The Effect of a Musical Intervention on Stress Response to Venepuncture

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

Detailed Description
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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.

Official Title
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The Effect of a Musical Intervention on Stress Response to Venepuncture

Conditions
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Pain, Stress, Physiological

Intervention / Treatment
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* Other: Music therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sucrose alone<br>These infants will receive an oral sucrose solution (Sweetease) only prior to venepuncture | |
| Experimental: Music intervention plus sucrose<br>These infants will receive both oral sucrose solution and music therapy prior to venepuncture. | Other: Music therapy<br>* The musical intervention will be played for ten minutes prior to venepuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cortisol levels | Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours | BASELINE, 20 mins and 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature Infant Pain Profile (PIPP) score | Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score | immediate | 
| Changes in physiological parameters - Heart rate | Increase in heart rate | 10 mins before venepuncture and 10 mins after | 
| Changes in physiological parameters - respiration rate | Increase in respiration rate | 10 mins before venepuncture and 10 mins after | 
| Changes in physiological parameters - oxygen saturation | Decrease in oxygen saturation | 10 mins before venepuncture and 10 mins after | 
| Changes in physiological parameters - EEG | Altered EEG amplitude and Frequency. | 10 mins before venepuncture and 10 mins after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonate, preterm, pain, music, EEG, venepuncture