Perioperative AnxietyNCT07134764
Evaluation of the Effectiveness of Virtual Reality as an Adjunct to Standard Care in Managing Perioperative Anxiety and Pain in Patients Undergoing Lower Limb Orthopedic Surgery Under Spinal Anesthesia
A study testing Virtual reality session in people with Perioperative Anxiety and Perioperative Pain Management, run by University of Sfax at 1 site in Tunisia.
Trial summary
The goal of this clinical trial is to evaluate whether virtual reality (VR) can effectively reduce perioperative anxiety and pain in patients undergoing lower limb orthopedic surgery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Anxiety, Perioperative Pain Management, Hemodynamic Stability
- What is being tested?
- Virtual reality session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Sep 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Inclusion Criteria :
- Age between 19 and 64 years
- American Society of Anesthesiologists (ASA) physical status classification I or II (Annex 1)
- Scheduled for lower limb orthopedic surgery under spinal anesthesia
- Provided informed consent to participate in the study
- Non-Inclusion Criteria :
Show all 11Show fewer
- Patient refusal to participate in the study
- Contraindications to virtual reality (VR) (Patients with cognitive or psychiatric disorders, Claustrophobia, Uncontrolled epilepsy, Visual and/or auditory impairments preventing the use of VR)
- Contraindications to midazolam: known hypersensitivity to benzodiazepines or any excipient of the product
- Patients currently taking anxiolytic medications
- Contraindications to regional anesthesia (spinal anesthesia), (Coagulation disorders, Shock or uncompensated hypovolemia, Unstable arterial hypertension, Decompensated heart failure, Severe aortic or mitral stenosis, Intracranial hypertension, Infection near the puncture site, Progressive neurological disorders, Allergy to local anesthetics, Technical difficulties in performing spinal anesthesia)
Who cannot join
- Failure of spinal anesthesia requiring conversion to general anesthesia
- Occurrence of an anesthetic or surgical complication
- Occurrence of an adverse effect related to virtual reality, such as (Dizziness, Ocular or muscular contractions triggered by light stimulation, Signs of discomfort : eye strain, blurred vision, disorientation, imbalance, anxiety attack, headache, nausea, vomiting)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate whether virtual reality (VR) can effectively reduce perioperative anxiety and pain in patients undergoing lower limb orthopedic surgery under spinal anesthesia. The study focuses on adult patients in a surgical setting, with an emphasis on improving intraoperative experience and postoperative outcomes without relying solely on pharmacological interventions.
The main questions it aims to answer are:
Read more
- Can VR reduce perioperative anxiety and perceived pain levels?
- Does the use of VR lower the need for sedative and analgesic medications and improve hemodynamic stability and satisfaction?
Researchers will compare a VR intervention group to a standard care group to see if VR leads to reduced anxiety and pain, less medication use, better physiological stability, and improved satisfaction.
Participants will:
- Undergo orthopedic surgery under spinal anesthesia.
- Be randomly assigned to either receive standard perioperative care or standard care plus VR immersion.
- In the VR group, engage in calming, immersive virtual environments during the perioperative period.
Read the detailed description
This randomized controlled clinical trial investigates the effect of immersive virtual reality (VR) on the management of perioperative anxiety and pain in patients undergoing elective lower limb orthopedic surgery under spinal anesthesia. The use of VR as a non-pharmacological adjunct is a novel and promising approach intended to improve the patient's perioperative experience, optimize physiological responses, and potentially reduce the consumption of sedatives and analgesics.
Participants in the intervention group will wear a VR headset that delivers immersive, calming visual and auditory content designed to promote relaxation and distraction before, during, and after the surgical procedure. The control group will receive standard care without VR. Both groups will receive spinal anesthesia as part of routine clinical practice.
Anxiety and pain will be measured at predefined perioperative time points using validated visual analog scales (VAS) and APAIS scale. Additional data on hemodynamic parameters, sedative and analgesic consumption, intraoperative complications, and postoperative satisfaction (from patients, surgeons, and anesthetists) will be collected to evaluate the overall impact of VR on perioperative care quality and patient outcomes.
This study is being conducted at Habib Bourguiba University Hospital, Sfax, Tunisia, over a 12-month period and represents the first clinical evaluation of virtual reality technology in an anesthesia context at this institution. The findings may contribute to the integration of digital tools into routine perioperative care, especially in low-resource settings, by demonstrating their utility in reducing stress, improving comfort, and supporting enhanced recovery after surgery.
