1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response (Others) -  Google drive


6. For how long will this data be available start date provided 13-04-2025 and end date provided 13-12-2040?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Background/ Introduction

• Endoscopy refers to the internal examination of a canal or hollow viscus using specialized instruments like an endoscope, often requiring analgesics for patient comfort.
• Pan endoscopy is a diagnostic technique that allows for the visualization of the upper gastrointestinal (GI) tract extending to the duodenum. Also known as OGD, upper endoscopy, gastroscopy, or simply endoscopy, this procedure is used to examine the oesophagus, stomach, duodenum, as well as the biliary and pancreatic tracts.
• Virtual reality (VR) has proven to be a valuable tool for mitigating autonomic pain responses, as evidenced by its use in procedures like cervical conisations and cone biopsies. VR has multiple applications in healthcare, particularly in managing pain.
• Research shows that VR significantly reduces anxiety, with a notable decrease observed after 45 minutes of use compared to the control group, and even greater reduction after 90 minutes^1.
• Additionally, VR has been effective in alleviating somatic pain in areas such as the abdominal wall, legs, arms, neck, and head during outpatient surgeries. Its benefits have been validated across various medical fields, including psychology, dentistry, and rehabilitation.

Objectives:

Primary objectives

1.     To assess the effectiveness of Virtual reality assisted immersive distraction in invasive medical procedures such as endoscopy by comparing the comfort, pain, anxiety, and patient satisfaction levels in patients undergoing endoscopies with and without Virtual reality assistance.

Secondary objectives

2.     To assess the physician related stress levels in a scale of 0-3 while operating on Virtual reality assisted group of patients’ vs Non virtual reality assisted group of patients.

Review of Literature:

v Authors (Year): José Luis Mosso Vázquez, Brenda K. Wiederhold, Ian Miller, Mark D. Wiederhold
Affiliations:

1.     School of Medicine, Universidad Panamericana, Mexico City, Mexico

2.     The Virtual Reality Medical Centre, San Diego, CA, USA

3.     The Virtual Reality Medical Institute, Brussels, Belgium

4.     Interactive Media Institute, San Diego, CA, USA

Key Findings:

o   This study explored the effectiveness of virtual reality (VR) in managing pain and reducing visceral or autonomic responses during diagnostic upper gastrointestinal (GI) endoscopies in 115 cases.

o    It was found that VR significantly reduced visceral responses during endoscopies of the oesophagus, stomach, and duodenum, resulting in lower overall pain levels compared to the control group, with a moderate effect size.

o   Additionally, physician stress decreased, leading to more accurate procedures and shorter procedure times. All 115 endoscopies using VR were performed without complications.

v Authors (Year): Angela Li, Zorash Montaño, Vincent J Chen, Jeffrey I Gold
Affiliations:

1.     Children’s Hospital Los Angeles, Departments of Anaesthesiology Critical Care Medicine & Radiology, Los Angeles, CA, USA

2.     Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

Key Findings:

·       The use of VR glasses during colonoscopy was well-received by patients and did not affect the technical success of the procedure. Patients found the VR experience enjoyable and distracting, enhancing their overall comfort.

v Authors (Year): Govert Veldhuijzen, Nienke J.M. Klaassen, Richard J.A. Van Wezel, Joost P.H. Drenth, Aura A. Van Esch
Affiliations:

1.     Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, Netherlands

2.     Department of Radiology and Nuclear Medicine, Radboud University Medical Centre, Nijmegen, Netherlands

3.     Department of Biomedical Signals and Systems, University of Twente, Enschede, Netherlands

Key Findings:

·       In a study of 19 patients, including 10 who were given VR glasses, the use of VR was accepted without increasing procedural time.

·        No issues with communication or patient positioning were reported.

·        Patient comfort, pain, anxiety, and satisfaction levels were similar between those who used VR glasses and those who did not, with patients noting a pleasant distracting effect.

v Authors (Year): Ali Asad Khan, Anam Ali, Ali Salman Khan, Yasir Shafiq, Mohsin Masood, Fatima Irfan, Sajid Abaidullah
Affiliations:

1.     North Medical Ward, King Edward Medical University, Lahore, Pakistan

2.     Department of Developmental and Behavioral Paediatrics, University of Child Health Sciences, The Children’s Hospital, Lahore, Pakistan

3.     Acute Medical Unit, North Manchester General Hospital, Manchester, England

Key Findings:

·       This randomized controlled trial investigated how visual aids impact state anxiety, fear, and stress in patients undergoing endoscopy.

·        It was found that psychological counselling combined with visual aids before the procedure could help reduce anxiety, acute stress, and fear, with visual aids contributing additional benefits in lowering anxiety scores.

Materials & Methods:

Study Duration: 6 Months

Funding Information & Budget:

Total Estimated Budget: Self-funded (Indian rupees RS.10,000)

Study design: A RANDOMISED SINGLE BLIND CLINICAL TRIAL

Study setting: Department of General surgery, Karpaga Vinayaka institute of Medical sciences , Madhuranthagam

Study duration: six months

Study population: Patients elective endoscopy

Inclusion criteria & Exclusion criteria:

The study included adults and individuals scheduled for elective endoscopy procedures.

