The Effect of a Musical Intervention on Stress Response to Venepuncture

NCT03028844 | Completed

• 1 other identifier: ED/01/16UCC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Stress, Physiological

Keywords

Neonate; preterm; pain; music; EEG; venepuncture

Outcome Measures

Primary Outcomes (1)

• Salivary cortisol levels

  Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours

  BASELINE, 20 mins and 4 hours

Secondary Outcomes (5)

• Premature Infant Pain Profile (PIPP) score

  immediate

• Changes in physiological parameters - Heart rate

  10 mins before venepuncture and 10 mins after

• Changes in physiological parameters - respiration rate

  10 mins before venepuncture and 10 mins after

• Changes in physiological parameters - oxygen saturation

  10 mins before venepuncture and 10 mins after

• Changes in physiological parameters - EEG

  10 mins before venepuncture and 10 mins after

Study Arms (2)

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

Music therapy OTHER

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

Music intervention plus sucrose

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Maternity Hospital

Cork, Cork, Ireland

Location

MeSH Terms

Conditions

Pain; Premature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 23, 2017
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)