comparator
Arm Description
The Intervention-1 group will listen to the music which determined by the researchers by examining the literature (DOI: 10.4274/jpr.24892). The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach.
Arm Title
Intervention 2
Arm Type
Active Comparator
Arm Description
The Intervention-2 group will listen to lullaby.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Intervention-2 group will listen to lullaby.
Primary Outcome Measure Information:
Title
Baby's heart rate
Description
The baby's pulse rate will be measured.
Time Frame
2 minutes before collecting heel blood
Title
Baby's heart rate
Description
The baby's pulse rate will be measured.
Time Frame
During heel blood collection
Title
Baby's heart rate
Description
The baby's pulse rate will be measured.
Time Frame
2 minutes after collecting heel blood
Title
Baby's respiratory rate
Description
The baby's respiratory rate will be measured.
Time Frame
2 minutes before collecting heel blood
Title
Baby's respiratory rate
Description
The baby's respiratory rate will be measured.
Time Frame
During heel blood collection
Title
Baby's respiratory rate
Description
The baby's respiratory rate will be measured.
Time Frame
2 minutes after collecting heel blood
Title
Baby's oxygen saturation
Description
The baby's oxygen saturation will be measured.
Time Frame
2 minutes before collecting heel blood
Title
Baby's oxygen saturation
Description
The baby's oxygen saturation will be measured.
Time Frame
During heel blood collection
Title
Baby's oxygen saturation
Description
The baby's oxygen saturation will be measured.
Time Frame
2 minutes after collecting heel blood
Title
Premature Infant Pain Profile (PIPP)
Description
PIPP scores will be evaluated separately by two experts in the field.
Time Frame
2 minutes before collecting heel blood
Title
Premature Infant Pain Profile (PIPP)
Description
PIPP scores will be evaluated separately by two experts in the field.
Time Frame
During heel blood collection
Title
Premature Infant Pain Profile (PIPP)
Description
PIPP scores will be evaluated separately by two experts in the field.
Time Frame
2 minutes after collecting heel blood

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent being voluntary to participate in the study Being born at 32-36+6 gestastional week The baby's condition is stable Having passed hearing test Having not congenital malformation Exclusion Criteria: Birth weight below 2500 g Receiving analgesics or sedatives Need for mechanical ventilation Heel blood collection is not successful in the first time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Defne ENGUR, Assoc.Prof.
Organizational Affiliation
Tepecik Research and Training Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tepecik Research and Training Hospital
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants

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