AnxietyVR-MOMNCT06182449
Virtual Reality Distraction for Maternal Milk Expression (PILOT)
A study testing Virtual Reality Distraction and Standard Protocol in people with Anxiety and Milk Expression, Breast, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Milk Expression, Breast, Breast Milk Collection
- What is being tested?
- Virtual Reality Distraction and Standard Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility, Acceptability and Effects of Virtual Reality Distraction for Management of Stress in Mothers Expressing Their Maternal Milk (VR-MOM)
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
Read more
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.
Read the detailed description
In neonatal intensive care units (NICUs), mothers are encouraged to express their milk using an electric breast pump. The milk is then fed to the premature newborns by a feeding tube until they are stable and mature enough to feed at the breast or by bottle. 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. In addition, preterm births are often associated with multiple stressors (C-section, separation from the newborn). However, the discomfort associated with using an electrical pump may discourage its use (noise, uncomfortable sensations in the breasts). Overall, almost all mothers start expressing their BM after a premature birth but many stop after a few weeks due to fatigue and stress.
Current recommendations for mothers expressing BM in the NICU include regular skin-to-skin contact as well as being at the bedside or looking at the newborn's photo. Although these methods are effective in increasing BM production, they are not used by all mothers in the NICU. It appears that these strategies remind mothers of being separated from their newborn. Using distraction strategies when expressing BM could be a coping mechanism for such feelings.Few distraction interventions aimed at reducing maternal stress during breast milk expression have been identified in the literature. Some studies have examined the effect of music during milk expression in mothers of newborns hospitalized in the NICU. Researchers observed BM volume increase, nutritional value improvement and maternal cortisol level decrease. Furthermore, interventions focused on relaxation techniques for breastfeeding mothers have shown an increase in milk volume and a weight gain in newborns. Therefore, virtual reality (VR), an immersive experience (auditory and visually) 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.
Objectives
- The primary research objectives are to determine:
- The feasibility (ease of use, maintenance) of VR with nursing and medical staff
- The mothers' acceptability and satisfaction of VR
- The preliminary effects of VR on the volume of breast milk expressed by participating mothers.
The secondary objectives of this study are as follows:
- To evaluate the preliminary effects of VR on stress levels and discomfort among participating mothers
- The feasibility of the within-subject clinical trial design (participation, recruitment rate, and questionnaires' response rates, ease of the data collection process, etc.)
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 chosen to ensure that they 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 (10) recruited 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 in the same week. 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. The frequency of VR use will be documented.
Measures of the primary outcomes
Measures of the feasibility of the VR intervention and the design (healthcare professionals related to participants) : Questionnaires consisting of 10 Likert-type questions ranging from 0 (= strongly disagree) to 4 (= strongly agree), to be completed at the end of the study participation period.
Measures of acceptability and satisfaction with the VR intervention (mothers): Mothers' acceptability will be measured using the Treatment Acceptability \& Preference (TAP) questionnaire, 10 questions (6 Likert from 0 (= not at all) to 4 (= strongly) and 4 open-ended questions) as well as with the VAS from 0 (= completely unsatisfied) to 10 (= extremely satisfied) for satisfaction.
Volume of milk expressed: Volume (in mL) of maternal milk expressed by the mother via a breast pump after each milk expression session. Volume will be collected by mothers in a diary provided by the NICU.
Virtual reality specifications
Virtual reality (VR) immerses patients both visually and auditorily in an artificial environment. Inside the virtual reality headset, a depiction of a scene or an imaginary place can be visualized. The INSPIRE Therapeutic Virtual Reality program combines elements of relaxation and sensor-guided deep breathing exercises. The user is immersed in a peaceful forest. In order to lift a feather, the participant has to control her breathing and follow the rhythm suggested. The headset and the relaxation program were designed by Paperplane Therapeutics.
