Virtual Reality Distraction for Maternal Milk Expression (PILOT)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSt. Justine's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Virtual Reality Distraction
DeviceIn 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 Protocol
Other interventionMothers 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality DistractionExperimental treatment 1 intervention
Group B: Standard TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
To be reported at the end of the study participation period (1 week).2
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
Time frame
Mothers' acceptability will be measured at the end of the study participation (1 week).3
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.
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).Secondary outcomes
1
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.
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.2
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
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.3
Rate of participation
Rate of participants completing all the measures at the end of the study.
Time frame
It will be reported in percentage at the end of the study time period (approximately 1 year)4
Recruitment rate
Rate in percentage of participants recruited for the study
Time frame
It will be reported in percentage at the end of the study period (approx 1 year).Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: