Impact of Virtual Reality on Patient's Anxiety Who Underwent Surgery Uner Regional Anesthesia

NCT06061198 | Completed

• 1 other identifier: UHMahdia
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

this study was conducted in TAHER SFAR Hospital . it included 68 patients and it aims to evaluate the impact of virtual reality on patients undergoing upper limb surgery under regional anesthesia and evaluate the consumption of hypnotics during surgery , anxiety levels and patients satisfaction. this study contain 2 arms , each arm contain 34 patients . first arm received regional anesthesia and surgery under virtual reality using a VR gear . second arm received standard care

Conditions

Anxiety; Satisfaction, Patient

Keywords

virtual reality; anxiety; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• hypnovel consumption during surgery

  the required dose of Midazolam for a LIKERT intraoperative anxiety score goal \< 2

  From enrollment to the end of treatment at 10 weeks

Secondary Outcomes (9)

• satisfaction level during surgery

  at the end of the procedure

• pre-operative patients's anxiety level by LIKERT score

  From enrollment to the end of treatment at 10 weeks

• per-operative patients's anxiety level by LIKERT score

  From enrollment to the end of treatment at 10 weeks

• post-operative patients's anxiety level by LIKERT score

  From enrollment to the end of treatment at 10 weeks

• vitals : systolic pressure

  From enrollment to the end of treatment at 10 weeks

Study Arms (2)

group of patients who underwent surgery with the virtual reality experience

ACTIVE COMPARATOR

patients underwent surgery wearing a virtual reality mask

Device: a virtual reality device

patients who underwent surgery in standard conditions without the virtual reality experience

NO INTERVENTION

patients underwent surgery without a virtual reality mask

Interventions

a virtual reality device DEVICE

the patient will wear a masque tht will provide a virtual reality experience using a VR Gear connected to a mobile phone through an application installed on the mobile phone

group of patients who underwent surgery with the virtual reality experience

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient classified ASA 1 , 2 or 3
• patients undergoing an upper-limb surgery under regional anesthesia

You may not qualify if:

• regional anesthesia failure
• local anesthetics intoxications
• symptoms of cyber-sickness

Sponsors & Collaborators

• University Hospital, Mahdia: lead

Study Sites (1)

Taher Sfar University Hospital

Mahdia, 5111, Tunisia

Location

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Majdoub Ali MD, professor

  University Hospital, Mahdia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical professor

Model Details: 2 arms are involved in the study . first arm will receive local anesthesia with virtual reality during the surgery to reduce patient's anxiety . second arm will receive standards care under regional anesthesia

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 29, 2023
• Study Start: March 1, 2023
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)