Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy for a Multicentre Randomized Controlled Trial
Phase: NA
Conditions: Low Back Pain, Pelvic Pain
Sponsor: University of Malaga

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OFFICIAL TITLE:  
 
Virtual reality to improve low-back pain and pelvic pain during pregnancy: study 
protocol for a multicentre randomized controlled trial. 
 
NTC NUMBER: DK/NA 
 
DATE DOCUMENT: 12/06/2022 
 
 
 
 
 
 
 
 
 
 
 
 

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Authors: Francisco José García-López1*, José Manuel Pastora-Bernal2, Noelia 
Moreno Morales2, María José Estebanez-Pérez3, María del Carmen Rodríguez-
Martínez4, and Rocío Martín-Valero2 
 
1*Department of Physiotherapy, Faculty of Health Science, University of Malaga, 
29071 Málaga, Spain fjgarlop@gmail.com (F.-J.G.-L.) 
2Department of Physiotherapy, Faculty of Health Science, University of Malaga, 
29071 Málaga, Spain jmpastora@uma.es (J.-M.P.-B.) nmm@uma.es (N.M.-M.) 
rovalemas@uma.es (R.M.-V.) 
3Department of Physiotherapy, Faculty of Health Science, University of Granada, 
18071 Granada, Spain mariajoseestebanezperez@gmail.com (M.-J.E.-P.) 
4Department of Physiotherapy, Faculty of Health Science, University of Malaga, 
29071 Málaga, Spain marrodmar@uma.es (M.-C.R.-M.) 
*Correspondence: fjgarlop@gmail.com; (F.-J.G.-L.) 
 
 
 

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ABSTRACT 
A large percentage of women suffer low back and pelvic pain both during and after 
pregnancy. There are several factors to which these complaints are attributed, even 
affecting their daily lives. It is identified that many of these women do not receive adequate 
health care, however, different physiotherapeutic interventions are recommended to 
alleviate these conditions, presenting moderate levels of evidence. Virtual reality is 
presented as a complementary and promising treatment method to physiotherapy for the 
improvement of fundamental variables such as perceived pain and pain avoidance. The 
main objective is to evaluate the efficacy of a combined VR and physiotherapy program of 
4 weeks duration compared to a standard physiotherapy intervention in pregnant women 
with low back pain and pelvic pain for the improvement of pain avoidance, pain intensity, 
disability and functional level. As a secondary objective we propose to investigate patient 
satisfaction with the VR intervention. This research will be carried out by means of a 
multicenter randomized controlled clinical trial in pregnant patients residing in the 
provinces of Seville and Malaga with a diagnosis of low back pain and pelvic pain during 
pregnancy. The alternative hypothesis of this research is that the implementation of a 
Virtual Reality program together with standard physiotherapy in pregnant patients with low 
back and pelvic pain presents better clinical results obtained with the current standard 
intervention, which may represent an opportunity to define new policies and interventions 
for these pathologies and their consequences. 
 
KEYWORDS 
Virtual Reality, Physiotherapy, Low-back pain, Pelvic pain, Pregnancy 
 
 
 

