The Effects of the Maternal Voice Combined With Lullaby to Reduce the Heel Puncture Pain in Prete… (NCT05043337) | Clinical Trial Compass
CompletedNot Applicable
The Effects of the Maternal Voice Combined With Lullaby to Reduce the Heel Puncture Pain in Preterm Infant
Taiwan120 participantsStarted 2021-10-31
Plain-language summary
In Taiwan, 183,254 newborns were born in 2018, with preterm births accounting for about 8-10%. The preterm infant required frequent medical treatment from birth to hospital discharge, which is accompanied by a painful process that can cause unstable vital signs in the short term and may affect their biological and psychological development in the long term. Music therapy is a non-invasive and easily accessible intervention, can be used to reduce the discomfort of painful stimulation during hospitalization of preterm infants. Music therapies in this text are the mother's voice and lullabies.
Who can participate
Age range2 Days – 2 Days
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Babies born alive before 37 weeks of pregnancy.
✓. Infants who were required to receive heel lance procedure every 8 hours after physicians' diagnoses.
✓. Those who can record the mother's voice and whose mother can read Chinese.
Exclusion criteria
✕. Abnormal ear appearance, chromosomal abnormalities, congenital or acquired infections.
✕. Postnatal patients whose mothers are not in the postnatal ward, e.g., those who need to be admitted to the intensive care unit due to their medical condition.
✕. Patients used high-frequency oscillatory ventilators, because the high-frequency oscillatory ventilator gives 600 oscillatory breaths per minute and it is not possible to evaluate whether the study subjects can effectively listen to the interventions given, so they were excluded.
✕. Mothers who were unable to complete the recording because of emotional ups and downs during the recording process.
✕. Mothers who smoked, drank alcohol or used illegal drugs during pregnancy.
What they're measuring
1
Heart rate
Timeframe: Change from Baseline Heart rate at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure
2
Respiratory rate
Timeframe: Change from Baseline Respiratory rate at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure
3
Oxygen Saturation
Timeframe: Change from Baseline Saturation of Peripheral Oxygen at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure
4
Respond of Pain
Timeframe: Change from Baseline Pain at 3 minutes before, during, and at 1st、3rd and 10th minute after heel lance procedure