Elective Indications of Endoscopy²:

·        Achalasia

·        Barrett’s esophagus

·        Caustic injury

·        Esophageal cancer

·        Esophageal strictures

·        Esophageal varices

·        Foreign bodies

·        Gastric epithelial polyps

·        Peptic ulcer disease

·        Gastroesophageal Reflux disease

·        Gastric cancer

·        Ampullary adenoma

·        Nonampullary duodenal adenoma

·        FAP/hereditary nonpolyposis colorectal cancer

·        Inflammatory Bowel disease

·        Percutaneous endoscopic gastrostomy

·        Upper GI bleeding

·        Obscure GI bleeding

·        Pernicious anemia

·        Bariatric weight loss surgery

The study excluded participants who had visual or auditory impairments, dementia, limited proficiency in Tamil, or a diagnosis of balance disorders or epilepsy.

Sampling:

a.      Sampling frame: Six months (  October 2024-April 2024)

b.     Sampling method: Purposive sampling

c.      Sample size with calculation methods:

d.     Sample Size Calculation

 Ali Asad Khan et al. (2023) reported the endoscopy-related after intervention for anxiety and stress (video) in two groups, with mean and standard deviation considered as group I Anxiety (4.44, 0.16) and group II stress (11.80, 0.23) in the most recent edition of Annals of Medicine. Based on this as a reference and a 95 % confidence interval, the mean difference between the two groups will be 1.0 and the minimum sample size will be 612 ~ 620.

Source Details: Ali Asad Khan, Anam Ali, Ali Salman Khan, Yasir Shafi, Mohsin Masud, Fatima Irfan and Sajid Abaidullah (2023), “Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial”, Annals of Medicine, 2023, Vol. 55, no. 1, 1234–1243.

Sampling:

a.      Sampling frame: Six months (  October 2024-April 2024)

b.     Sampling method: Purposive sampling

c.      Sample size with calculation methods:

d.     Sample Size Calculation

 Ali Asad Khan et al. (2023) reported the endoscopy-related after intervention for anxiety and stress (video) in two groups, with mean and standard deviation considered as group I Anxiety (4.44, 0.16) and group II stress (11.80, 0.23) in the most recent edition of Annals of Medicine. Based on this as a reference and a 95 % confidence interval, the mean difference between the two groups will be 1.0 and the minimum sample size will be 612 ~ 620.

Source Details: Ali Asad Khan, Anam Ali, Ali Salman Khan, Yasir Shafi, Mohsin Masud, Fatima Irfan and Sajid Abaidullah (2023), “Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial”, Annals of Medicine, 2023, Vol. 55, no. 1, 1234–1243.

 Sampling:

g.     Sampling frame: Six months (  October 2024-April 2024)

h.     Sampling method: Purposive sampling

i.       Sample size with calculation methods:

j.      Sample Size Calculation

 Ali Asad Khan et al. (2023) reported the endoscopy-related after intervention for anxiety and stress (video) in two groups, with mean and standard deviation considered as group I Anxiety (4.44, 0.16) and group II stress (11.80, 0.23) in the most recent edition of Annals of Medicine. Based on this as a reference and a 95 % confidence interval, the mean difference between the two groups will be 1.0 and the minimum sample size will be 612 ~ 620.

k.       Source Details: Ali Asad Khan, Anam Ali, Ali Salman Khan, Yasir Shafi, Mohsin Masud, Fatima Irfan and Sajid Abaidullah (2023), “Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial”, Annals of Medicine, 2023, Vol. 55, no. 1, 1234–1243.

Study tools:

1.     Endoscopic Instrument

Endoscopic instrument are specialized tools used in rndoscopy procedures to examine the interior of hollow organs and cavities within the body .They include

·       Endoscope: This is the primary instrument used in endoscopy. It is a flexible or rigid tube equipped with a light source and a camera at its tip. Endoscopes come in various types and sizes, depending on the specific area of the body being examined.

·       Biopsy Forceps: These are small, pincer-like instruments used to take tissue samples (biopsies) during an endoscopic procedure. Biopsy forceps come in different shapes and sizes to accommodate various anatomical locations and tissue types.

·       Graspers: These instruments have a grasping mechanism at their tip, allowing the endoscopist to manipulate tissues or objects within the body cavity. Graspers are used for tasks such as repositioning organs, retrieving foreign objects, or assisting with therapeutic interventions.

·       Scissors and Knives: Endoscopic scissors and knives are used for cutting tissues, dissecting lesions, or performing incisions as part of therapeutic procedures.

