Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182449
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-08-17
Brief Title:
Virtual Reality Distraction for Maternal Milk Expression PILOT
Sponsor:
St Justines Hospital
Organization:
St Justines Hospital
Study Overview
Official Title:
Feasibility Acceptability and Effects of Virtual Reality Distraction for Management of Stress in Mothers Expressing Their Maternal Milk VR-MOM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-MOM
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 minutesday 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 minutesday 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 newborns 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 feelingsFew 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 NICUThe 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 minutesday 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 005 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 newborns 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 feelingsFew 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 NICUThe 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 minutesday 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 005 will be used but the purpose of the study is not to determine the efficacy of VR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None