- Conditions
- Perioperative Anxiety, Perioperative Pain Management, Hemodynamic Stability, Satisfaction, Sedative Consumption, Postoperative Complications
- Being tested
- Virtual reality session
- Keywords
- Virtual reality, Perioperative anxiety, Perioperative pain, Orthopedic surgery, Spinal anesthesia, Randomized controlled trial, Lower limb surgery, Hemodynamic stability
- Medical subject headings
- Personal Satisfaction, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality sessionDevice
Patients included in the intervention group (VR group) participated in a comprehensive virtual reality program designed to reduce perioperative anxiety and pain. Prior to their surgery, they attended an introductory VR session aimed at familiarizing them with the technology and providing a calming, immersive environment to help alleviate preoperative stress. Throughout their surgical journey, these patients continued to receive the usual standard care, which included thorough preoperative consultations with healthcare providers, detailed information about the planned surgical procedure, and the provision of standard postoperative care to support recovery. Additionally, during the surgery itself, patients underwent a VR session delivered via a headset, offering real-time immersive distraction and relaxation to minimize intraoperative anxiety and pain perception.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Participants in the experimental group will receive an immersive virtual reality (VR) session as an adjunct to standard perioperative care. A SHINECON VR headset will be used to deliver calming or distraction-based visual and auditory content during the entire duration of the orthopedic surgery under spinal anesthesia. The session aims to reduce anxiety and pain perception, minimize the need for sedatives and analgesics, enhance hemodynamic stability, and improve patient and healthcare team satisfaction. Receives: Device: Virtual reality session |
| T group | No intervention | Participants in the control group will receive standard perioperative care as per institutional protocol during orthopedic surgery under spinal anesthesia. No virtual reality device or additional non-pharmacological intervention will be administered. Anxiety, pain, hemodynamic stability, sedative and analgesic use, and satisfaction will be evaluated and compared to the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Immersive Virtual Reality on Reducing Perioperative Anxiety in Lower Limb Orthopedic Surgery Under Spinal Anesthesia
The inversigator expect that the use of immersive virtual reality (VR) during lower limb orthopedic surgery under spinal anesthesia will: Significantly reduce perioperative anxiety levels compared to standard care
Measured: pre during the intervention and post-intervention
Secondary outcomes (1)
The Effect of Virtual Reality on Perioperative Pain, Sedative Use, and Patient Satisfaction in Orthopedic Surgery Under Spinal Anesthesia
The investigator expect that the use of immersive virtual reality (VR) during lower limb orthopedic surgery under spinal anesthesia will:
- Lower the intensity of perioperative pain as measured by validated pain scales
- Decrease the need for sedative and analgesic medications during the perioperative period
- Contribute to more stable hemodynamic parameters during and after the procedure
- Increase overall satisfaction among patients, as well as anesthesia and surgical teams
Measured: pre during the intervention and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2024
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in parallel to one of two groups: the intervention group receiving virtual reality exposure during the perioperative period, or the control group receiving standard care. Each participant remains in their assigned group throughout the study, and outcomes will be compared between the two groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sfax
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fedi Ben Dhaou, University of Sfax
- Investigators
- Imen Zouche, Professor in Medicine, Study director, University of SfaxYosra Mejdoub, Professor in Medicine, Study director, University of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134764
- Sponsor's protocol ID
- FMS-24-11-1999-51-24
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Dhaou FB, Mejdoub Y, Trigui M, Mziou E, Ayedi A, Boussarsar M, Keskes M, Maktouf Y, Mezghani F, Regaieg MS, Bardaa T, Ben Dhaou CE, Cheikhrouhou H, Zouche I. Virtual Reality for Anxiety and Pain Management in Lower Limb Orthopedic Surgery Under Spinal Anesthesia: A Randomized Controlled Trial. Health Sci Rep. 2026 Sep 24;9(10):e73146. doi: 10.1002/hsr2.73146. eCollection 2026 Oct.
PubMed 42787594
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Virtual Reality as an Adjunct to Standard Care in Managing Perioperative Anxiety and Pain in Patients Undergoing Lower Limb Orthopedic Surgery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07134764
- Acronym / sponsor ID
- FMS-24-11-1999-51-24
- Conditions
- Perioperative Anxiety, Perioperative Pain Management, Hemodynamic Stability, Satisfaction, Sedative Consumption, Postoperative Complications
- Keywords
- Virtual reality, Perioperative anxiety, Perioperative pain, Orthopedic surgery, Spinal anesthesia, Randomized controlled trial, Lower limb surgery, Hemodynamic stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SfaxUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether virtual reality (VR) can effectively reduce perioperative anxiety and pain in patients undergoing lower limb orthopedic surgery under spinal anesthesia. The study focuses on adult patients in a surgical setting, with an emphasis on improving intraoperative experience and postoperative outcomes without relying solely on pharmacological interventions.
The main questions it aims to answer are:
- Can VR reduce perioperative anxiety and perceived pain levels?
- Does the use of VR lower the need for sedative and analgesic medications and improve hemodynamic stability and satisfaction?
Researchers will compare a VR intervention group to a standard care group to see if VR leads to reduced anxiety and pain, less medication use, better physiological stability, and improved satisfaction.
Participants will:
- Undergo orthopedic surgery under spinal anesthesia.
- Be randomly assigned to either receive standard perioperative care or standard care plus VR immersion.
- In the VR group, engage in calming, immersive virtual environments during the perioperative period.
Detailed description
This randomized controlled clinical trial investigates the effect of immersive virtual reality (VR) on the management of perioperative anxiety and pain in patients undergoing elective lower limb orthopedic surgery under spinal anesthesia. The use of VR as a non-pharmacological adjunct is a novel and promising approach intended to improve the patient's perioperative experience, optimize physiological responses, and potentially reduce the consumption of sedatives and analgesics.