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Background 
Approximately 50% of women experience low back pain (LBP) during pregnancy; 
25% continue to experience pain 1 year after delivery (1). Low-back pain (LBP) 
and pelvic pain (PP) are common during pregnancy and tend to increase as 
pregnancy advances; in some cases, the pain radiates into the buttock, leg and 
foot (2). Global prevalence is reported to range from 24% to 90%, in part, because 
there is currently no universally recognised classification system for the condition 
(3). For many women, pain can become so severe that it interferes with ordinary 
daily activities, disturbs sleep with repercussions in social and sexual life, work 
capacity and increased psychological stress and contributes to high levels of sick 
leave (4). Several factors have been identified as the possible causes of back pain 
in pregnancy. Mechanical strain secondary to enlarge gravid uterus is one of the 
causative factors which leads to compensatory lumbar lordosis (5). Besides that, 
separation of the abdominal muscles during pregnancy does contribute to 
paraspinal muscle strain. Relaxin hormone which is elevated during pregnancy is 
also identified as a causative factor. Hence, there will be an increase in joint laxity 
which may caused instability rotatory movements of sacroiliac joints (6,7).  
It is estimated that over 50% of women receive little or no intervention from 
healthcare providers (8). European guidelines recommend that LBP and PP, are 
managed by providing adequate information and reassurance to patients that it is 
best to stay active, continue normal daily activities and work if possible, and by 
offering 
individualised 
exercises 
where 
appropriate. 
Similarly, 
prenatal 
practitioners in the United Kingdom and Nordic countries give women information 
about how to manage LBP, PP or both during their pregnancy and may refer them 
to physiotherapy for a more specific treatment programme. However, in the United 
States, women are taught that LBP is a normal part of pregnancy. Interventions 
that have been used to date to help manage the pain include exercises, frequent 
rest, hot and cold compresses, abdominal or pelvic support belts, massage, 
acupuncture, chiropractic, aromatherapy, relaxation, herbs, yoga, Reiki, 
paracetamol, and nonsteroidal anti-inflammatory drugs (3,4,8,9). Other forms of 
therapy have been studied including exercise, yoga, progressive muscle 
relaxation, manual therapy, acupuncture, alone or with exercises, multi-modal 

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approach, including manual therapy, exercise and education, pelvic belts, kinesio 
tape and transcutaneous electrical nerve stimulation (TENS). A Cochrane 
systematic review and metanalisis from 2015 conclude that there is low-quality 
evidence that exercise may reduce pregnancy-related low-back pain and moderate 
to low-quality evidence suggesting that any exercise improves functional disability 
and reduces sick leave more than usual prenatal care (2). Another Systematic 
review from 2018 including 32 studies conclude that compared with not exercising, 
prenatal exercise decreased the severity of LBP, PP, during and following 
pregnancy (1). 
Some studies addressed the issue of sick leave during pregnancy, presenting 
positive results through exercise programs, reducing healthcare costs and 
promoting women´s health (10,11). Recommended physical treatments, 
particularly for persistent low back pain (>12 weeks duration), include a graded 
activity or exercise programme that targets improvements in function and 
prevention of worsening disability. Since evidence showing that one form of 
exercise is better than another is not available, guidelines recommend exercise 
programmes that take individual needs, preferences, and capabilities into account 
in deciding about the type of exercise. Some guidelines do not recommend passive 
therapies, such as spinal manipulation or mobilisation, massage, and acupuncture, 
some consider them optional, and others suggest a short course for patients who 
do not respond to other treatment (12). Other passive electrical or physical 
modalities, such as ultrasound, transcutaneous electrical nerve stimulation 
progressive relaxation, and mindfulness-based stress reduction and combined 
packages of physical and psychological treatment, for those with persistent LBP 
who have not responded to previous treatments (13–15). For patients who have 
not responded to firstline treatments, and who are substantially functionally 
disabled by pain, multidisciplinary rehabilitation programmes with coordinated 
delivery of supervised exercise therapy, cognitive behavioural therapy, and 
medication are more effective than standard treatments (13–18).  
 
A clinical practice guidelines in LBP during pregnancy in Spain suggests the use 
of aquatic exercises and other individualized exercise programs, as well as 
therapeutic massage to relieve low back pain during pregnancy (19). Furthermore, 

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physiotherapy was effective in relieving back pain by increasing the strength of the 
lumbo-sacral joint and pelvic girdle muscles (20). By introducing exercise as one 
of the treatments for back pain in pregnancy, it is hope to reduce the pain suffered 
by these women and hence reduce the morbidities associated with it. It is also aims 
to improve the quality of life (6).  
 
Virtual Reality: Virtual reality (VR) is a new technology, which has been rapidly 
evolving over the past 2 decades (21). VR can be operationally defined as 
“simulations that make use of various combinations of interaction devices and 
sensory display systems” (22,23). VR has been explored in a variety of fields and 
clinical applications. In healthcare, VR technology can be used to provide treatment 
(24), facilitate pain management (25) and rehabilitation (12) among others.  
 
