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

NCT04762004 | Completed DMC

• 1 other identifier: 90.513
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Pain, Procedural

Keywords

Oxytocin; Maternal voice; Neonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Maternal speech

EXPERIMENTAL

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

Maternal singing

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

Maternal speech BEHAVIORAL

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.

Maternal speech

Maternal singing BEHAVIORAL

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.

Maternal singing

Standard care BEHAVIORAL

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).

Standard care

Eligibility Criteria

• Age: 29 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age \>29 weeks gestational age at birth,
• weight \>1000 g
• stable medical condition (absence of mechanical ventilation, no additional oxygen)

You may not qualify if:

• For infants
• no specific pathological conditions
• no genetic abnormalities
• For mothers
• history of substance abuse
• mental health problems

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

University of Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Premature Birth; Pain, Procedural

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Didier M Grandjean, Professor

  University of Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 21, 2021
• Study Start: March 7, 2018
• Primary Completion: May 15, 2019
• Study Completion: July 1, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)