Sinus DiseaseNCT06812676
Virtual Reality Induced Analgesia for Nasal Procedures
A study testing Virtual Reality Goggles in people with Sinus Disease and Rhinitis, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
In-office nasal procedures can cause pain and discomfort to otolaryngology patients. While local anesthesia is the mainstay choice for main management, patients may have allergies or contraindications to the anesthetic agents used. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sinus Disease, Rhinitis, Turbinate; Hypertrophy Mucous Membrane
- What is being tested?
- Virtual Reality Goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Jul 2024to 3 Dec 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18-70 years old.
- Both genders.
- Scheduled for a nasal procedure using a 0-degree nasal endoscope.
- Procedure performed by consultant-level rhinologists blinded to the study group assignment (VR or control group).
Who cannot join
- History of significant nasal pathology (e.g. ciliary dyskinesia).
- Pregnancy or breastfeeding.
- Known neurological conditions that may affect pain perception or reported history of low pain threshold.
- Inability to understand or follow study procedures due to language barrier or cognitive impairment.
- Pre-existing psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital and Research center
Riyadh, 11211
About this study
In-office nasal procedures can cause pain and discomfort to otolaryngology patients. While local anesthesia is the mainstay choice for main management, patients may have allergies or contraindications to the anesthetic agents used. Moreover, some procedures may not require it, or patients may benefit from additional pain management techniques. The immersive experience of Virtual Reality (VR) could benefit those patients by utilizing visual stimuli to reduce pain perception in the body. This study aims to investigate the efficacy of VR for pain management, and to assess the overall satisfaction of patients. If proven effective, VR could provide a safe non-pharmacological treatment for reducing pain and improving comfort of patients, thus raising the quality of care in otolaryngology clinic.
Read the detailed description
Otolaryngology patients undergo routine office-based procedures such as nasal endoscopy, which may trigger distress, pain, and anxiety (1). This anxiety can, in turn, further exacerbate patients' perception of pain, which may require medication to alleviate. Minimizing unnecessary pharmacotherapy and reducing the risks associated with the side effects of pharmacologic treatments are of utmost importance. In addition, due to the ongoing opioid crisis, there is an urgency to identify effective non-pharmacological modalities for pain management across all patient populations. Distraction is a behavior management method used during procedures that may be painful or uncomfortable (2). The rationale is to reduce a patient's attention from cultivating pain signals and to thus diminish the pain experience (3).
In recent years, virtual reality (VR) has emerged as a potential analgesic and anxiolytic for medical procedures in both adult and pediatric populations (1). Virtual reality (VR) is an interactive computer-generated experience using a head-mounted display, which creates an immersive experience through visual and sound effects and enables dynamic interaction of the user in a virtual environment (2). Distraction using VR has been shown to be an effective intervention for reducing pain in children undergoing needle-related medical procedures (4). Amongst children and adolescents with kidney disease, significantly reduced pain intensity was reported during venipuncture amongst those who used VR compared to those who did not (5,6).
A randomized-control trial study conducted on pediatric orthopedics patients during out-patient procedures, Peter et al. concluded that During in-office cast and pin removal in pediatric patients, simple distraction techniques such as tablet video viewing are as effective as higher-fidelity VR headset video and interactive games in minimizing objective measures of procedural pain and subjective measures of pain and anxiety (8). On the other hand, in a study conducted on adult patients during bone marrow aspiration and biopsy procedures, Glennon et al found that More than half (51%) of the study participants reported some amount of anxiety reduction after the bone marrow aspiration and biopsy procedure, based on their reported anxiety score prior to the procedure (9). However, there is a clear lack in literature on using VR headsets in a wider patient cohort, where both adult and pediatric patients are involved.
Furthermore, in the field of otolaryngology, a randomized-control trial conducted on pediatric otolaryngology patients during nasal endoscopies, liu et al. found that VR intervention was associated with significantly reduced pain, significantly increased procedural satisfaction for patients, and significantly reduced anxiety levels for both patients and their caregivers (7). However, in addition to the study being limited to the pediatric age group, the study was also limited in terms of in-office procedures included. Therefore, further studies are warranted to apply the use of VR as an analgesic and anxiolytic to additional pediatric otolaryngology procedures in the office and peri-operative settings, as well as applying VR to additional age groups.
