The Effect of a Musical Intervention on Stress Response to Venepuncture

January 18, 2017 updated by: Dr. Gene Dempsey, University College Cork
Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Cork University Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Sucrose alone
These infants will receive an oral sucrose solution ("Sweetease") only prior to venepuncture
EXPERIMENTAL: Music intervention plus sucrose
These infants will receive both oral sucrose solution and music therapy prior to venepuncture.
Other: Music therapy
The musical intervention will be played for ten minutes prior to venepuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cortisol levels
Time Frame: BASELINE, 20 mins and 4 hours
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
Time Frame: immediate
Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score
immediate
Changes in physiological parameters - Heart rate
Time Frame: 10 mins before venepuncture and 10 mins after
Increase in heart rate
10 mins before venepuncture and 10 mins after
Changes in physiological parameters - respiration rate
Time Frame: 10 mins before venepuncture and 10 mins after
Increase in respiration rate
10 mins before venepuncture and 10 mins after
Changes in physiological parameters - oxygen saturation
Time Frame: 10 mins before venepuncture and 10 mins after
Decrease in oxygen saturation
10 mins before venepuncture and 10 mins after
Changes in physiological parameters - EEG
Time Frame: 10 mins before venepuncture and 10 mins after
Altered EEG amplitude and Frequency.
10 mins before venepuncture and 10 mins after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ED/01/16UCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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