NCT05578079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 14, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

October 10, 2022

Last Update Submit

July 21, 2023

Conditions

Pain

Keywords

PrematurePainMusic

Outcome Measures

Primary Outcomes (12)

  • Baby's heart rate

    The baby's pulse rate will be measured.

    2 minutes before collecting heel blood

  • Baby's heart rate

    The baby's pulse rate will be measured.

    During heel blood collection

  • Baby's heart rate

    The baby's pulse rate will be measured.

    2 minutes after collecting heel blood

  • Baby's respiratory rate

    The baby's respiratory rate will be measured.

    2 minutes before collecting heel blood

  • Baby's respiratory rate

    The baby's respiratory rate will be measured.

    During heel blood collection

  • Baby's respiratory rate

    The baby's respiratory rate will be measured.

    2 minutes after collecting heel blood

  • Baby's oxygen saturation

    The baby's oxygen saturation will be measured.

    2 minutes before collecting heel blood

  • Baby's oxygen saturation

    The baby's oxygen saturation will be measured.

    During heel blood collection

  • Baby's oxygen saturation

    The baby's oxygen saturation will be measured.

    2 minutes after collecting heel blood

  • Premature Infant Pain Profile (PIPP)

    PIPP scores will be evaluated separately by two experts in the field.

    2 minutes before collecting heel blood

  • Premature Infant Pain Profile (PIPP)

    PIPP scores will be evaluated separately by two experts in the field.

    During heel blood collection

  • Premature Infant Pain Profile (PIPP)

    PIPP scores will be evaluated separately by two experts in the field.

    2 minutes after collecting heel blood

Study Arms (3)

Control group

NO INTERVENTION

No music will be played to the control group.

Intervention 1

ACTIVE COMPARATOR

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.

Other: Music

Intervention 2

ACTIVE COMPARATOR

The Intervention-2 group will listen to lullaby.

Other: Music

Interventions

MusicOTHER

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

Intervention 1

Eligibility Criteria

Age32 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Birth weight below 2500 g
  • Receiving analgesics or sedatives
  • Need for mechanical ventilation
  • Heel blood collection is not successful in the first time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Research and Training Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainPremature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Defne ENGUR, Assoc.Prof.

    Tepecik Research and Training Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Ass.

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

October 14, 2022

Primary Completion

April 25, 2023

Study Completion

April 25, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

TU(1)