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IRCT20230522058251N5 IRCT 2025-10-10 Shahid Beheshti University of Medical Sciences Exploring How Virtual Reality During ACL Surgery Affects Anesthesia Use, Anxiety, Pain, and Patient Satisfaction 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 2025-09-06 anticipated 50 Complete https://irct.ir/trial/85679 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 Condition 1: Acute ACL tear - right knee. Condition 2: Acute ACL tear - left knee. Intervention 1: Intervention Group: Patients undergoing ACL reconstruction surgery who receive fentanyl and midazolam as needed during the procedure, based on the anesthesiologist’s judgment. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: Data will be available as soon as the article is published To whom: Researchers in every university, or other scientific research institutes Conditions: The data will be anonymized to ensure patient confidentiality Where to obtain: To access data please contact the corresponding author using the contact information included in the published article How to obtain: The request should be formally submitted in a formal letterhead from the university or research institute as the requesting party for the corresponding author Comments:
public Mohammad Hossein Mahrooz
Farjam
Tehran Iran (Islamic Republic of) 1964714953 +98 912 130 8261 mohamad.mahrooz@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Morteza Kazemi
Akhtar hospital, Azar dead end,Sharifimanesh st, Shariati st, Tehran
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 1072 seyyedmortezakazemi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Indication for unilateral anterior cruciate ligament repair surgery Informed consent to participate in the clinical trial Age between 18 to 65 years 18 years 65 years Both Uncontrolled systemic diseases History of seizure History of migraine History of inner ear or middle ear dysfunction S83.511A S83.512A Sprain of anterior cruciate ligament of right knee, initial encounter Sprain of anterior cruciate ligament of left knee, initial encounter Treatment - Devices Treatment - Drugs Intervention Group: Patients undergoing ACL reconstruction surgery who receive fentanyl and midazolam as needed during the procedure, based on the anesthesiologist’s judgment. 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 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. Pain. Timepoint: 10 minutes after the patient is recovered in the post-anesthesia care unit (PACU). Method of measurement: Visual Analogue Scale (VAS). 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). Patient satisfaction. Timepoint: 10 minutes after the patient is recovered in the post-anesthesia care unit (PACU). Method of measurement: Visual Analogue Scale (VAS). Shahid Beheshti University of Medical Sciences Approved 2025-05-11 Research ethics committee of vice-chancellor in research affairs - Shahid Beheshti University of Med 7th Floor, Bldg No.2 SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)