Analyses
Means, standard deviations, and confidence intervals for quantitative data. Paired t-tests to compare the results of the two groups (expressed volume and discomfort). Comparisons of stress at the 4 measurement times using Repeated Measures-ANOVAs (intra- and intersubject comparisons, controlling for carry-over effect). Subgroup analyses (gender, breastfeeding experience, gestational age, number of VR sessions) are planned. A significance level of 0.05 will be used, but the purpose of the study is not to determine the efficacy of VR
- Conditions
- Anxiety, Milk Expression, Breast, Breast Milk Collection
- Being tested
- Virtual Reality Distraction, Standard Protocol
- Medical subject headings
- Anxiety Disorders, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionDevice
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.
Standard ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Distraction | Experimental | Use of virtual reality (VR) during maternal milk expression. Receives: 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. Receives: Other: Standard Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Level of stress of mothers will be measured at the beginning and end of each two-days-long sequence with a Visual Analogue Scale (VAS) from 0 to 10, and one of the subscales (Relationships with baby and parental role) of the Parental Stressor Scale-Neonatal Intensive Care Unit (PSS-NICU), 11 Likert-type questions, from 1 to 5.
Measured: 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
Level of mothers' discomfort measured at the end of each two-days-long sequence, with a Visual Analogue Scale (VAS) from 0 to 10
Measured: 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
Rate of participants completing all the measures at the end of the study.
Measured: It will be reported in percentage at the end of the study time period (approximately 1 year)
Recruitment rate
Rate in percentage of participants recruited for the study
Measured: It will be reported in percentage at the end of the study period (approx 1 year).
Response rate to the questionnaires
Rate in percentage of completed questionnaires
Measured: It will be reported in percentage at the end of the study period (approx 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Le May, St. Justine's Hospital
- Investigators
- Sylvie Le May, PhD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182449
- Sponsor's protocol ID
- VR-MOM-PILOT
- Acronym
- VR-MOM
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mizuno K, Ueda A. The maturation and coordination of sucking, swallowing, and respiration in preterm infants. J Pediatr. 2003 Jan;142(1):36-40. doi: 10.1067/mpd.2003.mpd0312.
PubMed 12520252Schanler RJ, Shulman RJ, Lau C. Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk versus preterm formula. Pediatrics. 1999 Jun;103(6 Pt 1):1150-7. doi: 10.1542/peds.103.6.1150.
PubMed 10353922Dieterich CM, Felice JP, O'Sullivan E, Rasmussen KM. Breastfeeding and health outcomes for the mother-infant dyad. Pediatr Clin North Am. 2013 Feb;60(1):31-48. doi: 10.1016/j.pcl.2012.09.010. Epub 2012 Nov 3.
PubMed 23178059Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Wright LL, Langer JC, Poole WK; NICHD Neonatal Research Network. Beneficial effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age. Pediatrics. 2006 Jul;118(1):e115-23. doi: 10.1542/peds.2005-2382.
PubMed 16818526Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Higgins RD, Langer JC, Poole WK; National Institute of Child Health and Human Development National Research Network. Persistent beneficial effects of breast milk ingested in the neonatal intensive care unit on outcomes of extremely low birth weight infants at 30 months of age. Pediatrics. 2007 Oct;120(4):e953-9. doi: 10.1542/peds.2006-3227.
PubMed 17908750Isaacs EB, Fischl BR, Quinn BT, Chong WK, Gadian DG, Lucas A. Impact of breast milk on intelligence quotient, brain size, and white matter development. Pediatr Res. 2010 Apr;67(4):357-62. doi: 10.1203/PDR.0b013e3181d026da.
PubMed 20035247Infant and Young Child Feeding: Model Chapter for Textbooks for Medical Students and Allied Health Professionals. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK148965/
PubMed 23905206Keith DR, Weaver BS, Vogel RL. The effect of music-based listening interventions on the volume, fat content, and caloric content of breast milk-produced by mothers of premature and critically ill infants. Adv Neonatal Care. 2012 Apr;12(2):112-9. doi: 10.1097/ANC.0b013e31824d9842.
