Virtual Reality Distraction for Maternal Milk Expression (PILOT)

NCT06182449 | Not Yet Recruiting

• 1 other identifier: VR-MOM-PILOT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background In neonatal intensive care units (NICUs), mothers are encouraged to express their milk using an electric breast pump. This practice is promoted by nurses and neonatologists due to its beneficial outcomes for newborns. Compared to newborns exclusively fed commercial infant formula, preterm newborns fed breast milk (BM) are less likely to suffer from necrotizing enterocolitis and late-onset sepsis. However, the discomfort associated with using an electrical pump may discourage its use, and almost all mothers start expressing their BM after a premature birth but many stop after a few weeks due to fatigue and stress. Therefore, virtual reality (VR), an immersive experience, seems to be an interesting option as it would provide a relaxing environment and distract mothers of newborns in NICU from the stress and discomfort experienced in order to promote breast milk expression. Aim The aim of this within-subject, pilot clinical trial is to assess the feasibility, acceptability, and preliminary effects of VR on stress, discomfort, and volume of expressed milk in mothers of preterm newborns. Methods Design: Within-subject, randomized pilot clinical trial in which participants are their own control. Setting and sample: Level 3 neonatal intensive care unit (NICU) at a Montreal pediatric teaching university center. Newborns under 29 weeks of age were chose to ensure that newborns would be admitted and remain in the NICU. The objective is to recruit 20 mothers of premature newborns. This will correspond to a total sample of 40 participants as they will be their own control. There will be 50% more mothers recruited (10) to compensate for the usually high attrition or rejection rate for this population, thus a total sample of 30 mothers. Healthcare professionals (nurses and doctors) providing care to participating mothers will be asked to fill a questionnaire on the feasibility of the VR intervention. Randomization and exposure to the interventions: The sequence of exposure to VR will be randomized, not the participants: sequence of 2 days with VR and 2 days without VR. The study will take place over the course of one week. Participating mothers will either be exposed to VR for a minimum of 2 sessions of 30 minutes/day for two days and the following two days to the control intervention or the opposite.

Conditions

Anxiety; Milk Expression, Breast; Breast Milk Collection

Outcome Measures

Primary Outcomes (3)

• The feasibility of VR with healthcare professionals

  Assessing the feasibility (ease of use, maintenance) of VR with nursing and medical staff. Questionnaires consisting of 10 Likert-type questions ranging from 0 to 4.

  To be reported at the end of the study participation period (1 week).

• Mothers' acceptability and satisfaction of VR

  Mothers' acceptability will be measured using the Treatment Acceptability \& Preference (TAP) questionnaire, 10 questions (6 Likert from 0 to 4 and 4 open-ended questions) as well as with the Visual Analogue Scale (VAS) from 0 (very dissatisfied) to 10 (very satisfied) for satisfaction

  Mothers' acceptability will be measured at the end of the study participation (1 week).

• Volume of milk expressed in a day

  Volume (in mL) of maternal milk expressed by the mother via a breast pump in a day. Volume will be collected by mothers in a diary provided by the NICU.

  It will be assessed every time mothers express their milk and the diary will be collected at the end of study participation (1 week).

Secondary Outcomes (5)

• Stress

  To be completed before the first sequence (On day 1) , immediately after the first sequence (On day 2), before the second sequence (On day 3) and immediately after the second sequence (On day 4) over the maximum study participation of 1 week.

• Discomfort during expression

  To be measured immediately at the end of each sequence (On day 2 and day 4) over the maximum study participation of 1 week.

• Rate of participation

  It will be reported in percentage at the end of the study time period (approximately 1 year)

• Recruitment rate

  It will be reported in percentage at the end of the study period (approx 1 year).

• Response rate to the questionnaires

  It will be reported in percentage at the end of the study period (approx 1 year).

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

Use of virtual reality (VR) during maternal milk expression.

Device: Virtual Reality Distraction

Standard Treatment

ACTIVE COMPARATOR

Mothers will express their maternal milk in a private room in the NICU with their baby or a photo of the baby.

Other: Standard Protocol

Interventions

Virtual Reality Distraction DEVICE

In a private NICU room, mothers will wear a head-mounted VR device when they will initiate the expression of their maternal milk. The video within the VR system will provide a calm forest environment with waterfalls, animals, and birdsong (INSPIRE® Program). The baby may or may not be present in the room during the intervention. This will be documented.

Virtual Reality Distraction

Standard Protocol OTHER

Mothers will express their maternal milk in a private room in the NICU with their baby or a photo of the baby. Use of any co-interventions for anxiety management (e.g. music) durign this sequence will be documented.

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• speak and read French or English
• have given birth to a premature newborn at 29 weeks or less
• minimum 18 years old
• have chosen breastfeeding
• who are at least in their second week postpartum

You may not qualify if:

• Having a mental health problem or a significant cognitive disorder that prevents them from understanding the purpose of the study
• Having a diagnosis of epilepsy

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St.Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

Location

Related Publications (23)

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MeSH Terms

Conditions

Anxiety Disorders; Breast Milk Expression

Interventions

AIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

Mental Disorders; Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Le May, PhD

CONTACT

5143454931; sylvie.lemay@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The objective is to recruit 20 mothers of premature newborns. This will correspond to a total sample of 40 participants as they will be their own control. We will recruit 50% more mothers (10) to compensate for the usually high attrition or rejection rate for this population, thus a total sample of 30 mothers. In addition, allocation to either control or intervention will be randomized at first then switched at the crossover period. However, there will be no washout period between sequences.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: December 27, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

CA (1)