A systematic review from 2019 conclude that VR has the potential to improve 
outcomes for spinal pain with demonstrated statistical and clinical significance (26). 
Additional patient populations with benefit from VR interventions include individuals 
with higher pain and physical dysfunction levels, anxiety, an alternative treatment 
to opioid analgesics (26). A randomized control trial in 80 female patients with 
breast cancer at a specialized cancer center in Jordan shown that immersive VR 
is an effective distraction intervention for managing pain and anxiety. Using 
immersive VR as an adjuvant intervention is more effective than morphine alone in 
relieving pain and anxiety (27). In stroke patients VR show promise as a future tool 
in the rehabilitation of daily live activities, particularly in the subacute phase (27).   
VR allows the user to experience the interaction with a computer-generated 
environment and the simulation of realistic environments and real-life exercises 
(26). In the rehabilitative context, motivation is an important factor influencing the 
performance outcome (26). VR constitutes an enriched environment with 
augmented multiple sensory feedbacks (auditory, visual, tactile),  with moving 
avatars, engaging several neuronal circuits that potentiate patient’s learning and 
recovery (28–30). Thus, VR may be considered a good candidate to help patients 
in improving their own movements, body position perception and reducing pain 
during the VR exercises (31).  A systematic review from 2019 focus on orthopedic 
rehabilitation conclude that the evidence of VR effectiveness is promising in 
chronic neck pain and shoulder impingement syndrome. VR and exercises have 

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similar effects in rheumatoid arthritis, knee arthritis, ankle instability, and post-
anterior cruciate reconstruction. For fibromyalgia and knee arthroplasty, the 
evidence of VR effectiveness compared to exercise is absent or inconclusive (32). 
A recent Systematic review from 2020 suggest that VR exercise has the potential 
to exert a positive impact on individual's physiological, psychological, and 
rehabilitative outcomes compared with traditional exercise (33). VR can also be 
used for various purposes in different stages of pregnancy: reducing their anxiety 
levels and training them to effectively manage their pain during labor (34), reducing 
anxiety before cesarean, episiotomy repair, dilation and curettage (35–38), 
reducing pain (29), and managing exercise training (24). 
 
Despite the fact that VR has been shown to be effective in some orthopedic 
conditions, there is no evidence about the effectiveness of VR interventions in LBP 
and PP during pregnancy. Considering the current health, it is advisable to carry 
out VR effectiveness studies in this group population both in the hospital 
environment and in other areas of care. 
Objectives 
The main objective of this research is to evaluate the effectiveness of a combined 
VR and Physiotherapy 4-weeks program compared to a standard physiotherapy 
intervention in LBP and PP pregnancy woman’s to improve pain-related fear 
avoidance, pain intensity, disability and functional level. 
 
The secondary aim is to investigate patient satisfaction with the VR intervention. 
Methods 
Study design and setting  
This research is a 4-week prospective multicentre randomized clinical trial.  
Participant recruitment and the supervised VR program component will be 
provided by clinical setting at department of Physiotherapy at University of Sevilla 
and Málaga (Spain). This research involves departments of gynecology 
rehabilitation, physiotherapy and researches from the University of Granada, 

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University of Málaga and University of Sevilla. This research follow the guidelines 
on Standards for Quality Improvement and Excellence in Reporting (SQUIRE) (39) 
and is carried out in accordance with CONSORT (Consolidated Standards of 
Reporting Trials) criteria (40). 
 
The study was approved by the institutional ethics committee of Andalucía with 
internal code 1928-N-21. All female participants must provide informed consent 
prior to enrollment in the study. 
 
Participants and elegibility criteria  
The trial includes pregnant women suffering from LBP, PP or the two in 
combination as reported symptomatically by the women or diagnosed by clinicians.  
 