A randomized crossover trial was conducted on 82 adult patients who required office-based postoperative nasal endoscopy and debridement following functional endoscopic sinus surgery (FESS). Patients received either standard topical analgesia or VR treatment during nasal endoscopy and debridement, with outcomes measured using visual analog scales (VAS) for pain, Subjective Units of Distress Scale (SUDS) for anxiety, procedural time, reflexive head movements, and patient satisfaction scores. Results showed that VR treatment significantly decreased anxiety levels and reflexive head movements compared to standard treatment at the first postoperative visit. However, there were no significant differences in pain levels or procedural satisfaction between the two groups. At the second postoperative visit, patients who initially received standard treatment and later underwent VR treatment experienced reductions in pain, anxiety, reflexive head movements, and procedural time, while those who received VR treatment first showed no significant changes in pain or anxiety levels (10). Nonetheless, there are some limitations of the study, including potential bias due to lack of blinding, the relatively small sample size, and the restriction to adult patients undergoing postoperative sinonasal debridement in an outpatient setting. Thus, results regarding VR efficacy may not be generalizable to other procedures, settings, or patient populations.
In a randomized clinical trial conducted by Pandrangi et al. aimed at evaluating the efficacy of virtual reality (VR) in postoperative pain management following head and neck surgery, 30 hospitalized patients experiencing moderate to severe pain were enrolled. Patients were randomly allocated to receive either a 15-minute interactive VR gaming session using a headset or a similar gaming experience on a handheld smartphone device (control group). Pain scores were assessed before and after the intervention, alongside monitoring of opioid use. The findings revealed notable reductions in post-intervention pain among patients in the VR group immediately after the intervention and persisting for up to 3 hours afterward. Additionally, patients in the VR group displayed decreased opioid use for up to 8 hours post-intervention. Patient satisfaction with the VR intervention was high, indicating its potential as a non-pharmacologic adjunct for postoperative pain management after head and neck surgery (11).
The integration of virtual reality (VR) technology holds significant promise as a non-pharmacological method for managing pain and reducing anxiety in otolaryngology care. While existing research demonstrates overall favorable outcomes, it is often limited by small sample sizes, narrow age demographics, and specific otolaryngology interventions. Therefore, high-quality comprehensive studies involving larger sample sizes, diverse age groups and a wider array of otolaryngological interventions is warranted to establish the efficacy and feasibility of VR interventions in otolaryngology practice. This randomized controlled trial aims to contribute to this knowledge gap by investigating the impact of VR head-mounted displays on patient experiences, pain levels, and cooperation during procedures conducted at otolaryngology clinics.
- Conditions
- Sinus Disease, Rhinitis, Turbinate; Hypertrophy Mucous Membrane, Deviated Nasal Septum Acquired, Deviated Nasal Septum - Congenital
- Being tested
- Virtual Reality Goggles
- Keywords
- Virtual Reality, Nasal Procedures, Nasal Endoscopy, Otolaryngology, Pain Management, Non-pharmacological Intervention, Quality of Care
- Medical subject headings
- Paranasal Sinus Diseases, Rhinitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GogglesDevice
The VR group will be given a VR headset to wear during the nasal endoscopic procedure at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| VR Arm | Experimental | The VR group will wear the VR Receives: Device: Virtual Reality Goggles |
| Standard of care Arm | No intervention | patients will receive the standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain improvement
VR arm will experience less pain. VR could provide a safe non-pharmacological treatment for reducing pain and improving comfort of patients, thus raising the quality of care in otolaryngology clinics, Pain scores will be measured using the Numeric Rating Pain
Measured: Immediately upon rhinoscopy
Secondary outcomes (2)
Patient satisfaction
Patient satisfaction to be measured using a 5-point Linkert scale. VR could provide a safe non-pharmacological treatment for improving comfort of patients, thus raising the quality of care in otolaryngology clinics, 1. Patient satisfaction to be measured using a 5-point Linkert scale
Measured: Immediately upon rhinoscopy
patient willingness to use VR in future procedures
- Patient willingness to use VR in future procedures to be measured using a 5-point Linkert scale. VR could provide a safe non-pharmacological treatment for improving comfort of patients, thus raising the quality of care in otolaryngology clinics, 2. Patient willingness to use VR in future procedures to be measured using a
Measured: Immediately upon rhinoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start17 Jul 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients will be given a VR headset to wear during the nasal endoscopic procedure at the clinic.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812676
- Sponsor's protocol ID
- Virtual Reality
- Status last verified
- Dec 2024
- First submitted
- 2 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Induced Analgesia for Nasal Procedures
- ClinicalTrials.gov ID
- NCT06812676
- Acronym / sponsor ID
- Virtual Reality
- Conditions
- Sinus Disease, Rhinitis, Turbinate; Hypertrophy Mucous Membrane, Deviated Nasal Septum Acquired, Deviated Nasal Septum - Congenital
- Keywords
- Virtual Reality, Nasal Procedures, Nasal Endoscopy, Otolaryngology, Pain Management, Non-pharmacological Intervention, Quality of Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 6 Feb 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.
