Immersive Virtual Reality Improves Satisfaction In Laboring Women
Phase: NA
Conditions: Labor Pain
Sponsor: Bahçeşehir University

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Cover Letter 
 
To Whom It May Concern: 
We would like to submit our protocol entitled “ Immersive Virtual Reality Improves 
Satisfaction In Laboring Women” for your consideration as a clinical trial in 
www.clinicaltrials.gov. 
All authors have contributed significantly, and that all authors are in agreement with the content 
of this trial.  
Authors state that the protocol for the research project has been approved by a suitably 
constituted Ethics Committee of the institution within which the work was undertaken and that 
it conforms to the provisions of the Declaration of Helsinki.  
Thanking you beforehand for your kind consideration. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Immersive Virtual Reality Improves Satisfaction In Laboring Women 
 
 
Objective: To evaluate the effectiveness of immersive Virtual Reality (VR) in laboring women 
on patient satisfaction as a distractive tool and pain relief. 
Methods: Randomized, controlled clinical trial with 42 laboring women allocated to VR 
intervention and control groups. Among the VR group, patient satisfaction with the use of VR 
was assessed by a Virtual Reality Satisfaction Survey and questioning whether they would 
choose VR in future labor. As a primary outcome patient satisfaction scores regarding the 
overall labor and delivery experience were compared between the two groups. A secondary 
outcome was pain assessed by a visual pain rating scale in the early and active phases of 
labor in both groups. Psychometric information was also collected from participants in each 
group using Beck Anxiety Inventory and Beck Depression Inventory.  
 
 
 
 
 
STUDY PROTOCOL 
 
Labor is a long and painful process for women. The neuraxial blockade, which includes 
epidural, spinal, and combined spinal-epidural analgesia, is presently the gold standard for 
pain control in laboring women. (ACOG Committee Opinion #295: Pain Relief During Labor : 
Obstetrics & Gynecology, n.d.) (Anim-Somuah et al., 2018) However, improving the whole 
labor and delivery experience for women is more complex and requires providing individualized 
care including alternative treatments.  
Opioid and non-opioid pharmacotherapies, patient-controlled analgesia (PCA), nitrous oxide 
are all used with variable success for labor pain. (Nanji & Carvalho, 2020) 
Acupuncture, hypnosis, yoga, hydrotherapy, massage, relaxation techniques, and 
transcutaneous electronic nerve stimulation (TENS) are among the adjuvant treatments 
provided to women in labor. (Dowswell et al., 2009; Madden et al., 2016; Smith, Levett, Collins, 
Armour, et al., 2018; Smith, Levett, Collins, Dahlen, et al., 2018) 
Recent literature indicates the successful use of immersive virtual reality (VR) for a variety of 
painful medical procedures. (Atzori et al., 2018; Faruki et al., 2019; Maani et al., 2011; 

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Mosadeghi et al., 2016; Walther-Larsen et al., 2019; Wang et al., 2020)Via wearing the VR 
goggles the user has the illusion of going inside the 3D computer-generated world and visiting 
novel environments. Immersive VR is hypothesized to reduce pain through distraction, a non-
pharmacologic attentional mechanism. The user's brain is preoccupied with the flood of 
information presented by the virtual environment restricting the mind from processing pain 
signals. (Hoffman et al., 2004) 
We hypothesized that laboring women find immersive VR as a beneficial tool for their overall 
labor and delivery experience. We randomly assigned women in labor admitted to our Labor 
and Delivery floor to a VR group or a control group.  
 
 
 
This is a randomized, controlled, single-center clinical trial in which we enrolled 42 women 
admitted during labor. The investigators randomized these women to immersive virtual reality 
(VR) or control group following their approval and written consent. This study protocol is 
approved by the Institutional Ethics Committee of Acibadem Mehmet Ali Aydinlar University 
(IRB protocol no: 2020-18/07). The primary objective of this study is to assess whether 
immersive VR was feasible and improved patient satisfaction in laboring women. We will 
assess patient satisfaction among VR users and compare patient satisfaction regarding overall 
labor and delivery experience between the two groups. Our second objective is to assess 
whether VR provided pain relief in the latent or active phase of labor. The investigators will 
also evaluate anxiety and depression in both groups on admission as potential confounders.  
The study will take place at Acibadem Maslak Hospital, a private hospital affiliated with 
Acibadem University School of Medicine in Istanbul, Turkey. Enrollment will be completed 
between November 2020 and June 2021. 
 
