The Effect of a Musical Intervention on Stress Response t... | NCT03028844

Studies
The Effect of a Musical Intervention on Stress Response to Venepuncture

NCT03028844

Sponsor

University College Cork

Status

Completed

Last Update Posted

Jan 23, 2017Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pain
Stress, Physiological

Interventions

Music therapy

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Jan 9, 2017

First Submission Date that Met QC Criteria

Jan 18, 2017

First Posted Date

Jan 23, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2017

Last Update Posted Date

Jan 23, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sucrose alone	No Intervention	These infants will receive an oral sucrose solution ("Sweetease") only prior to venepuncture
Music intervention plus sucrose	Experimental	These infants will receive both oral sucrose solution and music therapy prior to venepuncture.	Other: Music therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music therapy	Other	The musical intervention will be played for ten minutes prior to venepuncture	Music intervention plus sucrose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Salivary cortisol levels	Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours	BASELINE, 20 mins and 4 hours

Secondary Outcomes

Measure	Description	Time Frame
Premature Infant Pain Profile (PIPP) score	Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score	immediate
Changes in physiological parameters - Heart rate	Increase in heart rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Weeks

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cork University Maternity Hospital		Cork	Cork		Ireland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D047928	Premature Birth

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007752	Obstetric Labor, Premature

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided