Virtual Reality Distraction for Maternal Milk Expression (PILOT)
NCT ID: NCT06182449
Last Updated: 2025-08-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-31
Study Completion Date
2027-06-30
Brief Summary
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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.
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.
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Detailed Description
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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
1. The primary research objectives are to determine:
2. The feasibility (ease of use, maintenance) of VR with nursing and medical staff
3. The mothers' acceptability and satisfaction of VR
4. The preliminary effects of VR on the volume of breast milk expressed by participating mothers.
The secondary objectives of this study are as follows:
1. To evaluate the preliminary effects of VR on stress levels and discomfort among participating mothers
2. 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
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
1. The primary research objectives are to determine:
2. The feasibility (ease of use, maintenance) of VR with nursing and medical staff
3. The mothers' acceptability and satisfaction of VR
4. The preliminary effects of VR on the volume of breast milk expressed by participating mothers.
The secondary objectives of this study are as follows:
1. To evaluate the preliminary effects of VR on stress levels and discomfort among participating mothers
2. 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
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Anxiety
Milk Expression, Breast
Breast Milk Collection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
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.
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Virtual Reality Distraction
Use of virtual reality (VR) during maternal milk expression.
Group Type
EXPERIMENTAL
Virtual Reality Distraction
Intervention Type
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.
Standard Treatment
Mothers will express their maternal milk in a private room in the NICU with their baby or a photo of the baby.
Group Type
ACTIVE_COMPARATOR
Standard Protocol
Intervention Type
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.
Interventions
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Virtual Reality Distraction
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.
Intervention Type
DEVICE
Standard Protocol
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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. speak and read French or English
2. have given birth to a premature newborn at 29 weeks or less
3. minimum 18 years old
4. have chosen breastfeeding
5. who are at least in their second week postpartum
2. have given birth to a premature newborn at 29 weeks or less
3. minimum 18 years old
4. have chosen breastfeeding
5. who are at least in their second week postpartum
Exclusion Criteria
1. Having a mental health problem or a significant cognitive disorder that prevents them from understanding the purpose of the study
2. Having a diagnosis of epilepsy
2. Having a diagnosis of epilepsy
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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St. Justine's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Sylvie Le May
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Sylvie Le May, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Justine's Hospital
Locations
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St.Justine's Hospital
Montreal, Quebec, Canada
Site Status
Countries
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Canada
Central Contacts
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References
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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.
Reference Type
BACKGROUND
Schanler 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.
Reference Type
BACKGROUND
Dieterich 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.
Reference Type
BACKGROUND
Vohr 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.
Reference Type
BACKGROUND
Vohr 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.
Reference Type
BACKGROUND
Isaacs 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.
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BACKGROUND
Infant 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/
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BACKGROUND
Keith 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.
Reference Type
BACKGROUND
Juncker 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.
Reference Type
BACKGROUND
Tekgunduz 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.
Reference Type
BACKGROUND
Hill 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.
Reference Type
BACKGROUND
Morey 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.
Reference Type
BACKGROUND
Shaw 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.
Reference Type
BACKGROUND
Foligno 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.
Reference Type
BACKGROUND
Lebel 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.
Reference Type
BACKGROUND
Acuna-Muga J, Ureta-Velasco N, de la Cruz-Bertolo J, Ballesteros-Lopez R, Sanchez-Martinez R, Miranda-Casabona E, Miguel-Trigoso A, Garcia-San Jose L, Pallas-Alonso C. Volume of milk obtained in relation to location and circumstances of expression in mothers of very low birth weight infants. J Hum Lact. 2014 Feb;30(1):41-6. doi: 10.1177/0890334413509140. Epub 2013 Nov 8.
Reference Type
BACKGROUND
Hurst N, Engebretson J, Mahoney JS. Providing mother's own milk in the context of the NICU: a paradoxical experience. J Hum Lact. 2013 Aug;29(3):366-73. doi: 10.1177/0890334413485640. Epub 2013 May 1.
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BACKGROUND
Dagli E, Celik N. The effect of oxytocin massage and music on breast milk production and anxiety level of the mothers of premature infants who are in the neonatal intensive care unit: A self-controlled trial. Health Care Women Int. 2022 May;43(5):465-478. doi: 10.1080/07399332.2021.1947286. Epub 2021 Jul 20.
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BACKGROUND
Ak J, Lakshmanagowda PB, G C M P, Goturu J. Impact of music therapy on breast milk secretion in mothers of premature newborns. J Clin Diagn Res. 2015 Apr;9(4):CC04-6. doi: 10.7860/JCDR/2015/11642.5776. Epub 2015 Apr 1.
Reference Type
BACKGROUND
Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
Reference Type
BACKGROUND
Feher SD, Berger LR, Johnson JD, Wilde JB. Increasing breast milk production for premature infants with a relaxation/imagery audiotape. Pediatrics. 1989 Jan;83(1):57-60.
Reference Type
BACKGROUND
Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
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Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.
Reference Type
BACKGROUND
Other Identifiers
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VR-MOM-PILOT
Identifier Type: -
Identifier Source: org_study_id
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