Patients must live in Sevilla or Málaga during the intervention phase, patients with 
history of LBP or lumbar pathology before pregnancy or have suffered LBP or PP 
events prior to the first contact with this research. Patients will be excluded if they 
have any absolute or relative contraindications such as heart disease, chronic 
obstructive lung disease, diabetes mellitus, incompetent cervix/cerclage, multiple 
gestation, risk of premature labor, preeclampsia/pregnancy-induced hypertension, 
thrombophlebitis, pulmonary embolism, intrauterine growth restriction, or serious 
blood disease, history of abortion or curettage. Also, patients are not in full 
cognitive capacity that allows them to use new technology tools will be excluded. 
Inclusion and exclusion criteria is show in Table 1. 
 
 
 
 
 
 
 
 
 
 

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Inclusion criteria 
Exclusion criteria 
Adult woman over 18 years old 
Patients with LBP or PP pain prior to 
pregnancy. 
Pregnant woman with Low Back Pain, 
Pelvic Pain or both conditions with 
symptomatic character. 
Cognitive ability not suitable for the use of 
technological tools. 
Pregnant woman between the 12th and 
36th week of gestation, corresponding to 
the 2nd and 3rd trimester. 
Patients 
with 
absolute 
or 
relative 
contraindications. 
Pain intensity greater than 4/10 on VAS, 
indicating moderate-severe pain. 
 
Live in Sevilla or Málaga during the 
research period. 
 
 
Table 1. Inclusion and Exclusion criteria 
 
Recruitment 
In order to generate sufficient data for the development of this research a sample 
size of (n= 66) patients will be recruited based on previous and concluded RCT for 
the treatment of LBP or PP (41–43). It was calculated that a sample size of 33 
women per cohort could detect a difference in outcomes of 1.0 between the VR 
intervention and control groups, given a SD of 1.5 and a power of 0.80.  
The strategies to achieve an adequate inclusion of participants that reach the target 
sample size include the multidisciplinary collaboration of the gynecology, 
rehabilitation and physiotherapy department. The collaborators have been 
informed about the characteristics of the study in personal interviews and 
presentation. Recruitment of patients must have a socio-demographic diversity in 
relation to their social origin, gender, ethnicity and education adapted to the 
particularities of the reference population.  
Intervention 
Participants will be assigned randomly to the intervention or control groups using 
a random number table. Both groups will receive 3 sessions per week during the 4 
weeks of intervention. 

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Control Group (CG) 
Following clinical practice guidelines, subjects in the control group will receive 
multidisciplinary rehabilitation programmes with coordinated delivery of supervised 
exercise therapy, cognitive behavioural therapy (education on pain), as well as 
therapeutic massage to relieve low back pain during pregnancy.  
Typical physiotherapy session:  
- Control of daily health 
- Analgesic and muscle-relaxing (thermotherapy, tens, therapeutic massage) 
- Exercise session: 
o Initial warm-up: 5–10 min (thoracic, lumbar and pelvic joint mobility exercises 
adapted to the pregnancy progress). 
o Strengthening and flexibility exercises (thoracic, lumbar and pelvic joint 
exercises adapted to the pregnancy progress). 
o Return to calm: 5 min breath and stretching exercises 
o Recording of incidents and patient/physiotherapist feedback 
Experimental Group (EG). VR intervention: 
o Subjects in the experimental group will receive the same treatment described 
for the control group 
o  Subjects in the experimental group will receive an additional VR intervention.   
 
The immersive virtual reality (VRi) system is composed by a head mounted display 
(Oculus Quest, Facebook Inc.) and two controllers. Oculus Quest headset is a 
wireless 
and 
portable 
Android-based 
device 
which 
supports positional 
tracking with six degrees of freedom (360º). The internal cameras allow to show 
an external signal with the user view, which helps to monitoring the patient 
execution. A Wi-Fi connection and a training area of 2x2 meters are needed. 

