Clinical trial NCT06182449: Virtual Reality Distraction for Maternal Milk Expression (PILOT)
Official title: Feasibility, Acceptability and Effects of Virtual Reality Distraction for Management of Stress in Mothers Expressing Their Maternal Milk (VR-MOM)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Milk Expression, Breast
Breast Milk Collection
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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

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

Eligibility criteria: 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

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

Primary outcomes:
measure: The feasibility of VR with healthcare professionals
timeFrame: To be reported at the end of the study participation period (1 week).
measure: Mothers' acceptability and satisfaction of VR
timeFrame: Mothers' acceptability will be measured at the end of the study participation (1 week).
measure: Volume of milk expressed in a day
timeFrame: 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:
measure: Stress
timeFrame: 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.
measure: Discomfort during expression
timeFrame: To be measured immediately at the end of each sequence (On day 2 and day 4) over the maximum study participation of 1 week.
measure: Rate of participation
timeFrame: It will be reported in percentage at the end of the study time period (approximately 1 year)
measure: Recruitment rate
timeFrame: It will be reported in percentage at the end of the study period (approx 1 year).
measure: Response rate to the questionnaires
timeFrame: It will be reported in percentage at the end of the study period (approx 1 year).
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: St.Justine's Hospital
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Sylvie Le May, PhD
role: PRINCIPAL_INVESTIGATOR
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