The Effect of a Musical Intervention on Stress Response to Venepuncture

University College Cork20 enrolled

Overview

Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress

The purpose of this study is to assess whether the use of music therapy as a non-pharmacological intervention around the time of venepuncture significantly decreases the stress response of a stable preterm neonate, as measured by salivary cortisol levels . The secondary aim of this study is to analyse the effect of music therapy on the EEG, and vital signs of the stable preterm neonate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pain Stress, Physiological

Interventions

Music therapyOTHER

The musical intervention will be played for ten minutes prior to venepuncture

Eligibility

Sex: ALLMin age: 23 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Infants born at less than 32 weeks gestational age (from 23+0 weeks' up to and including 31+6 weeks' gestational age) * Infants must now be \>32 weeks corrected gestational age * Infants who are medically stable and due to have routine venepuncture as part of their management plan Exclusion Criteria: * Inability to obtain informed consent from parent * Infants with known hearing impairment * Infants receiving sedative medications * Any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis * Infants with congenital abnormalities * Infants with known EEG abnormalities

Locations (1)

Cork University Maternity Hospital

Cork, Cork, Ireland

Outcomes

Primary Outcomes

Salivary cortisol levels

Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours

Time frame: BASELINE, 20 mins and 4 hours

Secondary Outcomes

Premature Infant Pain Profile (PIPP) score

Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score

Time frame: immediate

Changes in physiological parameters - Heart rate

Increase in heart rate

Time frame: 10 mins before venepuncture and 10 mins after

Changes in physiological parameters - respiration rate

Increase in respiration rate

Time frame: 10 mins before venepuncture and 10 mins after

Changes in physiological parameters - oxygen saturation

Decrease in oxygen saturation

Time frame: 10 mins before venepuncture and 10 mins after

Changes in physiological parameters - EEG

Altered EEG amplitude and Frequency.

Time frame: 10 mins before venepuncture and 10 mins after

Data from ClinicalTrials.gov

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