PubMed 22469966Juncker HG, Naninck EFG, Schipper L, Lucassen PJ, van Goudoever JB, de Rooij SR, Korosi A. Maternal stress in the postpartum period is associated with altered human milk fatty acid composition. Clin Nutr. 2022 Nov;41(11):2517-2528. doi: 10.1016/j.clnu.2022.09.013. Epub 2022 Sep 28.
PubMed 36223713Tekgunduz SE, Lazoglu M, Nailoglu M, Apay SE, Tekgunduz KS. The Relationship of Preterm, Term, and Post-Term Births to Maternal Stress and Human Milk Cortisol Levels. Breastfeed Med. 2023 Jun;18(6):462-468. doi: 10.1089/bfm.2023.0006.
PubMed 37335326Hill PD, Aldag JC, Chatterton RT, Zinaman M. Comparison of milk output between mothers of preterm and term infants: the first 6 weeks after birth. J Hum Lact. 2005 Feb;21(1):22-30. doi: 10.1177/0890334404272407.
PubMed 15681632Morey JA, Gregory K. Nurse-led education mitigates maternal stress and enhances knowledge in the NICU. MCN Am J Matern Child Nurs. 2012 May-Jun;37(3):182-91. doi: 10.1097/NMC.0b013e31824b4549.
PubMed 22549422Shaw RJ, Bernard RS, Deblois T, Ikuta LM, Ginzburg K, Koopman C. The relationship between acute stress disorder and posttraumatic stress disorder in the neonatal intensive care unit. Psychosomatics. 2009 Mar-Apr;50(2):131-7. doi: 10.1176/appi.psy.50.2.131.
PubMed 19377021Foligno S, Finocchi A, Brindisi G, Pace A, Amadio P, Dall'Oglio I, Portanova A, Rossi P, Dotta A, Salvatori G. Evaluation of Mother's Stress during Hospitalization Can Influence the Breastfeeding Rate. Experience in Intensive and Non Intensive Departments. Int J Environ Res Public Health. 2020 Feb 18;17(4):1298. doi: 10.3390/ijerph17041298.
PubMed 32085465Lebel V, Feeley N, Robins S, Stremler R. Factors Influencing Mothers' Quality of Sleep during Their Infants' NICU Hospitalization. Behav Sleep Med. 2022 Sep-Oct;20(5):610-621. doi: 10.1080/15402002.2021.1971985. Epub 2021 Sep 2.
PubMed 34472406
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Effects of Virtual Reality Distraction for Management of Stress in Mothers Expressing Their Maternal Milk (VR-MOM)
- ClinicalTrials.gov ID
- NCT06182449
- Acronym / sponsor ID
- VR-MOM / VR-MOM-PILOT
- Conditions
- Anxiety, Milk Expression, Breast, Breast Milk Collection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In neonatal intensive care units (NICUs), mothers are encouraged to express their milk using an electric breast pump. The milk is then fed to the premature newborns by a feeding tube until they are stable and mature enough to feed at the breast or by bottle. 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. In addition, preterm births are often associated with multiple stressors (C-section, separation from the newborn). However, the discomfort associated with using an electrical pump may discourage its use (noise, uncomfortable sensations in the breasts). Overall, almost all mothers start expressing their BM after a premature birth but many stop after a few weeks due to fatigue and stress.
Current recommendations for mothers expressing BM in the NICU include regular skin-to-skin contact as well as being at the bedside or looking at the newborn's photo. Although these methods are effective in increasing BM production, they are not used by all mothers in the NICU. It appears that these strategies remind mothers of being separated from their newborn. Using distraction strategies when expressing BM could be a coping mechanism for such feelings.Few distraction interventions aimed at reducing maternal stress during breast milk expression have been identified in the literature. Some studies have examined the effect of music during milk expression in mothers of newborns hospitalized in the NICU. Researchers observed BM volume increase, nutritional value improvement and maternal cortisol level decrease. Furthermore, interventions focused on relaxation techniques for breastfeeding mothers have shown an increase in milk volume and a weight gain in newborns. Therefore, virtual reality (VR), an immersive experience (auditory and visually) 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.
