Virtual Reality for Breastmilk Expression

(VR-MOM Trial)

Overseen By Sylvie Le May, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Mental health, Cognitive disorder, Epilepsy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality (VR) can ease and improve comfort for mothers expressing breast milk in the neonatal intensive care unit (NICU). Mothers with babies born at 29 weeks or earlier often find electric pumps stressful and uncomfortable. The study aims to reduce stress and discomfort and increase milk production by using VR. It compares days when VR is used during pumping with days when it is not. Eligible mothers have given birth prematurely, are at least two weeks postpartum, and have chosen to breastfeed. As an unphased trial, this study offers mothers the chance to explore innovative ways to enhance their breastfeeding experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that virtual reality is safe for use during breastmilk expression?

Research shows that using virtual reality (VR) while pumping breast milk is safe and easy to manage. Studies have found that VR headsets can reduce anxiety and discomfort for mothers of premature babies in the neonatal intensive care unit (NICU). One study reported no serious problems with VR use and noted an increase in breast milk production.

Although VR is a newer technology in maternity care, it appears to be a promising tool with few negative side effects reported. Prospective participants should discuss any concerns about joining a VR study with healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for breastmilk expression because it offers a unique form of distraction that could enhance milk production. Unlike the standard practice of expressing milk in a private room with a baby or a photo, VR immerses mothers in a different environment, potentially reducing stress and improving relaxation. This innovative approach could make the process more comfortable and efficient, possibly increasing milk volume and improving the overall experience for new mothers. By offering a novel method of engagement, VR could transform how we support breastfeeding mothers, especially in stressful settings like neonatal intensive care units (NICUs).

What evidence suggests that virtual reality is effective for promoting breast milk expression?

Research has shown that virtual reality (VR) can be a helpful tool for mothers of preterm babies in the NICU. In this trial, some participants will use VR during maternal milk expression. Studies have found that VR headsets can greatly reduce anxiety and increase breast milk production. VR likely creates a calming and distracting environment, making it more comfortable to use an electric breast pump. While researchers continue to study its effects on breastfeeding in the NICU, early results are promising. VR seems to help reduce the stress and discomfort of expressing breast milk. ^{2 5 6 7 8}

Who Is on the Research Team?

Sylvie Le May, PhD

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

This trial is for mothers with preterm newborns under 29 weeks old in a NICU at a Montreal pediatric center. They'll participate in the study for one week, using an electric breast pump to express milk. The goal is to recruit 30 mothers to account for potential dropouts.

Inclusion Criteria

Have given birth to a premature newborn at 29 weeks or less

I can speak and read either French or English.

Have chosen breastfeeding

Exclusion Criteria

I have been diagnosed with epilepsy.

I understand the purpose of the study and do not have a significant mental health or cognitive issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a randomized sequence of 2 days with VR and 2 days without VR, with a minimum of 2 sessions of 30 minutes/day for two days

1 week

Daily sessions

Follow-up

Participants are monitored for stress levels, discomfort, and volume of expressed milk

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Distraction

Trial Overview The study tests if Virtual Reality (VR) can help reduce stress and discomfort while increasing the amount of milk expressed by these mothers. Each mother will experience two days with VR distraction and two days without, serving as their own control.

How Is the Trial Designed?

Group I: Virtual Reality Distraction Experimental Treatment 1 Intervention

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

Group II: Standard Treatment Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Published Research Related to This Trial

In a study involving 59 children aged 8-17, virtual reality (VR) was found to significantly reduce fear of pain during medical procedures compared to traditional Child Life interventions and watching television.

While VR did not show a significant difference in pain intensity compared to the other methods, children reported higher satisfaction with the VR experience, suggesting it is an effective and engaging distraction tool in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Dumoulin, S., Bouchard, S., Ellis, J., et al.[2020]

A systematic review of 21 studies involving children undergoing needle procedures found that virtual reality (VR) significantly reduces both pain and fear compared to standard distraction techniques, with a notable effect size for pain reduction (P<.001).

Despite the overall low methodological quality of the studies, the findings support the effectiveness of VR as a distraction tool during painful procedures, highlighting its potential to improve the experience for children in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality on Pediatric Pain and Fear During Procedures Involving Needles: Systematic Review and Meta-analysis. Lluesma-Vidal, M., Carcelén González, R., García-Garcés, L., et al.[2022]

A randomized clinical trial involving 88 children aged 6 months to 4 years showed that using a virtual reality (VR) environment with a domed ceiling screen significantly reduced pain and distress during intravenous (IV) placement compared to standard care.