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At the end of each session, participants will experience an immersive virtual 
landscape displayed by Nature Trek VR software (https://naturetreksvr.com/). 
First, participants will be placed in a sit down position and guided for their breathing 
control during 5 minutes (“meditation Lotus option”). After that, they will be 
encouraged to freely move around a relaxing virtual environment during 15 minutes 
taking special attention to soothing sounds of nature. The themed environment will 
be selected based on the preferences of the participants. 
At the beginning of the study, advice is given on general care, in physical activity 
and issues concerning drug intake. Patients are advised to refrain from any other 
specific training during the intervention period. Any deviations from the adherence 
and practice of the VRi are recorded daily, noting any adverse incidents. 
 
Outcomes and Instruments 
Primary research outcomes  
- Pain-related fear avoidance (FACS): The Fear-Avoidance Components Scale 
(FACS) was developed, which incorporates important components of previous FA-
related measures, and includes components of the FA model not previously 
considered in the earlier-developed questionnaires, within a framework of the most 
current FA model of Vlaeyen (44,45). The FACS has demonstrated acceptable 
test/retest reliability (r = .90–.94) and internal consistency (Cronbach α=.92) (46). 
Pain-related fear avoidance (FA), a common problem for patients with painful 
medical 
conditions, 
involves 
pain-related 
catastrophizing 
cognitions, 
hypervigilance, and avoidance behaviors, which can ultimately lead to decreased 
functioning, depression, and disability (47). 
 
- Pain intensity: (Visual Analogue Scale VAS): The VAS has been used in previous 
studies investigating changes in pain and, specifically, in all the randomized trials 
of interventions for back pain in pregnancy included in or published since the 
Cochrane and systematic reviews (42). The visual analog scale (VAS) was used 
for assessment of pain before and after the intervention. Measurement will be 
performed with a 10-cm scale marked with 1-cm increments. Pain felt by 
participants will be recorded. Pain was rated on a scale of 0 a 10, with 10 

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representing the most excruciating pain. The value indicated on the scale by the 
participants was used as the score. Previous studies have shown that the reliability 
of the VAS (r=0.76-0.84) is high (46). 
 
- Disability and Physical function: In this paper, we focus on the 2 back-specific 
measures of function recommended in the “core-set,” the Roland-Morris disability 
Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). They are the most 
commonly used measures of function in back pain research (46). 
 
The RMDQ will be used for measurement of the severity of disability in participants 
who had less severe LBP. There are 24 categories comprised of yes or no 
questions. Each participant can have a maximum score of 24. Scoring closer to 24 
indicates greater functional disability (48,49). Quoted test-retest correlations 
include 0.91 (same day), 0.88 (1 week), and 0.83 (3 weeks) (48). 
 
The Oswestry low-back pain disability index (ODI) will be completed by the 
participants and included 10 questions assessing activities of daily living in order 
to examine the functional level when experiencing LBP. Each category will be 
scored from zero to five with regard to the severity of disability caused during daily 
life. The intraclass correlation coefficient was r=0.938, and the Cronbach´s alpha 
was 0.918 (day 1) and 0.895 (day 7) in the validation (44,45). 
 
Secondary research outcomes  
- Satisfaction with Virtual Reality intervention 
 
To assess the Satisfaction with the Virtual Rehabilitation Systems we will use the 
USEQ (User Satisfaction Evaluation Questionnaire). The USEQ is a questionnaire 
that is designed to properly evaluate the satisfaction of the user (which constitutes 
part of usability) in virtual rehabilitation systems. The USEQ is a reliable 
questionnaire with adequate internal consistency, Cronbach alpha coefficient was 
0.716, and patients found the USEQ to be an easy-to-understand questionnaire 
with a convenient number of questions (50). 
 

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Primary and Secondary 
Outcomes 
Definition 
Type 
Pain 
related 
fear 
avoidance 
FACS 
Self-reported 
Pain intensity 
VAS 
Registered / Self-reported 
Disability 
and 
physical 
function 
RMDQ, ODI 
Registered / self-reported 
Satisfaction and usability 
USEQ 
Self-reported 
 
Table 2. Primary and Secondary Outcomes 
 
Data collection, monitoring, and management 
Once participants have been informed and agree to participate in the study, data 
will be collected for statistical analysis. This data collection will take place in the 
period September-December 2022. Initial assessment (Pre) and final 4-week 
assessment (Post) will be carried out by the research team including, rehabilitation 
and physiotherapy department. The data will be aggregated to research database 
created for this purpose and managed by the principal’s researches using 
exportable data tables for statistical analysis.  
 
