Assessing the Impact of Intra-operative Virtual Reality Immersion on Anesthetic Consumption, Anxiety, Pain and Patient Satisfaction in Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial
Evaluating the effectiveness of immersive virtual reality as an intra-operative pain and anxiety management method in ACL reconstruction surgery
Design
A two-arm parallel group randomized clinical trial, non-blinded, phase 3, with a sample size of 25 patients in each group, utilizing a pool of opaque sealed envelopes for randomization.
Settings and conduct
The research will take place at Akhtar Hospital in Tehran. Patients assigned to the virtual reality group will be exposed to a tranquil virtual environment. They will receive comprehensive explanations regarding the procedure and reassurances that they have the option to halt the use of the virtual reality goggles at any point during the procedure if they experience any adverse effects like nausea, vomiting, or headaches. The experiment will utilize the Oculus Quest 2 virtual reality headset, displaying serene landscapes encompassing plains, forests, and seas, accompanied by calming music played for the patient in the operating room.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ACL reconstruction surgical operation indication, informed consent, age between 18 to 65 years. Exclusion conditions: Any uncontrolled systemic disease, history of seizures, history of migraines, inner or middle ear disorders
Intervention groups
Virtual Reality Group: Patients undergoing ACL reconstruction surgical procedures who are immersed in a calming virtual reality environment during surgery using a virtual reality device. Control Group: Patients undergoing ACL reconstruction surgical procedures in the usual manner without utilizing the virtual reality device
Main outcome variables
The amount of anesthetic drugs used during the surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230522058251N5
Registration date:2025-10-10, 1404/07/18
Registration timing:registered_while_recruiting
Last update:2025-10-10, 1404/07/18
Update count:0
Registration date
2025-10-10, 1404/07/18
Registrant information
Name
Mohammad Hossein Mahrooz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 130 8261
Email address
mohamad.mahrooz@alum.sharif.edu
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-06, 1404/06/15
Expected recruitment end date
2025-12-06, 1404/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Impact of Intra-operative Virtual Reality Immersion on Anesthetic Consumption, Anxiety, Pain and Patient Satisfaction in Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial
Public title
Exploring How Virtual Reality During ACL Surgery Affects Anesthesia Use, Anxiety, Pain, and Patient Satisfaction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Indication for unilateral anterior cruciate ligament repair surgery
Informed consent to participate in the clinical trial
Age between 18 to 65 years
Exclusion criteria:
Uncontrolled systemic diseases
History of seizure
History of migraine
History of inner ear or middle ear dysfunction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was carried out using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher not otherwise involved in the trial. The random allocation sequence was generated in advance using a table of random numbers and arranged in blocks of variable size to ensure balanced allocation between the study arms. Each envelope contained a single assignment slip indicating the intervention group. The envelopes were identical, tamper-proof, and stored in a secure location. At the time of enrollment, once eligibility was confirmed and informed consent obtained, each participant opened the next envelope in sequence to determine the allocation, which was then recorded by the recruiting investigator.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of vice-chancellor in research affairs - Shahid Beheshti University of Med
Sprain of anterior cruciate ligament of right knee, initial encounter
2
Description of health condition studied
Acute ACL tear - left knee
ICD-10 code
S83.512A
ICD-10 code description
Sprain of anterior cruciate ligament of left knee, initial encounter
Primary outcomes
1
Description
The amount of anesthetic drug administered to the patient
Timepoint
After entering the operation room and during the surgical procedure
Method of measurement
The amount of Midazolam or Fentanyl injected to the patient as recorded in the surgery report note
Secondary outcomes
1
Description
Pain
Timepoint
10 minutes after the patient is recovered in the post-anesthesia care unit (PACU)
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Anxiety during surgery
Timepoint
10 minutes after the patient is recovered in the post-anesthesia care unit (PACU)
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
3
Description
Patient satisfaction
Timepoint
10 minutes after the patient is recovered in the post-anesthesia care unit (PACU)
Method of measurement
Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention Group: Patients undergoing ACL reconstruction surgery who receive fentanyl and midazolam as needed during the procedure, based on the anesthesiologist’s judgment.
Category
Treatment - Devices
2
Description
Control group: Candidates for ACL reconstruction surgery who during the surgery, receive fentanyl and midazolam according to the standard protocol and under the supervision of the anesthesiologist
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar orthopedic hospital
Full name of responsible person
Seyed Morteza Kazemi
Street address
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
akhtarhospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Morteza Kazemi
Street address
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
akhtarhospital@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Mahrooz
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Farjam
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 912 130 8261
Fax
Email
mohamad.mahrooz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Morteza Kazemi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
seyyedmortezakazemi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Mahrooz
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Farjam
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 912 130 8261
Fax
Email
mohamad.mahrooz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data in this study include patients' age, sex, type of surgery, duration of the procedure, the type and amount of anesthetic drug administered, pain, anxiety, and patient satisfaction. All data will be anonymized to ensure patient confidentiality
When the data will become available and for how long
Data will be available as soon as the article is published
To whom data/document is available
Researchers in every university, or other scientific research institutes
Under which criteria data/document could be used
The data will be anonymized to ensure patient confidentiality
From where data/document is obtainable
To access data please contact the corresponding author using the contact information included in the published article
What processes are involved for a request to access data/document
The request should be formally submitted in a formal letterhead from the university or research institute as the requesting party for the corresponding author