In-office nasal procedures can cause pain and discomfort to otolaryngology patients. While local anesthesia is the mainstay choice for main management, patients may have allergies or contraindications to the anesthetic agents used. Moreover, some procedures may not require it, or patients may benefit from additional pain management techniques. The immersive experience of Virtual Reality (VR) could benefit those patients by utilizing visual stimuli to reduce pain perception in the body. This study aims to investigate the efficacy of VR for pain management, and to assess the overall satisfaction of patients. If proven effective, VR could provide a safe non-pharmacological treatment for reducing pain and improving comfort of patients, thus raising the quality of care in otolaryngology clinic.
Detailed description
Otolaryngology patients undergo routine office-based procedures such as nasal endoscopy, which may trigger distress, pain, and anxiety (1). This anxiety can, in turn, further exacerbate patients' perception of pain, which may require medication to alleviate. Minimizing unnecessary pharmacotherapy and reducing the risks associated with the side effects of pharmacologic treatments are of utmost importance. In addition, due to the ongoing opioid crisis, there is an urgency to identify effective non-pharmacological modalities for pain management across all patient populations. Distraction is a behavior management method used during procedures that may be painful or uncomfortable (2). The rationale is to reduce a patient's attention from cultivating pain signals and to thus diminish the pain experience (3).
In recent years, virtual reality (VR) has emerged as a potential analgesic and anxiolytic for medical procedures in both adult and pediatric populations (1). Virtual reality (VR) is an interactive computer-generated experience using a head-mounted display, which creates an immersive experience through visual and sound effects and enables dynamic interaction of the user in a virtual environment (2). Distraction using VR has been shown to be an effective intervention for reducing pain in children undergoing needle-related medical procedures (4). Amongst children and adolescents with kidney disease, significantly reduced pain intensity was reported during venipuncture amongst those who used VR compared to those who did not (5,6).
A randomized-control trial study conducted on pediatric orthopedics patients during out-patient procedures, Peter et al. concluded that During in-office cast and pin removal in pediatric patients, simple distraction techniques such as tablet video viewing are as effective as higher-fidelity VR headset video and interactive games in minimizing objective measures of procedural pain and subjective measures of pain and anxiety (8). On the other hand, in a study conducted on adult patients during bone marrow aspiration and biopsy procedures, Glennon et al found that More than half (51%) of the study participants reported some amount of anxiety reduction after the bone marrow aspiration and biopsy procedure, based on their reported anxiety score prior to the procedure (9). However, there is a clear lack in literature on using VR headsets in a wider patient cohort, where both adult and pediatric patients are involved.
Furthermore, in the field of otolaryngology, a randomized-control trial conducted on pediatric otolaryngology patients during nasal endoscopies, liu et al. found that VR intervention was associated with significantly reduced pain, significantly increased procedural satisfaction for patients, and significantly reduced anxiety levels for both patients and their caregivers (7). However, in addition to the study being limited to the pediatric age group, the study was also limited in terms of in-office procedures included. Therefore, further studies are warranted to apply the use of VR as an analgesic and anxiolytic to additional pediatric otolaryngology procedures in the office and peri-operative settings, as well as applying VR to additional age groups.
