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

NCT ID: NCT05578079

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-14

Study Completion Date

2023-04-25

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

No music will be played to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention 1

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.

Group Type ACTIVE_COMPARATOR

Music

Intervention Type OTHER

Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.

Intervention 2

The Intervention-2 group will listen to lullaby.

Group Type ACTIVE_COMPARATOR

Music

Intervention Type OTHER

Intervention-2 group will listen to lullaby.

Interventions

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Music

Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.

Intervention Type OTHER

Music

Intervention-2 group will listen to lullaby.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

32 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

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Pınar Dogan

Research Ass.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Defne ENGUR, Assoc.Prof.

Role: STUDY_CHAIR

Tepecik Research and Training Hospital

Locations

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Tepecik Research and Training Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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05

Identifier Type: -

Identifier Source: org_study_id

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