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Completed

NCT Number: NCT03028844

The Effect of a Musical Intervention on Stress Response to Venepuncture

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

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Key information

Conditions

Pain Female Urogenital Diseases and Pregnancy Complications Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Stress, Physiological Urogenital Diseases

Age range

23 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cork University Maternity Hospital

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy

Other

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

Primary outcomes

  1. Salivary cortisol levels

    Time frame: BASELINE, 20 mins and 4 hours

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

Secondary outcomes

  1. Premature Infant Pain Profile (PIPP) score

    Time frame: immediate

    Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score

  2. Changes in physiological parameters - Heart rate

    Time frame: 10 mins before venepuncture and 10 mins after

    Increase in heart rate

  3. Changes in physiological parameters - respiration rate

    Time frame: 10 mins before venepuncture and 10 mins after

    Increase in respiration rate

  4. Changes in physiological parameters - oxygen saturation

    Time frame: 10 mins before venepuncture and 10 mins after

    Decrease in oxygen saturation

  5. Changes in physiological parameters - EEG

    Time frame: 10 mins before venepuncture and 10 mins after

    Altered EEG amplitude and Frequency.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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