Participants in the intervention group will wear a VR headset that delivers immersive, calming visual and auditory content designed to promote relaxation and distraction before, during, and after the surgical procedure. The control group will receive standard care without VR. Both groups will receive spinal anesthesia as part of routine clinical practice.
Anxiety and pain will be measured at predefined perioperative time points using validated visual analog scales (VAS) and APAIS scale. Additional data on hemodynamic parameters, sedative and analgesic consumption, intraoperative complications, and postoperative satisfaction (from patients, surgeons, and anesthetists) will be collected to evaluate the overall impact of VR on perioperative care quality and patient outcomes.
This study is being conducted at Habib Bourguiba University Hospital, Sfax, Tunisia, over a 12-month period and represents the first clinical evaluation of virtual reality technology in an anesthesia context at this institution. The findings may contribute to the integration of digital tools into routine perioperative care, especially in low-resource settings, by demonstrating their utility in reducing stress, improving comfort, and supporting enhanced recovery after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in parallel to one of two groups: the intervention group receiving virtual reality exposure during the perioperative period, or the control group receiving standard care. Each participant remains in their assigned group throughout the study, and outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Virtual reality sessionParticipants in the experimental group will receive an immersive virtual reality (VR) session as an adjunct to standard perioperative care. A SHINECON VR headset will be used to deliver calming or distraction-based visual and auditory content during the entire duration of the orthopedic surgery under spinal anesthesia. The session aims to reduce anxiety and pain perception, minimize the need for sedatives and analgesics, enhance hemodynamic stability, and improve patient and healthcare team satisfaction. |
| T group | No intervention | –Participants in the control group will receive standard perioperative care as per institutional protocol during orthopedic surgery under spinal anesthesia. No virtual reality device or additional non-pharmacological intervention will be administered. Anxiety, pain, hemodynamic stability, sedative and analgesic use, and satisfaction will be evaluated and compared to the experimental group. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- - Inclusion Criteria :
- Age between 19 and 64 years
- American Society of Anesthesiologists (ASA) physical status classification I or II (Annex 1)
- Scheduled for lower limb orthopedic surgery under spinal anesthesia
- Provided informed consent to participate in the study
Key exclusion criteria (3 listed)
- Failure of spinal anesthesia requiring conversion to general anesthesia
- Occurrence of an anesthetic or surgical complication
- Occurrence of an adverse effect related to virtual reality, such as (Dizziness, Ocular or muscular contractions triggered by light stimulation, Signs of discomfort : eye strain, blurred vision, disorientation, imbalance, anxiety attack, headache, nausea, vomiting)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality sessionPatients included in the intervention group (VR group) participated in a comprehensive virtual reality program designed to reduce perioperative anxiety and pain. Prior to their surgery, they attended an introductory VR session aimed at familiarizing them with the technology and providing a calming, immersive environment to help alleviate preoperative stress. Throughout their surgical journey, these patients continued to receive the usual standard care, which included thorough preoperative consultations with healthcare providers, detailed information about the planned surgical procedure, and the provision of standard postoperative care to support recovery. Additionally, during the surgery itself, patients underwent a VR session delivered via a headset, offering real-time immersive distraction and relaxation to minimize intraoperative anxiety and pain perception. | Device | VR group |
Primary outcome
Impact of Immersive Virtual Reality on Reducing Perioperative Anxiety in Lower Limb Orthopedic Surgery Under Spinal Anesthesia
Time frame: pre during the intervention and post-intervention
The inversigator expect that the use of immersive virtual reality (VR) during lower limb orthopedic surgery under spinal anesthesia will: Significantly reduce perioperative anxiety levels compared to standard care
1 secondary outcome
The Effect of Virtual Reality on Perioperative Pain, Sedative Use, and Patient Satisfaction in Orthopedic Surgery Under Spinal Anesthesia
Time frame: pre during the intervention and post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 42787594Dhaou FB, Mejdoub Y, Trigui M, Mziou E, Ayedi A, Boussarsar M, Keskes M, Maktouf Y, Mezghani F, Regaieg MS, Bardaa T, Ben Dhaou CE, Cheikhrouhou H, Zouche I. Virtual Reality for Anxiety and Pain Management in Lower Limb Orthopedic Surgery Under Spinal Anesthesia: A Randomized Controlled Trial. Health Sci Rep. 2026 Sep 24;9(10):e73146. doi: 10.1002/hsr2.73146. eCollection 2026 Oct.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imen Zouche, Professor in Medicine study director
University of Sfax
Yosra Mejdoub, Professor in Medicine study director
University of Sfax
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality session in people with Perioperative Anxiety and Perioperative Pain Management, run by University of Sfax at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Immersive Virtual Reality on Reducing Perioperative Anxiety in Lower Limb Orthopedic Surgery Under Spinal Anesthesia (time frame: pre during the intervention and post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07134764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.