The Effect of a Musical Intervention on Stress Response to Venepuncture

University College Cork (UCC)

Status: Completed

Conditions: Stress, Physiological; Pain

Treatments: Other: Music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03028844

ED/01/16UCC

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 23 to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sucrose alone

No Intervention group

Description:

These infants will receive an oral sucrose solution ("Sweetease") only prior to venepuncture

Music intervention plus sucrose

Experimental group

Description:

These infants will receive both oral sucrose solution and music therapy prior to venepuncture.

Treatment:

Other: Music therapy