Virtual Reality in Obstetric Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Women's Studies |
| Therapuetic Areas: | Musculoskeletal, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/25/2018 |
| Start Date: | July 3, 2018 |
| End Date: | May 2020 |
| Contact: | Ahtziri Fonseca |
| Email: | aef22011@stanford.edu |
| Phone: | 650 4970927 |
Virtual Reality Obstetrics Phase 1 & Phase 2 Prospective Study
The purpose of this study is to determine if non-invasive distracting devices (Virtual
Reality headset) are more effective than the standard of care (i.e., no technology based
distraction) for preventing anxiety and pain scores in women who are undergoing child
laboring procedures. The anticipated primary outcome will be a reduction of pregnant females
overall anxiety and pain scores before and after such procedure(s), including but not limited
to epidural/combined spinal epidural (CSE), IV placement and/or labor.
Reality headset) are more effective than the standard of care (i.e., no technology based
distraction) for preventing anxiety and pain scores in women who are undergoing child
laboring procedures. The anticipated primary outcome will be a reduction of pregnant females
overall anxiety and pain scores before and after such procedure(s), including but not limited
to epidural/combined spinal epidural (CSE), IV placement and/or labor.
Phase 1 There will be 3 stages that are sequentially and chronologically timed in order to
asses the efficacy of Virtual Reality (VR) in the reducing epidural/combined spinal-epidural
(CSE) related pain and anxiety at every stage. Phase 1 is the development phase where the
focus is primarily on feasibility for Phase 2. The exclusion criteria will remain the same
for all the stages and includes (i) participants and patients who do not consent (ii) have
significant cognitive impairment (iii) have a history of severe motion sickness (iv)
currently have nausea (v) currently experiencing seizures (vi) have visual problems(vii) are
clinically unstable or require urgent/emergent intervention and/or (viii) are Non-English
Speaking. Inclusion criteria is that females are (i)18 years or older and (ii) who had either
have a history of, planning to have, or currently having an child laboring related procedures
such as IV placement, epidural/CSE placement and/or labor.
(Stage 1) The first stage will include 10 females who are not pregnant, but have previously
have at least undergone one labor epidural/CSE in the past. These mothers will be approached
by a clinician or healthcare provider at Lucille Packard Children's Hospital (LPCH)
outpatient surgical procedures as they wait for their child. If they are interested, the
healthcare provider will let the research staff know of the eligible participant. During the
mother's wait time, the research assistant will review the study, go over the consent forms
and answer any questions in regards to their participation in the study. Once the participant
is consented into the study, the research assistant will provide the participant with a
survey regarding their recall pain and anxiety (refer to section 16) during their most recent
epidural (if participant has had previously had more than one). The research assistant will
then provide the participant with a VR headset and guide them through a series of VR scenery,
shortly after the VR simulation the participant will be given a feedback survey in regards to
their VR experience.
(Stage 2) The second stage will include 10 different females who are currently either in
their second or third trimester of pregnancy. These mothers will be approached by a clinician
or healthcare provider during their visits to obstetrics clinic at LPCH and Stanford Health
Care (SHC) facilities. If they are interested, the healthcare provider will let the research
staff know of the eligible participant. During the patients wait time, the research assistant
will review the study, go over the consent forms and answer any questions in regards to their
participation in the study. Once the participant is consented into the study, the research
assistant will provide the participant with a survey regarding their current anxiety about
labor and epidural/CSE placement. The research assistant will then provide the participant
with a VR headset and guide them through a series of VR scenery, shortly after the VR
simulation the participant will be given a feedback survey in regards to their VR experience.
Since this cohort can give the investigators better guidance of intolerance (i.e nausea and
dizziness) during VR simulation, the clinicians and research providers have come up with a
safety threshold: if more than 20 percent of patients answer to a score of 4 or higher on
questions regarding nausea and dizziness, the clinicians and health care providers will have
to go back and iterate on VR software and repeat the previous stage before moving on stage 3.
