The Effect of a Musical Intervention on Stress Response to Venepuncture

NCT ID: NCT03028844

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-11-30

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.

Conditions

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Pain Stress, Physiological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sucrose alone

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Music intervention plus sucrose

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

Group Type EXPERIMENTAL

Music therapy

Intervention Type OTHER

The musical intervention will be played for ten minutes prior to venepuncture

Interventions

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Music therapy

The musical intervention will be played for ten minutes prior to venepuncture

Intervention Type OTHER

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
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gene Dempsey

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cork University Maternity Hospital

Cork, Cork, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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ED/01/16UCC

Identifier Type: -

Identifier Source: org_study_id

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