The Effect of a Musical Intervention on Stress Response to Venepuncture

Not Applicable

Completed

• Conditions: Stress, Physiological; Pain
• Interventions: Other: Music therapy

• Registration Number: NCT03028844
• Lead Sponsor: University College Cork

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2016-04
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Music intervention plus sucrose	Music therapy	These infants will receive both oral sucrose solution and music therapy prior to venepuncture.

Primary Outcome Measures

Name	Time	Method
Salivary cortisol levels	BASELINE, 20 mins and 4 hours	Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cork University Maternity Hospital; 🇮🇪 Cork, Ireland