Participants of this study were primigravida or multigravida presenting with labor who are 
candidates for vaginal delivery with no known risk factors. The inclusion criteria were women 
between 18-42 years of age at 37-41 weeks gestation with a singleton pregnancy, vertex 
presentation, no history of chronic medical conditions, absence of pregnancy complications, 
and admission with documented labor by cervical exam and regular uterine contractions. 
Women with a diagnosis of migraine, headache, dizziness, motion sickness, epilepsy, 
psychiatric disorders, visual or auditory disabilities, history of cesarean section were excluded.  
A priori power analysis was performed to estimate the sample size with a power (1-β) of 80%, 
a significance (α) of 0.05 and an allocation ratio of 1. We assumed a neutral satisfaction score 
of 50 out of 100 (SD=12.5) for the control group and hypothesized 25% increase in satisfaction 
scores with the use of VR. A sample size of 17 subjects per group were computed to be 

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required to observe this difference. For this analysis G*Power software was used. For potential 
drop outs we decided to enroll 21 subjects in each group. Subjects were randomized to an 
intervention (VR) group (n=21) or a control group (n=21) using a random number generator 
(www.random.org).  
 
The authors will use Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system.  
Before the intervention, the authors will introduce the equipment and instruct study participants 
on how to wear and activate the headsets. Anxiety and depression scales will also be applied 
on admission.  The laboring women who enrolled in the VR group will first wear the headsets 
in early labor (Cervical dilation 3 cm) for 20 minutes. The patients will be offered to choose 
among several virtual environments including orange sunset, green meadows, black 
beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards 
printed out from the images of the Nature Trek application representing these novel immersion 
options will be provided to the patients to help them pick up their preferred environment in 
advance. The second implementation of VR headsets will be after the epidural analgesia in 
the active phase of labor for another 20 minutes (Cervical dilation 6-7cm). After the second 
intervention, the “Virtual Reality Satisfaction Survey” will be applied by the investigators.  
Patients will be asked to fill out a visual pain rating scale right before and after the VR use in 
early and active labor.  
 
For participants randomized to the control group, VR headsets will not be used and the clinic’s 
standard of care in laboring women will be followed. Anxiety and depression scales will be 
applied to each subject on admission. Participants in this group will fill out a visual pain rating 
scale both in the latent and active phases of labor. 
 
To evaluate the effectiveness of immersive VR in laboring women, the investigators will 
evaluate patient satisfaction with the use of VR among the intervention group. Patient 
satisfaction with overall labor and delivery experience and pain scores will  be compared 
between the intervention and control groups.  
Patient satisfaction with the use of VR will assess by a "Virtual Reality Satisfaction Survey", a 
10 question survey prepared by our team: with 0 being the lowest and 100 being the highest 
possible VR satisfaction score. Investigators will also ask these women whether they would 
like to use VR in future labor. Patient satisfaction with overall labor and delivery experience 
will be assessed using a Visual Analog Scale (VAS). All discharged women will be called after 
a week  following discharge from the hospital and will be asked to rate their overall childbirth 
experience on a scale from 0 to 10. Zero indicates the most negative experience possible and 
10 indicates the highest satisfaction possible. The investigators classified a score of 8 to 10 as 

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high satisfaction. Pain scores both in early and active labor in each group will be assessed 
using Wong-Baker Faces Pain Rating Scale. The scale shows a series of 6 faces ranging from 
a happy face at 0, or "no hurt", to a crying face at 5, which represents "hurts like the worst 
pain imaginable (Figure 1). 
 
Figure 1: Wong-Baker Faces Pain Scale  
 
 
Anxiety levels of study participants will be assessed with Beck Anxiety Inventory (BAI). This 
inventory consists of 21 items, each scored from 0 to 3. This is a self-report questionnaire 
measuring somatic and cognitive parts of anxiety. The total score is calculated by finding the 
sum of 21 items. A score of 0 to 7 indicates minimal anxiety, 8 to 15 mild anxiety, 16 to 25 
moderate anxiety, and 30 to 63 is associated with severe anxiety. 
For the assessment of depression in each group, Beck Depression Inventory will be used. It 
consists of 21 items which is a multiple-choice test and gives a score ranging from 0 to 63. 
Each answer is scored on a scale value of 0-3. Measures of 0–9 indicate that a person is not 
depressed, 10–18 indicates mild-moderate depression, 19–29 indicates moderate-severe 
depression and 30–63 indicates severe depression. This self-rated test estimates the signs of 
depression such as pessimism, feeling of failure, self-dissatisfaction, punishment, crying, 
insomnia.  
 
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