(Stage 3) If stage 2 outcomes meet the investigator's criteria, the clinical team will move
on to the last stage of 10 different females who are currently in labor and planning on
undergoing an epidural for child-laboring. These mothers will be approached by their
obstetric anesthesiologist during their first anesthesia consult after being admitted into
LPCH labor and delivery facilities. If they are interested, the anesthesiologist will let the
research staff know of the eligible participant. During the patients wait time, the research
assistant and/or anesthesiologist will review the study, go over the consent forms and answer
any questions in regards to their participation in the study. Once the patient is consented
into the study, the research assistant and/or anesthesiologist will provide the participant
with a survey regarding their pre-epidural anxiety and pain scores. The anesthesiologist
and/or research assistant will then provide the laboring mother with a VR headset during
epidural/CSE placement by anesthesiologist. Depending on the mother's laboring timeline, if
possible, mother will receive VR feedback survey and post-epidural anxiety and pain scores.
If not, mothers will receive post-epidural anxiety and pain scores where they recall these
scores and fill out VR feedback survey postpartum.
Phase 2:
Based on preliminary and feasibility data from Phase 1, if the clinicians and study personnel
find it appropriate, the study will move on to Phase 2, a randomized prospective clinical
trial focused more broadly on technology based distractions (VR headsets) in comparison to
standard of care (no VR use) in obstetric patients for preventing anxiety and pain during
various laboring procedures. These laboring procedures include but are not limited to IV,
epidural/CSE placement and/or child-labor. Inclusion and exclusion criteria will remain the
same as Phase 1. For Phase 2, the study personnel expect to enroll 200 mothers who've been
admitted into LPCH labor and delivery services. These mothers will be approached by their
obstetric anesthesiologist during their first anesthesia consult after being admitted into
LPCH labor and delivery facilities. If they are interested, the anesthesiologist will let the
research staff know of the eligible participant. During the patients wait time, the research
assistant and/or anesthesiologist will review the study, go over the consent forms and answer
any questions in regards to their participation in the study. Once the patient is consented
into the study, the research assistant and/or anesthesiologist will provide the participant
with a survey regarding their pre-procedure anxiety and pain scores. Depending on a
randomized generator, mothers will either be placed into VR use group during procedure or
standard of care (no VR use). If mother falls under VR group, the anesthesiologist and/or
research assistant will then provide the laboring mother with a VR headset during procedure
by anesthesiologist. Depending on the mother's laboring timeline, if possible, mother will
receive VR feedback survey and post- procedure anxiety and pain scores. If not, mothers will
receive post-epidural anxiety and pain scores where they recall these scores and fill out VR
feedback survey postpartum. If mother falls under control group, mother will undergo standard
of care and receive pre and post- pain and anxiety surveys regarding procedure.
asses the efficacy of Virtual Reality (VR) in the reducing epidural/combined spinal-epidural
(CSE) related pain and anxiety at every stage. Phase 1 is the development phase where the
focus is primarily on feasibility for Phase 2. The exclusion criteria will remain the same
for all the stages and includes (i) participants and patients who do not consent (ii) have
significant cognitive impairment (iii) have a history of severe motion sickness (iv)
currently have nausea (v) currently experiencing seizures (vi) have visual problems(vii) are
clinically unstable or require urgent/emergent intervention and/or (viii) are Non-English
Speaking. Inclusion criteria is that females are (i)18 years or older and (ii) who had either
have a history of, planning to have, or currently having an child laboring related procedures
such as IV placement, epidural/CSE placement and/or labor.
(Stage 1) The first stage will include 10 females who are not pregnant, but have previously
have at least undergone one labor epidural/CSE in the past. These mothers will be approached
by a clinician or healthcare provider at Lucille Packard Children's Hospital (LPCH)
outpatient surgical procedures as they wait for their child. If they are interested, the
healthcare provider will let the research staff know of the eligible participant. During the
mother's wait time, the research assistant will review the study, go over the consent forms
and answer any questions in regards to their participation in the study. Once the participant
is consented into the study, the research assistant will provide the participant with a
survey regarding their recall pain and anxiety (refer to section 16) during their most recent
epidural (if participant has had previously had more than one). The research assistant will
then provide the participant with a VR headset and guide them through a series of VR scenery,
shortly after the VR simulation the participant will be given a feedback survey in regards to
their VR experience.