Objectives
- The primary research objectives are to determine:
- The feasibility (ease of use, maintenance) of VR with nursing and medical staff
- The mothers' acceptability and satisfaction of VR
- The preliminary effects of VR on the volume of breast milk expressed by participating mothers.
The secondary objectives of this study are as follows:
- To evaluate the preliminary effects of VR on stress levels and discomfort among participating mothers
- The feasibility of the within-subject clinical trial design (participation, recruitment rate, and questionnaires' response rates, ease of the data collection process, etc.)
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 chosen to ensure that they 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 (10) recruited 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 in the same week. 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. The frequency of VR use will be documented.
Measures of the primary outcomes
Measures of the feasibility of the VR intervention and the design (healthcare professionals related to participants) : Questionnaires consisting of 10 Likert-type questions ranging from 0 (= strongly disagree) to 4 (= strongly agree), to be completed at the end of the study participation period.
Measures of acceptability and satisfaction with the VR intervention (mothers): Mothers' acceptability will be measured using the Treatment Acceptability \& Preference (TAP) questionnaire, 10 questions (6 Likert from 0 (= not at all) to 4 (= strongly) and 4 open-ended questions) as well as with the VAS from 0 (= completely unsatisfied) to 10 (= extremely satisfied) for satisfaction.
Volume of milk expressed: Volume (in mL) of maternal milk expressed by the mother via a breast pump after each milk expression session. Volume will be collected by mothers in a diary provided by the NICU.
Virtual reality specifications
Virtual reality (VR) immerses patients both visually and auditorily in an artificial environment. Inside the virtual reality headset, a depiction of a scene or an imaginary place can be visualized. The INSPIRE Therapeutic Virtual Reality program combines elements of relaxation and sensor-guided deep breathing exercises. The user is immersed in a peaceful forest. In order to lift a feather, the participant has to control her breathing and follow the rhythm suggested. The headset and the relaxation program were designed by Paperplane Therapeutics.
Analyses
Means, standard deviations, and confidence intervals for quantitative data. Paired t-tests to compare the results of the two groups (expressed volume and discomfort). Comparisons of stress at the 4 measurement times using Repeated Measures-ANOVAs (intra- and intersubject comparisons, controlling for carry-over effect). Subgroup analyses (gender, breastfeeding experience, gestational age, number of VR sessions) are planned. A significance level of 0.05 will be used, but the purpose of the study is not to determine the efficacy of VR
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Distraction | Experimental | Device: Virtual Reality DistractionUse of virtual reality (VR) during maternal milk expression. |
| Standard Treatment | Active comparator | Other: Standard ProtocolMothers will express their maternal milk in a private room in the NICU with their baby or a photo of the baby. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality DistractionIn 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. | Device | Virtual Reality Distraction |
| Standard ProtocolMothers 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. | Other | Standard Treatment |
Primary outcome
The feasibility of VR with healthcare professionals
Time frame: To be reported at the end of the study participation period (1 week).
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.
Mothers' acceptability and satisfaction of VR
Time frame: Mothers' acceptability will be measured at the end of the study participation (1 week).
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
Volume of milk expressed in a day
Time frame: It will be assessed every time mothers express their milk and the diary will be collected at the end of study participation (1 week).
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.
5 secondary outcomes
Stress
Time frame: 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
Time frame: 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
Time frame: It will be reported in percentage at the end of the study time period (approximately 1 year)
Recruitment rate
Time frame: It will be reported in percentage at the end of the study period (approx 1 year).