The research is designed in 4 stages as presented at Figure 1 study design flow 
diagram: 
 
Stage 1 includes 2 different processes: firstly the identification of candidates, the 
provision of prior information and the signing of informed consent if subjects agree 
to participate. Secondly, the assessments by the physiotherapy department. The 
initial assessment includes a self-made clinical interview for anamnesis with self-
administered questionnaires, which will be completed including FACS, RMDQ, ODI 
and VAS (T0-Pre). This stage ends with the referral to the physiotherapy 
intervention team. 
 

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Stage 2 includes: Design of a personalised physiotherapy programme (CG and 
EG) according with Physiotherapy department plus VRi intervention in the (EG). 
 
Stage 3 includes: 4 weeks physiotherapy intervention plus VRi program with the 
supervision of the physiotherapy department. Initials 1 to 1 session is offered with 
technology management and patient education. Daily follow up sessions include 
the progression and adverse events records. Physiotherapy team will updates 
programmes according to participant’s feedback. 
 
Stage 4 includes: Final assessments and evaluation (T1-Post).  At this stage 
Physiotherapy team and principals researches compile the results of outcomes 
after 4 weeks including FACS, RMDQ, ODI, VAS and USEQ. Satisfaction 
questionnaire will be added to research data’s for statistical analysis. 
 
Statistical analysis 
This research is a multicentre prospective controlled trial pre/post design. The 
results of the trial research will be presented as a summary of the outcome 
measures, together with the estimated effect size and precision. Statistical analysis 
will be performed according to the intention-to-treat principle. Patient 
characteristics will be summarized using frequencies and percentages for 
categorical factors, and using means and standard deviations for continuous 
measures in order to have as much information as possible available for 
exploration and analysis. The effect sizes will be calculated using the Cohen's d so 
that the results can be compared to other studies. The outcome measures will be 
compared before and after the completion of the 4 weeks program. All statistical 
analyses will be conducted using SPSS software. Statistical significance was set 
at p < 0.05. 
 

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Figure 1. Study design flow diagram: Enrollment, assessments and intervention stages 
 
Results: 
Enrollment began in September 2022. First study results will be reported at the end 
of 2022. The results of this study will determine if a larger-scale intervention is 
feasible. Further, this pilot study will be the first to examine the effect of the VR 
intervention on LBP and PP in pregnancy woman. If the results confirm beneficial 
Enrolment 
Adult pregnant woman over 18 years old, 
with pain intensity greater 4/10 on VAS in 
LBP, PP or both conditions between the 
12th and 36th week of gestations. Residing 
in Sevilla or Málaga 
Stage 1. Identifications of candidate and 
Physiotherapy Assessment 
- 
Prior information, informed consent 
- 
Assessment by physiotherapy department  
Pain Related Fear Avoidance, 
Pain Intensity, Disability and 
Physical Function  
(T0-Pre) 
Stage 2.  Personalised physiotherapy programme 
- 
Design and development of the physiotherapy 
intervention for CG and EG programme 
Stage 3. Intervention (4 weeks) 
- 
EG Physiotherapy + VRi intervention (technology 
management and patient education) 
- 
CG Physiotherapy (Patient education) 
- 
Daily Follow-up sessions, progression and 
incidents records 
- 
Intervention updates according to patient 
feedback 
Stage 4. Final Assessments (After 4 weeks 
programme) 
- 
Final Physiotherapy Assessment 
- 
Research Data Collection (Principal 
Researches) 
Pain Related Fear Avoidance, 
Pain Intensity, Disability and 
Physical Function  
Satisfaction with VR 
intervention, Data Analysis. 
(T1-Post) 
Adverse event records, 
progression and Physiotherapy 
programme updates (exercise 
modifications) 

