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

Primary Purpose

Anxiety, Satisfaction, Patient

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
a virtual reality device
Sponsored by
University Hospital, Mahdia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring virtual reality, anxiety, patient satisfaction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: patient classified ASA 1 , 2 or 3 patients undergoing an upper-limb surgery under regional anesthesia Exclusion Criteria: regional anesthesia failure local anesthetics intoxications symptoms of cyber-sickness

Sites / Locations

  • Taher Sfar University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

group of patients who underwent surgery with the virtual reality experience

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

Arm Description

patients underwent surgery wearing a virtual reality mask

patients underwent surgery without a virtual reality mask

Outcomes

Primary Outcome Measures

hypnovel consumption during surgery
the required dose of Midazolam for a LIKERT intraoperative anxiety score goal < 2

Secondary Outcome Measures

satisfaction level during surgery
satisfaction levels measured with a LIKERT scale : 1 : not satisfied , 2: low satisfaction , 3:satisfied , 4: great satisfaction
pre-operative patients's anxiety level by LIKERT score
pre operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
per-operative patients's anxiety level by LIKERT score
per operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
post-operative patients's anxiety level by LIKERT score
post operative anxiety measured with a LIKERT scale: 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
vitals : systolic pressure
vitals were monitored all long the procedure
vitals : heart rate
vitals were monitored all long the procedure
vitals : oxygen saturation
vitals were monitored all long the procedure
pre-operative patients's anxiety level by STAI-6 score
pre operative anxiety measured with a STAI-6 modified scale : a total score superior to 65 : high anxiety , score between 56-65 : too high anxiety , score between : 36 - 45 : low anxiety , score inferior to 35 no anxiety
post-operative patients's anxiety level by STAI-6 score
post operative anxiety measured with a STAI-6 modified scale : a total score superior to 65 : high anxiety , score between 56-65 : too high anxiety , score between : 36 - 45 : low anxiety , score inferior to 35 no anxiety

Full Information

First Posted
August 25, 2023
Last Updated
September 24, 2023
Sponsor
University Hospital, Mahdia
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1. Study Identification

Unique Protocol Identification Number
NCT06061198
Brief Title
Impact of Virtual Reality on Patient's Anxiety Who Underwent Surgery Uner Regional Anesthesia
Acronym
VRanxiety
Official Title
Impact of Virtual Reality on Patient's Anxiety During Upper Limb Surgery Under Regional Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
May 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Mahdia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
patients who had surgery with the virtual reality experience or the VR- group ( group of patients who had surgery with standard measures without virtual reality) The patient was setup comfortably on the operating table.The echo-guided regional anesthesia appropriate to the surgical procedure is performed by an experienced anesthesiologist.In the RV+ patients, loco regional anesthesia was performed before installing the VR mask and before initiating immersing in the virtual reality space. anesthesia protocol was performed before initiating VR experience to maintain audiovisual and cognitive contact with the patient and detect possible complications For the virtual reality immersion for the VR+ group, we used an OCULUS SAMSUNG GEAR VR, a virtual reality headset connected to a SAMSUNG S7 Edge phone with headphones.The headset was worn after the loco regional anesthesia and removed at the end of the procedure.The helmet is adapted to each patient according to his head circumference measurements and the image adjustment is personalized.The VR session consists of an immersion in a natural relaxation environment produced by an application downloaded from the OCULUS STORE: VR Guided Meditation.The application offers a choice of 4 environments: Relaxing day on a tropical beach, beautiful sunset beach, mountain sunrise, or forest nap experiences . The choice of the environment is randomized according to the patient's preferences.For patients who belongs to the VR- group, the procedure was performed under standard conditions with a drape separating the patient from the operating site During surgery, the vital signs: HR, PANI, SpO2 were collected at the different peri-operative moments respectively at the entrance to the operating room (T0), 15 minutes after ALR (T1), 30 minutes after ALR (T2), 30 minutes (T3), 1 hour (T4) and 2 hours (T5) An intraoperative assessment of anxiety was performed after 15 minutes of ALR, i.e. at T1 by the LIKERT scale The anesthesist could administer anxiolytics outside of the contraindications. The molecule of choice is Midazolam and the dose taken is noted on the data collection form The administration of anxiolytics (Midazolam) is judged by clinical criteria determined in the protocol:- Anxiety during the operation judged as painful or important (higher than2 on the LIKERT scale) The session can be interrupted during the procedure for medical reasons or at the patient's request.If the local anesthesia fails and the patient is converted to general anesthesia, the protocol is cancelled and a standard induction is performed by the anesthesiologist.The events of desaturation (SpO2 < 90%), apnea, administration of anxiolytics administration of anxiolytics (to reach a minimal level of anxiety) were indicated on the data collection form.For both RV+ and RV- groups, postoperative anxiety was assessed using the scores:1- Postoperative STAI at H1 postoperative2- patient satisfaction evaluated by a LIKERT scale