Children in the VR group had lower pain scores (median FLACC score of 6.0) compared to the control group (median FLACC score of 7.0), indicating that VR can be an effective distraction method for young patients during painful procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Virtual Reality Environment Using a Domed Ceiling Screen on Procedural Pain During Intravenous Placement in Young Children: A Randomized Clinical Trial. Lee, HN., Park, JW., Hwang, S., et al.[2023]

Over the past 20 years, there has been a notable decrease in adverse events related to sedation outside of operating rooms, highlighting improvements in patient safety during procedures.

Immersive virtual reality (VR) is emerging as an effective non-pharmacologic technique to distract patients from anxiety and pain during various medical procedures, with its application expected to grow as technology advances and costs decrease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. Hitching, R., Hoffman, HG., Garcia-Palacios, A., et al.[2023]

A study involving 42 laboring women found that immersive virtual reality (VR) significantly increased patient satisfaction during labor, with a high mean satisfaction score of 87.7 out of 100, and 95% of participants expressing a desire to use VR in future labors.

The use of VR also led to a notable reduction in pain scores during early labor, decreasing from a mean of 2.6 to 2.0 on a visual pain rating scale, indicating its potential as an effective pain relief tool in labor settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality on childbirth experience for women: a randomized controlled trial. Carus, EG., Albayrak, N., Bildirici, HM., et al.[2022]

A study involving 3,696 pediatric patients showed that virtual reality (VR) is safe for use, with very few adverse events reported, such as increased anxiety in 3.8% of cases and dizziness or nausea in less than 1%.

The use of VR significantly improved patient cooperation during medical procedures, with 99.5% of patients being cooperative after VR intervention compared to 96.7% before, indicating its efficacy in enhancing the patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. Caruso, TJ., O'Connell, C., Qian, JJ., et al.[2022]

A review of 11 controlled studies indicates that virtual reality (VR) distraction is effective in reducing both experimental pain and discomfort during burn injury care.

More advanced VR technology that fully immerses users in a virtual environment tends to provide greater pain relief, suggesting that VR could be a valuable tool for clinicians managing various pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality distraction for pain reduction: a systematic review. Malloy, KM., Milling, LS.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12224851/

The effect of virtual reality headsets on breast milk ... VR headsets may reduce anxiety (p < 0.001) and enhance breast milk production (p < 0.001) in mothers of preterm infants in the NICU.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06811298

The Effect of Breast Massage and Virtual Reality ... This randomized controlled study aims to examine the effects of breast massage and virtual reality applications on breastfeeding in women after cesarean ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39085438/

The effect of virtual reality on the breastfeeding process The aim of this study was to determine the effect of breastfeeding training given with virtual reality (VR) to postpartum mothers after cesarean section ...

4. withpower.com withpower.com/trial/phase-anxiety-2024-aa3b1

Virtual Reality for Breastmilk Expression (VR-MOM Trial) A systematic review of 21 studies involving children undergoing needle procedures found that virtual reality (VR) significantly reduces both pain and fear ...

5. link.springer.com link.springer.com/content/pdf/10.1186/s12884-025-07819-2.pdf

The effect of virtual reality headsets on breast milk ... Preliminary studies suggest VR can reduce anxiety in postpartum women [19], but its impact on breastfeeding outcomes in the NICU remains unstudied. Methods. The ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40610937/

The effect of virtual reality headsets on breast milk ... Conclusion: VR headsets may reduce anxiety (p < 0.001) and enhance breast milk production (p < 0.001) in mothers of preterm infants in the NICU.

7. sciencedirect.com sciencedirect.com/science/article/pii/S187151922300210X

Virtual Reality (VR) in the clinical maternity setting This review has identified that VR is an emerging technology in maternity that requires robust research to study potential adverse outcomes.

8. researchgate.net researchgate.net/publication/393367741_The_effect_of_virtual_reality_headsets_on_breast_milk_production_and_anxiety_in_mothers_of_preterm_infants

(PDF) The effect of virtual reality headsets on breast milk ... Breast milk volume increased significantly after VR sessions (z = 4.553, p < 0.001). A moderate negative correlation was found between anxiety and milk quantity ...