A randomized crossover trial was conducted on 82 adult patients who required office-based postoperative nasal endoscopy and debridement following functional endoscopic sinus surgery (FESS). Patients received either standard topical analgesia or VR treatment during nasal endoscopy and debridement, with outcomes measured using visual analog scales (VAS) for pain, Subjective Units of Distress Scale (SUDS) for anxiety, procedural time, reflexive head movements, and patient satisfaction scores. Results showed that VR treatment significantly decreased anxiety levels and reflexive head movements compared to standard treatment at the first postoperative visit. However, there were no significant differences in pain levels or procedural satisfaction between the two groups. At the second postoperative visit, patients who initially received standard treatment and later underwent VR treatment experienced reductions in pain, anxiety, reflexive head movements, and procedural time, while those who received VR treatment first showed no significant changes in pain or anxiety levels (10). Nonetheless, there are some limitations of the study, including potential bias due to lack of blinding, the relatively small sample size, and the restriction to adult patients undergoing postoperative sinonasal debridement in an outpatient setting. Thus, results regarding VR efficacy may not be generalizable to other procedures, settings, or patient populations.
In a randomized clinical trial conducted by Pandrangi et al. aimed at evaluating the efficacy of virtual reality (VR) in postoperative pain management following head and neck surgery, 30 hospitalized patients experiencing moderate to severe pain were enrolled. Patients were randomly allocated to receive either a 15-minute interactive VR gaming session using a headset or a similar gaming experience on a handheld smartphone device (control group). Pain scores were assessed before and after the intervention, alongside monitoring of opioid use. The findings revealed notable reductions in post-intervention pain among patients in the VR group immediately after the intervention and persisting for up to 3 hours afterward. Additionally, patients in the VR group displayed decreased opioid use for up to 8 hours post-intervention. Patient satisfaction with the VR intervention was high, indicating its potential as a non-pharmacologic adjunct for postoperative pain management after head and neck surgery (11).
The integration of virtual reality (VR) technology holds significant promise as a non-pharmacological method for managing pain and reducing anxiety in otolaryngology care. While existing research demonstrates overall favorable outcomes, it is often limited by small sample sizes, narrow age demographics, and specific otolaryngology interventions. Therefore, high-quality comprehensive studies involving larger sample sizes, diverse age groups and a wider array of otolaryngological interventions is warranted to establish the efficacy and feasibility of VR interventions in otolaryngology practice. This randomized controlled trial aims to contribute to this knowledge gap by investigating the impact of VR head-mounted displays on patient experiences, pain levels, and cooperation during procedures conducted at otolaryngology clinics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled patients will be given a VR headset to wear during the nasal endoscopic procedure at the clinic.
| Arm | Type | Receives |
|---|---|---|
| VR Arm | Experimental | Device: Virtual Reality GogglesThe VR group will wear the VR |
| Standard of care Arm | No intervention | –patients will receive the standard of care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged between 18-70 years old.
- Both genders.
- Scheduled for a nasal procedure using a 0-degree nasal endoscope.
- Procedure performed by consultant-level rhinologists blinded to the study group assignment (VR or control group).
Key exclusion criteria (5 listed)
- History of significant nasal pathology (e.g. ciliary dyskinesia).
- Pregnancy or breastfeeding.
- Known neurological conditions that may affect pain perception or reported history of low pain threshold.
- Inability to understand or follow study procedures due to language barrier or cognitive impairment.
- Pre-existing psychiatric disorders.
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 GogglesThe VR group will be given a VR headset to wear during the nasal endoscopic procedure at the clinic. | Device | VR Arm |
Primary outcome
Pain improvement
Time frame: Immediately upon rhinoscopy
VR arm will experience less pain. VR could provide a safe non-pharmacological treatment for reducing pain and improving comfort of patients, thus raising the quality of care in otolaryngology clinics, Pain scores will be measured using the Numeric Rating Pain
2 secondary outcomes
Patient satisfaction
Time frame: Immediately upon rhinoscopy
patient willingness to use VR in future procedures
Time frame: Immediately upon rhinoscopy
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 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Goggles in people with Sinus Disease and Rhinitis, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 4 inclusion and 5 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 6 Feb 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 Saudi Arabia. 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?
Pain improvement (time frame: Immediately upon rhinoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.