The Effect of a Musical Intervention on Stress Response to Venepuncture

Pain Clinical Trial

Official title:

The Effect of a Musical Intervention on Stress Response to Venepuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028844
• Other study ID #: ED/01/16UCC
• Status: Completed
• Phase: N/A
• First received: January 9, 2017
• Last updated: January 18, 2017
• Start date: April 2016
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Stress, Physiological

Intervention

Other:
• Music therapy
The musical intervention will be played for ten minutes prior to venepuncture

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary cortisol levels	Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours	BASELINE, 20 mins and 4 hours
Secondary	Premature Infant Pain Profile (PIPP) score	Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score	immediate
Secondary	Changes in physiological parameters - Heart rate	Increase in heart rate	10 mins before venepuncture and 10 mins after
Secondary	Changes in physiological parameters - respiration rate	Increase in respiration rate	10 mins before venepuncture and 10 mins after
Secondary	Changes in physiological parameters - oxygen saturation	Decrease in oxygen saturation	10 mins before venepuncture and 10 mins after
Secondary	Changes in physiological parameters - EEG	Altered EEG amplitude and Frequency.	10 mins before venepuncture and 10 mins after