Feasibility, Acceptability and Effects of Virtual Reality Distraction for Management of Stress in Mothers Expressing Their Maternal Milk (VR-MOM)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mothers' acceptability and satisfaction of VR
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Virtual Reality Distraction
Use of virtual reality (VR) during maternal milk expression.
干预措施: Virtual Reality Distraction (Device)
Standard Treatment
Mothers will express their maternal milk in a private room in the NICU with their baby or a photo of the baby.
干预措施: Standard Protocol (Other)
结局指标
主要结局
Mothers' acceptability and satisfaction of VR
时间窗: 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
The feasibility of VR with healthcare professionals
时间窗: 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.
Volume of milk expressed in a day
时间窗: 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.
次要结局
- Discomfort during expression(To be measured immediately at the end of each sequence (On day 2 and day 4) over the maximum study participation of 1 week.)
- Response rate to the questionnaires(It will be reported in percentage at the end of the study period (approx 1 year).)
- Stress(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.)
- Rate of participation(It will be reported in percentage at the end of the study time period (approximately 1 year))
- Recruitment rate(It will be reported in percentage at the end of the study period (approx 1 year).)
研究者
Sylvie Le May
Principal Investigator
St. Justine's Hospital