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effects in the outcomes, this study will add more evidence in support of the use of 
VR program as an effective tool in pregnancy with LBP and PP rehabilitation 
programs. 
Discussion: 
Evidence from single studies suggests that some therapy modalities or a multi-
modal intervention (manual therapy, exercise and education) improves pelvic pain 
and pregnancy related outcomes. However, the current scientific evidence leaves 
many issues unresolved like type and intensity of exercise and physiotherapy 
intervention effectiveness for different outcomes. Since evidence showing that one 
form of exercise is better than another is not available, guidelines recommend 
exercise programmes that take individual needs, preferences, and capabilities into 
account in deciding about the type of exercise. This lack of standardized exercise 
programmes may lead to significant intervention biases in the different studies and 
consequently the low or moderate level of evidence. 
Due to the high prevalence, the recurrence, the interference on daily activities, 
work capacity and sick leaves, and the increased psychological stress (1–4), low 
back pain is undoubtedly the key clinical sign to address in this population. 
The VRi used in this case may alleviate pain by distracting the patient’s attention 
from pain. The alleviation of pain is thought to be the psychological effect of 
immersion in the virtual space created by the VR technology (51). Another 
mechanism by which the VR program can reduce pain would be the creation of a 
relaxing atmosphere. Perception of pain is influenced by the patient’s affect (52). 
Therefore, the positive effect induced by the psychological effects of the VR 
relaxation program could suppress pain perception (53).  
This research should provide knowledge about the possibility of implementing 
VR programs in clinical environment, identifying new intervention opportunities 
in this group of patients.  
Technical problems like device failures and technological difficulties may arise 
in connection with the use of VR technology. However, staff members are 
available to provide technical support. As possible adverse events we consider 

17 
 
 
the lack of improvement and positive evolution of the patient. We also consider 
as an adverse event the performance of exercise with excessive workload. 
Patients will be informed of the importance of warning the health professional of 
any incident or setback in their recovery and their right to withdraw from 
participation in the research at any time. 
Future lines of research would involve the development of clinical trials with a 
large sample size and the opportunity to develop a multicenter randomized 
clinical trial with standardize physiotherapy and exercise programmes 
Conclusions:  
This study protocol is the first to examine the effect of a VR intervention added 
to physiotherapy in LBP and PP in a multicentre clinical setting. Efficacy and 
satisfaction must show if this study will add more evidence in support of the use 
of VR as an effective tool in pregnancy women. 
Ethical aspects 
This project will be carried out following the guidelines of the Declaration of 
Helsinki (Fortress 2013) and the Standards of Good Clinical Practice. Personal 
data will be processed according to REGULATION (EU) 2016/679 OF THE 
EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the 
protection of natural persons with regard to the processing of personal data and 
on the free movement of such data¿ and the Organic Law 3/2018 of 5 December 
on the Protection of Personal Data and Guarantee of Digital Rights (54). Only 
researchers will have access to the research data. The information collected 
from each subject will be associated with a numerical identification code and will 
be the only identification of the patient for the purposes of data processing and 
analysis.  
This trial has the approval of the Andalucía Ethics Committee with HIP version 
1928-N-21. 
Informed Consent Statement:  

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Participants in the study are required to read and approve the consent form by 
signing the previous information for patients and the consent form. They will also 
be informed of the possibility of revoking the consent given at any time, without 
having to justify their decision and without prejudice.  
Confidentiality of data: The Researcher declares that follows the protocols of his 
work centre regarding the publication of data in accordance with the provisions of 
Organic Law 3/2018, of 5 December, on the Protection of Personal Data and 
Guarantee of Digital Rights, and that the data will be incorporated into a file for the 
purpose of carrying out this research project. 
 
Conflict of interest. 
No conflict of interest 
 
 

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24 
 
 
APPENDIX I. INFORMED CONSENT 
Informed Consent - Patient's Written Consent 
I (Name and Surname): ............................................................................... 
 
