Preterm Birth Clinical Trial
Official title:
Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures
NCT number | NCT04762004 |
Other study ID # | 90.513 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 7, 2018 |
Est. completion date | July 1, 2020 |
Verified date | February 2021 |
Source | University of Geneva, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Preterm infants undergo early separation from parents and are exposed to frequent painful clinical procedures, with resultant short- and long-term effects on their neurodevelopment. We aimed to establish whether the mother's voice could provide an effective and safe analgesia for preterm infants and whether endogenous oxytocin (OXT) could be linked to pain modulation. Twenty preterm infants were exposed to three conditions-mother's live voice (speaking or singing) and standard care-in random order during a painful procedure. OXT levels (pg/mL) in saliva and plasma cortisol levels were quantified, and the Premature Infant Pain Profile (PIPP) was blindly coded by trained psychologists.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 1, 2020 |
Est. primary completion date | May 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 29 Weeks to 37 Weeks |
Eligibility | Inclusion Criteria: - age >29 weeks gestational age at birth, - weight >1000 g - stable medical condition (absence of mechanical ventilation, no additional oxygen) Exclusion Criteria: For infants - no specific pathological conditions - no genetic abnormalities For mothers - history of substance abuse - mental health problems |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
University of Geneva, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain score | The PIPP-R score is a cluster of physiological and behavioural measures. Physiological assessment was calculated on the heart rate and oxygen saturation levels as collected from the patient monitor by the researcher. Inter-rater reliability was assessed by three independent coders: expert coders 1 and 2 performed blinded ratings from offline muted videos and digitally recorded physiological parameters, whereas coder 3 was a trained nurse and performed a direct online rating of the scores. Higher levels of pain scores indicate higher levels of pain | Immediately after the procedure | |
Primary | oxytocin levels | Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection. | Pre procedure | |
Primary | oxytocin levels | Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection. | Immediately after the procedure |
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