Clinical trial NCT03495531: Virtual Reality in Obstetric Patients
Official title: Virtual Reality Obstetrics Phase 1 & Phase 2 Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Pain
Pain
Keywords: virtual reality
obstetrics
labor procedures
regional anesthesia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

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.

Primary outcomes:
measure: Virtual Reality vs Standard Of Care
timeFrame: Throughout Study Completion, an average of 1-2 years.
Secondary outcomes:
measure: Parent/Patient Assessment of Virtual Reality Software
timeFrame: Evaluated post procedure, between 5-60 minutes after such procedure.
measure: Epidural/Combined Spinal-Epidural Dosing Requirements
timeFrame: Duration of procedure, which is generally less than 2 hours
measure: Overall Change in Pain Scores Using Virtual Reality
timeFrame: Duration of procedure, which is generally less than 2 hours
measure: Overall Change in Anxiety Scores Using Virtual Reality
timeFrame: Duration of procedure, which is generally less than 2 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: LPCH/SHC
state: California
Study officials:
References:
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citation: Dahlquist LM, Weiss KE, Law EF, Sil S, Herbert LJ, Horn SB, Wohlheiter K, Ackerman CS. Effects of videogame distraction and a virtual reality type head-mounted display helmet on cold pressor pain in young elementary school-aged children. J Pediatr Psychol. 2010 Jul;35(6):617-25. doi: 10.1093/jpepsy/jsp082. Epub 2009 Sep 28.