1. I declare that I have read the Patient Information Sheet that accompanies 
this consent. 
2. I have been able to ask questions about the study. All questions were 
answered to my satisfaction. 
3. I have spoken with the reporting health care professional: 
...................................... 
4. I understand that my participation is voluntary and I am free to participate 
or not in the study. 
5. I have been informed that all data obtained in this study will be confidential 
and will be treated in accordance with the Organic Law on Personal Data 
Protection 3/2018. 
6. I understand that I can withdraw from the study: 
- Whenever I want 
- Without having to give explanations 
- Without affecting my medical care. 
 
I freely give my agreement to participate in the project entitled 
I GIVE                   
I DO NOT GIVE  
Signature of the patient  
Signature of the informing health professional 
Name and surname:……………….  
 
   Name and surname:……….. 
Data:……………………………  
   Data:……………………… 
 

25 
 
 
APPENDIX II. PREVIOUS INFORMATION FOR THE PATIENT 
TITLE: "Virtual reality to improve low back and pelvic pain during 
pregnancy: study protocol for a multicenter randomized controlled trial". 
Department of Physiotherapy, Faculty of Health Sciences, University of 
Granada. Principal Research: Francisco José García López, 
fjgarlop@gmail.com, Tf: 695 33 29 91 
WHY ME? Because you are over 18 years of age and have recently 
been selected by …………………….So the research team has 
considered that you can benefit from the means offered to you from this 
research project.  
WHAT DOES THE PROJECT CONSIST OF? An intervention accepted 
and validated by the scientific community is applied. Similar studies 
have shown that it can be a beneficial tool and that it can have positive 
effects or in any case never be detrimental to your condition. We want 
to test its effectiveness in certain patients, as well as to know if its 
implementation is satisfactory. 
HOW ARE THE PARTICIPANTS ORGANIZED AND WHAT DOES 
THE INTERVENTION CONSIST OF? 
Participants will be randomly assigned to the intervention or control 
groups through the generation of random numbers by means of 
computer software. Both groups will receive 3 sessions per week for 4 
weeks of intervention. Subjects in the experimental group will receive 
the same treatment as described for the control group, consisting of: 
multidisciplinary rehabilitation program, supervised exercise therapy, 
cognitive-behavioral therapy and therapeutic massage for pain relief. 
Subjects in the experimental group will receive an additional VR 
intervention at the end of the conventional physical therapy session.  
CAN IT CAUSE ME DISCOMFORT? 

26 
 
 
This intervention does not have to produce discomfort, beyond the 
sensations typical of a physiotherapy rehabilitation. In any case, if you 
feel even the slightest sensation, let your consultant know and you will 
be informed of the care you will receive.  
WHAT HAPPENS IF I DECIDE TO APPLY OTHER MEASURES IN 
ADDITION?  
Your consultant will inform you during the research period what type of 
medical care you will receive and how you should report any other type 
of intervention that may influence the results. 
WHAT HAPPENS AFTER THE WEEKS OF INTERVENTION?  
Your consultant during the research period will inform you of the 
recommendations to follow once the intervention is over. 
IF I DON'T FEEL LIKE IT, I CAN'T, I DON'T WANT TO CONTINUE IN 
THE STUDY, WHAT HAPPENS? You can decide at any time your 
inclusion or exclusion from the project without giving any explanation if 
you wish to do so. 
WHAT GUARANTEES DO I HAVE IF I DECIDE TO PARTICIPATE?   
In addition, the monitoring will be exhaustive by researchers with more 
than 20 years of professional experience. 
Basic information on Data Protection 
In accordance with the provisions of Regulation (EU) 2016/679 of the 
European Parliament and of the Council, and of the Organic Law on 
Personal Data Protection 3/2018 and Guarantee of Digital Rights we 
inform you that the personal data provided will be processed exclusively 
by the Principal Investigator and members of the research team.  
Rights: you have the right to access, rectify and delete the data, as well 
as other rights that you can exercise by contacting the address 
fjgarlop@gmail.com.