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

Sponsor

University of Geneva, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04762004

Collaborator

(none)

Enrollment

Location

Arms

27.8

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Pain, Procedural	Behavioral: Maternal speech Behavioral: Maternal singing Behavioral: Standard care	N/A

Detailed Description

Preterm birth rates are continuously increasing in almost all countries, with 15 million premature infants being born every year worldwide1. Despite rapid advances in technology, the number of preterm-born children who show short- and long-term sequelae of prematurity, even before reaching school age, remains high. Around 40% of low birth weight preterm infants experience a complex spectrum of unfavourable neurodevelopmental outcomes when compared with their pairs at term. Thus, prematurity is of great concern for health policies in both low- and high-income countries. The impaired development of preterm infants is not only associated with medical factors, but it is also at least partly a consequence of the atypical early-life environment of these infants, including exposure to pain and separation from the primary caregivers.

The aim of the present work was first, to assess whether early closeness with parents during essential but painful clinical procedures could have a positive role in pain modulation in preterm infants, thus contributing to the universal right to pain relief. Second, we aimed to investigate the possible role of the oxytocinergic system in this putative pain modulation through maternal vocal contact.

In the present protocol, we introduce the effects of separation and early pain exposure as two environmental factors that are even more deleterious when concomitant, inducing short- and long-term problems in the preterm infant's development. We then suggest that there are protective effects of early closeness between parents and preterm infants in early care and, more specifically, of early vocal contact between parents and preterm infants during hospitalisation. Lastly, we discuss the role of oxytocin (OXT) as a crucial biomarker for attachment processes and in relation to brain inflammation due to stressful procedures for preterm infants in the neonatal intensive care unit (NICU).

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Crossover clinical trial with a repeated measures design. Each patient is assigned to a sequence of three treatments (maternal speech, maternal singing, and standard treatment).Crossover clinical trial with a repeated measures design. Each patient is assigned to a sequence of three treatments (maternal speech, maternal singing, and standard treatment).

Masking:

Single (Outcomes Assessor)

Masking Description:

The pain score was assessed by two blinded independent and trained coders on muted video tracks. Oxytocin analysis were performed by an external Lab, blinded to the conditions.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 7, 2018

Actual Primary Completion Date :

May 15, 2019

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maternal speech During the intervention, mothers were asked to speak to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min.	Behavioral: Maternal speech In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.
Experimental: Maternal singing During the intervention, mothers were asked to sing to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min.	Behavioral: Maternal singing In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.
Active Comparator: Standard care During the control condition (without the mother), the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).	Behavioral: Standard care the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).

Arm

Intervention/Treatment

Experimental: Maternal speech

During the intervention, mothers were asked to speak to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min.

Behavioral: Maternal speech

In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.

Experimental: Maternal singing

During the intervention, mothers were asked to sing to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min.

Behavioral: Maternal singing

Active Comparator: Standard care

During the control condition (without the mother), the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).

Behavioral: Standard care

the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).

Outcome Measures

Primary Outcome Measures

pain score [Immediately after the procedure]
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
oxytocin levels [Pre procedure]
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.
oxytocin levels [Immediately after the procedure]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

29 Weeks to 37 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Geneva	Geneva		Switzerland	1205

Sponsors and Collaborators

University of Geneva, Switzerland

Investigators

Study Director: Didier M Grandjean, Professor, University of Geneva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manuela Filippa, Principal Investigator, University of Geneva, Switzerland

ClinicalTrials.gov Identifier:

NCT04762004

Other Study ID Numbers:

90.513

First Posted:

Feb 21, 2021

Last Update Posted:

Feb 21, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Manuela Filippa, Principal Investigator, University of Geneva, Switzerland

Oxytocin

Maternal voice

Neonatal Intensive Care Unit

Additional relevant MeSH terms:

Premature Birth

Pain, Procedural

Study Results

No Results Posted as of Feb 21, 2021