Response rate to the questionnaires
Time frame: It will be reported in percentage at the end of the study period (approx 1 year).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 12520252Mizuno K, Ueda A. The maturation and coordination of sucking, swallowing, and respiration in preterm infants. J Pediatr. 2003 Jan;142(1):36-40. doi: 10.1067/mpd.2003.mpd0312.
- Background: PubMed 10353922Schanler RJ, Shulman RJ, Lau C. Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk versus preterm formula. Pediatrics. 1999 Jun;103(6 Pt 1):1150-7. doi: 10.1542/peds.103.6.1150.
- Background: PubMed 23178059Dieterich CM, Felice JP, O'Sullivan E, Rasmussen KM. Breastfeeding and health outcomes for the mother-infant dyad. Pediatr Clin North Am. 2013 Feb;60(1):31-48. doi: 10.1016/j.pcl.2012.09.010. Epub 2012 Nov 3.
- Background: PubMed 16818526Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Wright LL, Langer JC, Poole WK; NICHD Neonatal Research Network. Beneficial effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age. Pediatrics. 2006 Jul;118(1):e115-23. doi: 10.1542/peds.2005-2382.
- Background: PubMed 17908750Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Higgins RD, Langer JC, Poole WK; National Institute of Child Health and Human Development National Research Network. Persistent beneficial effects of breast milk ingested in the neonatal intensive care unit on outcomes of extremely low birth weight infants at 30 months of age. Pediatrics. 2007 Oct;120(4):e953-9. doi: 10.1542/peds.2006-3227.
- Background: PubMed 20035247Isaacs EB, Fischl BR, Quinn BT, Chong WK, Gadian DG, Lucas A. Impact of breast milk on intelligence quotient, brain size, and white matter development. Pediatr Res. 2010 Apr;67(4):357-62. doi: 10.1203/PDR.0b013e3181d026da.
- Background: PubMed 23905206Infant and Young Child Feeding: Model Chapter for Textbooks for Medical Students and Allied Health Professionals. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK148965/
- Background: PubMed 22469966Keith DR, Weaver BS, Vogel RL. The effect of music-based listening interventions on the volume, fat content, and caloric content of breast milk-produced by mothers of premature and critically ill infants. Adv Neonatal Care. 2012 Apr;12(2):112-9. doi: 10.1097/ANC.0b013e31824d9842.
- Background: PubMed 36223713Juncker HG, Naninck EFG, Schipper L, Lucassen PJ, van Goudoever JB, de Rooij SR, Korosi A. Maternal stress in the postpartum period is associated with altered human milk fatty acid composition. Clin Nutr. 2022 Nov;41(11):2517-2528. doi: 10.1016/j.clnu.2022.09.013. Epub 2022 Sep 28.
- Background: PubMed 37335326Tekgunduz SE, Lazoglu M, Nailoglu M, Apay SE, Tekgunduz KS. The Relationship of Preterm, Term, and Post-Term Births to Maternal Stress and Human Milk Cortisol Levels. Breastfeed Med. 2023 Jun;18(6):462-468. doi: 10.1089/bfm.2023.0006.
- Background: PubMed 15681632Hill PD, Aldag JC, Chatterton RT, Zinaman M. Comparison of milk output between mothers of preterm and term infants: the first 6 weeks after birth. J Hum Lact. 2005 Feb;21(1):22-30. doi: 10.1177/0890334404272407.
- Background: PubMed 22549422Morey JA, Gregory K. Nurse-led education mitigates maternal stress and enhances knowledge in the NICU. MCN Am J Matern Child Nurs. 2012 May-Jun;37(3):182-91. doi: 10.1097/NMC.0b013e31824b4549.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvie Le May, PhD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Distraction and Standard Protocol in people with Anxiety and Milk Expression, Breast, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Le May, PhD (5143454931 ext. 4938, sylvie.lemay@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of VR with healthcare professionals (time frame: To be reported at the end of the study participation period (1 week).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182449, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.