Pain, Stress, Physiological
Conditions
Keywords
Neonate, preterm, pain, music, EEG, venepuncture
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.
Interventions
OTHERMusic therapy
The musical intervention will be played for ten minutes prior to venepuncture
Sponsors
University College Cork
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 32 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary cortisol levels | BASELINE, 20 mins and 4 hours | Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Premature Infant Pain Profile (PIPP) score | immediate | Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score |
| Changes in physiological parameters - Heart rate | 10 mins before venepuncture and 10 mins after | Increase in heart rate |
| Changes in physiological parameters - respiration rate | 10 mins before venepuncture and 10 mins after | Increase in respiration rate |
| Changes in physiological parameters - oxygen saturation | 10 mins before venepuncture and 10 mins after | Decrease in oxygen saturation |
| Changes in physiological parameters - EEG | 10 mins before venepuncture and 10 mins after | Altered EEG amplitude and Frequency. |
Countries
Ireland
Outcome results
None listed