NCT04762004

Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures

Completed NA Last updated 21 February 2021

What this trial tests

NA trial testing Maternal speech in Preterm Birth in 20 participants. Completed in 1 July 2020.

Timeline

7 March 2018

Primary endpoint
15 May 2019

1 July 2020

Quick facts

Lead sponsor	University of Geneva, Switzerland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	supportive care
Enrollment	20
Start date	7 March 2018
Primary completion	15 May 2019
Estimated completion	1 July 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• Maternal speech
• Maternal singing
• Standard care — full drug profile →

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →
• Pain, Procedural — all drugs for Pain, Procedural →

Sponsor

University of Geneva, Switzerland

Who can join

Adults 29 Weeks to 37 Weeks, any sex, with Preterm Birth or Pain, Procedural. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.