The effect of virtual reality on pain and anxiety during treatments for chronic lower back pain

ISRCTN	ISRCTN11994372
DOI	https://doi.org/10.1186/ISRCTN11994372
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Imam Abdulrahman Bin Faisal University
Funder	Investigator initiated and funded

Submission date: 09/05/2024
Registration date: 21/05/2024
Last edited: 20/05/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
One of the most common types of pain that people experience worldwide is chronic low back pain (CLBP). Chronic pain patients often turn to procedural pain management despite using all pharmaceutical pain relief options. The impact of virtual reality (VR) on pain and anxiety reduction is controversial. Some studies indicate that using VR significantly reduces these symptoms when compared to regular sedatives. Thus, this study aims to assess and compare the effects of VR distraction technologies versus anesthesia (midazolam)-based sedation among patients with CLBP undergoing painful intervention on pain and anxiety levels.

Who can participate?
Patients aged between 18 and 80 years old who are referred to the pain clinic because they are suffering from non-specific low back pain persisting for more than three months at the Intervention Unit of King Fahad University Hospital in Khobar

What does the study involve?
Patients with CLBP who meet the inclusion criteria will be randomly allocated to either sedation or VR groups. Patients in the sedation group will be given sedative medication (midazolam) while the other group will be given VR glasses to wear during the procedure. Pain, anxiety, comfort, and satisfaction scores will be measured. Hemodynamics will be monitored throughout.

What are the possible benefits and risks of participating?
Participants in the VR group will benefit from not having sedative medications that have known side effects, and instead, they will be distracted from the procedure by wearing VR glasses and watching 3D video clips.

There are minor hazards of using VR glasses including headache, and nausea.

Where is the study run from?
King Fahad University Hospital (Saudi Arabia)

When is the study starting and how long is it expected to run for?
January 2022 to May 2023

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Abrar Bakhurji, Abrar_bakhurji@hotmail.com

Contact information

Mrs Abrar Bakhurji
Public, Scientific, Principal investigator

Kingdom of Saudi Arabia
Riyadh city
13322
Saudi Arabia

Phone	+966538026888
Email	gs.vd@iau.edu.sa

Mrs Abrar Bakhurji
Public

Kingdom of Saudi Arabia
Riyadh city
13322
Saudi Arabia

Phone	+966538026888
Email	abrar_bakhurji@hotmail.com

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Impact of virtual reality on procedural pain and anxiety in chronic low back pain patients: a quasi-experimental study
Study objectives	The null hypothesis is that VR has no impact on distracting patients and reducing chronic low back pain. The alternative hypothesis: VR has a positive impact on distracting patients and reducing chronic low back pain.
Ethics approval(s)	Approved 24/04/2022, Imam Abdulrahman Bin Faisal University Institutional Review Board (Kingdom of Saudi Arabia, Khobar, 34212, Saudi Arabia; +966559420142; irb@iau.edu.sa), ref: RB-PGS-2022-01-188
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	This quasi-experimental study design will be conducted at the Intervention Unit of King Fahad University Hospital in Khobar, Saudi Arabia. Between May 2022 and May 2023, chronic low back pain (CLBP) patients meeting the inclusion criteria will enrol in the study. All patients will be randomly allocated to either the sedation (SD) group or the virtual reality (VR) intervention group. A sealed envelope was used for randomization, containing odd and even numbers from 1 to 10. The assigned nurse opened the envelope; odd numbers were set for the VR group and even numbers for the SD group. The nurse then prepared both groups of patients accordingly. Patients in the SD group will be given sedative medication (2-3 mg intravenous midazolam), while the other group will receive VR glasses. Pain, anxiety, comfort, satisfaction scores, and hemodynamics will be measured in both groups.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	(HTC)-VIVE Flow® glasses
Primary outcome measure(s)	1. Periprocedural pain intensity score measured using the numeric pain scale (with 0 denoting no pain and 10 denoting worst possible pain) before and after the procedure 2. Anxiety measured using the State-Trait Anxiety Inventory (STAI) scale before and after the procedure
Key secondary outcome measure(s)	The secondary outcome measures included: 1. Patient comfort measured using a five-point Gloucester Comfort scale, with 1 being the most comfortable and 5 being the most uncomfortable, immediately after the procedure 2. Patient satisfaction measured using a 5-point Likert scale (1 referred to dissatisfied; 2 to less satisfied; 3 to satisfied; 4 for very satisfied; and 5 for completely satisfied) once fully alert patients reach the recovery room after the procedure 3. Hemodynamic parameters: systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen saturation (SPO2), measured using by GE Aisys CS2® anesthesia machine throughout the procedure
Completion date	25/05/2023

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	30
Total final enrolment	29
Key inclusion criteria	1. Both males and females were included in the study 2. Patients who had been referred to the pain clinic because they had been suffering from non-specific low back pain persisting for more than three months 3. Patients older than 18 years old 4. American Society of Anesthesiologists (ASA) physical status classification I-III The ASA physical status classification system is a pre-operative tool that helps anticipate a patient's risks. On a scale of I to VI: I represents healthy patients with minimal risks and VI represents patients who are brain dead and whose organs tend to be donated upon approval.
Key exclusion criteria	1. Patients aged 17 years old and under 2. Patients who have visual or hearing impairments, dementia, and/or have been diagnosed with epilepsy or balance disorders.
Date of first enrolment	16/04/2022
Date of final enrolment	25/05/2023

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

King Fahad University Hospital (KFUH)

Khobar city, Saudi Arabia
Khobar
34212
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during the current study are not expected to be made available due to the privacy of the patients

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/05/2024: Study's existence confirmed by the Imam Abdulrahman Bin Faisal University Institutional Review Board.