The Effect of Music, White Noise and Heart Sound on Neonatal Pain

NCT05828420 | Completed DMC

• 1 other identifier: bdonmez@iuc.edu.tr
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Infants are exposed to many painful procedures during their stay in the Neonatal Intensive Care Unit (NICU). Some epidemiological studies report that infants experience an average of 7.5-14 painful procedures per day per infant during the first 14 days of their hospitalization. The most significant problem encountered in understanding pain in infants is the lack of verbal expression of pain. Newborns express their pain with nonverbal behavioral expressions. Therefore, any pain assessment is based on the ability to recognize the pain symptoms of others. The pain experienced may cause physiological imbalances and abnormalities in brain development and stress response in infants in the short and long term. It can negatively affect family-infant communication, as well as cause emotional and psychosomatic problems later in life. Today, music therapy has positive effects on reducing stress, reducing pain, oxygen saturation level, and peak heart rate values in providing individualized developmental care of the infant in neonatal intensive care units. Heart sound, babies hear the mother's heart sound the most during the intrauterine period in the womb. Therefore, when babies hear the sound, they are familiar with in the womb, they will feel safe and a sense of relaxation will occur in the baby. Several studies have proven that playing heartbeat sounds to newborn babies can positively affect their physiological indicators, feeding, length of hospital stay and pain outcomes. The current literature shows that the presence of rhythmic sound can positively affect the neurobehavioral development of the infant and reduce pain. Rhythmic sounds have healing/positive effects on newborns; listening to white noise reduces preterms' pain scores, stabilizes vital signs, and plays an active role in preterms' sleep-wake period. In line with all this information, this study was carried out as a randomized controlled experimental study in order to determine the effects of music played during heel spear application, white noise and heart sound in infants.

Conditions

Neonatal; Pain

Keywords

Music; Neonatal; pain; white noise; heel lance; heart sound

Outcome Measures

Primary Outcomes (1)

• NIAPAS pain score

  The Neonatal Infant Acute Pain Assessment Scale (NIAPAS) was used to measure the pain of newborns. The score that can be obtained from scoring the indicators is between 0-18. The indicators can be scored with 2 (0,1), 3 (0,1,2) or 4 (0,1,2,3) grades. Painful procedures are evaluated in three stages. Pain intensity is classified as mild (0-5), moderate (6-9), and severe pain (10-18).

  2 year

Secondary Outcomes (1)

• Crying time

  2 year

Study Arms (3)

The pain effect of listening to white noise on newborn babies

EXPERIMENTAL

Each baby was listened to white noise 10 minutes before, during and 20 minutes after the painful attempt.

Other: White noise

The pain effect of listening to heart sound on newborn babies

EXPERIMENTAL

Each baby listened to heart sounds at an average rate of 70 beats 10 minutes before, during and 20 minutes after the painful procedure.

Other: Heart sound

The pain effect of listening to music on newborn babies

EXPERIMENTAL

Each baby was listened to the music that the mother listened to the most during pregnancy restriction 10 minutes before, during and after the painful attempt.

Other: Music

Interventions

White noise OTHER

Each baby was listened to white noise 10 minutes before, during and 20 minutes after the painful attempt.

The pain effect of listening to white noise on newborn babies

Heart sound OTHER

Each baby listened to heart sounds at an average rate of 70 beats 10 minutes before, during and 20 minutes after the painful procedure.

The pain effect of listening to heart sound on newborn babies

Music OTHER

Each baby was listened to the music that the mother listened to the most during pregnancy restriction 10 minutes before, during and after the painful attempt.

The pain effect of listening to music on newborn babies

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Having a 28-42 weeks preterm or term newborn
• No sedative or analgesic given in the last 6 hours

You may not qualify if:

• Presence of intracranial bleeding
• Having cerebral hypoxic ischemia
• Babies whose blood cannot be drawn on the first try

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Heart Sounds; Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Birsen Mutlu

  İstanbul Universty-Cerrahpaşa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 25, 2023
• Study Start: October 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 27, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)