(Stage 2) The second stage will include 10 different females who are currently either in
their second or third trimester of pregnancy. These mothers will be approached by a clinician
or healthcare provider during their visits to obstetrics clinic at LPCH and Stanford Health
Care (SHC) facilities. If they are interested, the healthcare provider will let the research
staff know of the eligible participant. During the patients wait time, the research assistant
will review the study, go over the consent forms and answer any questions in regards to their
participation in the study. Once the participant is consented into the study, the research
assistant will provide the participant with a survey regarding their current anxiety about
labor and epidural/CSE placement. The research assistant will then provide the participant
with a VR headset and guide them through a series of VR scenery, shortly after the VR
simulation the participant will be given a feedback survey in regards to their VR experience.
Since this cohort can give the investigators better guidance of intolerance (i.e nausea and
dizziness) during VR simulation, the clinicians and research providers have come up with a
safety threshold: if more than 20 percent of patients answer to a score of 4 or higher on
questions regarding nausea and dizziness, the clinicians and health care providers will have
to go back and iterate on VR software and repeat the previous stage before moving on stage 3.
(Stage 3) If stage 2 outcomes meet the investigator's criteria, the clinical team will move
on to the last stage of 10 different females who are currently in labor and planning on
undergoing an epidural for child-laboring. These mothers will be approached by their
obstetric anesthesiologist during their first anesthesia consult after being admitted into
LPCH labor and delivery facilities. If they are interested, the anesthesiologist will let the
research staff know of the eligible participant. During the patients wait time, the research
assistant and/or anesthesiologist will review the study, go over the consent forms and answer
any questions in regards to their participation in the study. Once the patient is consented
into the study, the research assistant and/or anesthesiologist will provide the participant
with a survey regarding their pre-epidural anxiety and pain scores. The anesthesiologist
and/or research assistant will then provide the laboring mother with a VR headset during
epidural/CSE placement by anesthesiologist. Depending on the mother's laboring timeline, if
possible, mother will receive VR feedback survey and post-epidural anxiety and pain scores.
If not, mothers will receive post-epidural anxiety and pain scores where they recall these
scores and fill out VR feedback survey postpartum.
Phase 2:
Based on preliminary and feasibility data from Phase 1, if the clinicians and study personnel
find it appropriate, the study will move on to Phase 2, a randomized prospective clinical
trial focused more broadly on technology based distractions (VR headsets) in comparison to
standard of care (no VR use) in obstetric patients for preventing anxiety and pain during
various laboring procedures. These laboring procedures include but are not limited to IV,
epidural/CSE placement and/or child-labor. Inclusion and exclusion criteria will remain the
same as Phase 1. For Phase 2, the study personnel expect to enroll 200 mothers who've been
admitted into LPCH labor and delivery services. These mothers will be approached by their
obstetric anesthesiologist during their first anesthesia consult after being admitted into
LPCH labor and delivery facilities. If they are interested, the anesthesiologist will let the
research staff know of the eligible participant. During the patients wait time, the research
assistant and/or anesthesiologist will review the study, go over the consent forms and answer
any questions in regards to their participation in the study. Once the patient is consented
into the study, the research assistant and/or anesthesiologist will provide the participant
with a survey regarding their pre-procedure anxiety and pain scores. Depending on a
randomized generator, mothers will either be placed into VR use group during procedure or
standard of care (no VR use). If mother falls under VR group, the anesthesiologist and/or
research assistant will then provide the laboring mother with a VR headset during procedure
by anesthesiologist. Depending on the mother's laboring timeline, if possible, mother will
receive VR feedback survey and post- procedure anxiety and pain scores. If not, mothers will
receive post-epidural anxiety and pain scores where they recall these scores and fill out VR
feedback survey postpartum. If mother falls under control group, mother will undergo standard
of care and receive pre and post- pain and anxiety surveys regarding procedure.
Inclusion Criteria:
- Age 18 and over
- Able to consent
- Obstetric patients who had either have a history of, planning to have, or currently
having an child laboring related procedures such as IV placement, epidural/CSE
placement and/or labor.
Exclusion Criteria:
- Inclusion Criteria:
- Age 18 and over
- Able to consent
- Obstetric patients who had either have a history of, planning to have, or currently
having an child laboring related procedures such as IV placement, epidural/CSE
placement and/or labor.
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