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Satisfaction, Patient
Keywords
virtual reality, anxiety, patient satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group of patients who underwent surgery with the virtual reality experience
Arm Type
Active Comparator
Arm Description
patients underwent surgery wearing a virtual reality mask
Arm Title
patients who underwent surgery in standard conditions without the virtual reality experience
Arm Type
No Intervention
Arm Description
patients underwent surgery without a virtual reality mask
Intervention Type
Device
Intervention Name(s)
a virtual reality device
Intervention Description
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
Primary Outcome Measure Information:
Title
hypnovel consumption during surgery
Description
the required dose of Midazolam for a LIKERT intraoperative anxiety score goal < 2
Time Frame
From enrollment to the end of treatment at 10 weeks
Secondary Outcome Measure Information:
Title
satisfaction level during surgery
Description
satisfaction levels measured with a LIKERT scale : 1 : not satisfied , 2: low satisfaction , 3:satisfied , 4: great satisfaction
Time Frame
at the end of the procedure
Title
pre-operative patients's anxiety level by LIKERT score
Description
pre operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Time Frame
From enrollment to the end of treatment at 10 weeks
Title
per-operative patients's anxiety level by LIKERT score
Description
per operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Time Frame
From enrollment to the end of treatment at 10 weeks
Title
post-operative patients's anxiety level by LIKERT score
Description
post operative anxiety measured with a LIKERT scale: 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Time Frame
From enrollment to the end of treatment at 10 weeks
Title
vitals : systolic pressure
Description
vitals were monitored all long the procedure
Time Frame
From enrollment to the end of treatment at 10 weeks
Title
vitals : heart rate
Description
vitals were monitored all long the procedure
Time Frame
From enrollment to the end of treatment at 10 weeks
Title
vitals : oxygen saturation
Description
vitals were monitored all long the procedure
Time Frame
From enrollment to the end of treatment at 10 weeks
Title
pre-operative patients's anxiety level by STAI-6 score
Description
pre operative anxiety measured with a STAI-6 modified scale : a total score superior to 65 : high anxiety , score between 56-65 : too high anxiety , score between : 36 - 45 : low anxiety , score inferior to 35 no anxiety
Time Frame
From enrollment to the end of treatment at 10 weeks
Title
post-operative patients's anxiety level by STAI-6 score
Description
post operative anxiety measured with a STAI-6 modified scale : a total score superior to 65 : high anxiety , score between 56-65 : too high anxiety , score between : 36 - 45 : low anxiety , score inferior to 35 no anxiety
Time Frame
From enrollment to the end of treatment at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patient classified ASA 1 , 2 or 3 patients undergoing an upper-limb surgery under regional anesthesia Exclusion Criteria: regional anesthesia failure local anesthetics intoxications symptoms of cyber-sickness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majdoub Ali MD, professor
Organizational Affiliation
University Hospital, Mahdia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taher Sfar University Hospital
City
Mahdia
ZIP/Postal Code
5111
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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