·       Light Sources and Video Processors: These are external components of the endoscopic system that provide illumination and process the images captured by the endoscope’s camera. They play a crucial role in achieving high-quality visualization during endoscopic procedures

2.     METAQUEST OCULUS 2 .

The META QUEST 2  is a type of head-mounted display manufactured by Facebook Corporation. It is designed to provide users with a high-resolution immersive viewing experience, often used in applications such as virtual reality (VR), simulation, training. augmented reality .

Key features of the Metaquest Oculus 2 may include:

a.     High Resolution: The MetaQuest Oculus 2s typically offer high-resolution displays, providing crisp and detailed visuals to the user.

b.     Compact Design: They are often designed to be lightweight and compact, allowing for comfortable long-term use.

c.      Wide Field of View (FOV): MetaQuest Oculus 2 models may offer a wide field of view, providing users with a more immersive visual experience.

d.     Head Tracking: Many MetaQuest Oculus 2 incorporate head-tracking technology, allowing users to interact with virtual environments by moving their head.

e.      Stereo Vision: The displays in MetaQuest Oculus 2 often provide stereo vision, enabling depth perception and enhancing the realism of virtual environments.

f.       Integration: MetaQuest Oculus 2s can be integrated with various hardware and software systems, making them versatile for use in different applications and industries.

g.     Customization Options: Depending on the model, MetaQuest Oculus 2s may offer customization options such as adjustable straps, diopter adjustments for focus, and compatibility with accessories like headphones or prescription lenses.

Overall, the MetaQuest Oculus 2 is a sophisticated tool for delivering immersive visual experiences across a range of applications, including entertainment, gaming, education, healthcare, and industrial training.

3.     Gauze

4.     1% Xylocaine spray

Data collection procedures:

• In this study, we perform diagnostic esophagogastroduodenoscopy (OGD) with biopsies on patients.
• The study includes individuals visiting the outpatient or emergency departments with conditions such as peptic ulcer disease, gastritis, oesophageal reflux, upper gastrointestinal bleeding, duodenogastric reflux mentioned in the inclusion criteria.
• Participants complete a baseline survey on a tablet, providing demographic information, prior endoscopic and virtual reality (VR) experience, and responses to a validated general health questionnaire (RAND-36).
• On the Day of the procedure ,15 minutes before the procedure, patients receive a second survey that includes validated questionnaires on anxiety (STAI) and pain.
• To prepare the VR group, they undergo training on how to navigate the relaxation environment before the procedure.
• Throughout the endoscopy, we monitor each patient’s vital signs and pain levels using the Visual Analogue Scale (VAS) for self-reporting. Initially, while seated, we record their vital parameters such as Heart rate, Blood pressure , Oxygen saturation and pain levels.
• The endoscopy is performed under local anaesthesia, with the surgeon applying five doses of xylocaine spray to the oral cavity before starting.
•  The patient is positioned on their left side with an oral protector (nozzle), and the METAQUEST OCULUS 2 is set up to display any one of four virtual environments.
• The endoscope is then inserted through the oral cavity into the larynx, and the patient is asked to swallow to assist with the endoscope’s entry into the upper oesophagus.
• Once the VR headset and environment are activated, the patient begins navigation.
• During the exploration of the stomach and gastric antrum, the endoscopist performs a retro vision manoeuvre.
• Due to potential discomfort from the endoscope bending, we record vital signs and pain levels at this point.
• Necessary tissue biopsy samples are taken
• The procedure continues with examination of the first and second portions of the duodenum, during which vital signs are assessed again.
• The VR group remains in the virtual reality setting for 10 minutes post-procedure.
• During this period, we record the concluding  vital signs, pain ratings.
• Physician stress is assessed using a self-analysis scale from 1 to 3 (Where 1  is indicative of no stress, 2  is indicative of some stress, 3is indicative of  much stress), and the duration of the procedure is also documented.

5. Rand-36 SCALE⁴

6. VISUAL ANALOGUE SCORE ⁵

7. State -Trait Anxiety scale

8.Randomization:

• Patients are assigned to one of the two groups using a computer-generated random sequence with a block size of 4.

• To conceal allocation, sealed, opaque envelopes are used.

 These envelopes are numbered sequentially and contain slips marked with "V" for the VR (Experimental) group or "NV" for the Non-VR (Control) group.

• Patients are distributed into the VR or Non-VR group in a 1:1 ratio according to the codes indicated on the slips in the envelopes they draw.

9.Post-op care, Data recording and Data- ANALYSIS:

• Following the procedure, all patients are transferred to the post-operative ward.
• Data collection and monitoring of progress are managed using the SURGILOG Android application.
•  For data analysis, IDM SPSS STATISTICS software version 24 is utilized.

10.Video reference Selection criteria:

·       Experts from the Departments of General Surgery, Psychiatry, and Music evaluated the appropriateness of the video.

·       The video link was shared with these experts, and revisions were made based on their feedback.

·       The intervention was initially tested with ten patients scheduled for endoscopy, and their feedback on the visuals, music, and VR headset was positive.

Additionally, the intervention underwent pretesting and pilot testing with ten patients scheduled for endoscopy to assess its feasibility and effectiveness