Cutaneous LeishmaniasisNCT07858357
Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
A study testing Virtual Reality in people with Cutaneous Leishmaniasis and Pain, run by Stanford University.
Trial summary
The goal of this clinical trial is to learn whether immersive technology (virtual reality) headsets can reduce procedural pain and anxiety during diagnosis, intralesional and intramuscular injections, and wound/dressing care in pediatric patients 5 years of age and older and adult patients with cutaneous leishmaniasis… Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Cutaneous Leishmaniasis, Pain, Anxiety
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric cutaneous leishmaniasis patients
- Receiving cutaneous leishmaniasis care (diagnosis, treatment, and/or wound/lesion management) at the MSF cutaneous leishmaniasis facility in Peshawar
Who cannot join
- Legal guardian not present to obtain consent
- Child with a significant neurological condition, or major developmental disability
- A history of severe motion sickness
- A history of seizures cause by flashing light
- Major surgery within the last 48 hours
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn whether immersive technology (virtual reality) headsets can reduce procedural pain and anxiety during diagnosis, intralesional and intramuscular injections, and wound/dressing care in pediatric patients 5 years of age and older and adult patients with cutaneous leishmaniasis receiving treatment at the MSF clinic in Peshawar, Khyber Pakhtunkhwa, Pakistan.
- Conditions
- Cutaneous Leishmaniasis, Pain, Anxiety
- Being tested
- Virtual Reality
- Keywords
- Immersive Technology
- Medical subject headings
- Leishmaniasis, Cutaneous, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Participants interact with virtual reality games designed for procedural distraction while receiving medical treatment. Following treatment completion, participants undergo brief surveys and a semi-structured interview.
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous leishmaniasis (CL) patient | Experimental | Not described Receives: Behavioral: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant feasibility and acceptability regarding immersive technology
Qualitative evaluation of participant attitudes, perceptions, and user experience with immersive technology headsets collected via semi-structured focus group interviews. Feedback will be categorized into core thematic domains including ease of use, comfort, and willingness to use in future care.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858357
- Sponsor's protocol ID
- MSF01
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
- ClinicalTrials.gov ID
- NCT07858357
- Acronym / sponsor ID
- MSF01
- Conditions
- Cutaneous Leishmaniasis, Pain, Anxiety
- Keywords
- Immersive Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2026 (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 learn whether immersive technology (virtual reality) headsets can reduce procedural pain and anxiety during diagnosis, intralesional and intramuscular injections, and wound/dressing care in pediatric patients 5 years of age and older and adult patients with cutaneous leishmaniasis receiving treatment at the MSF clinic in Peshawar, Khyber Pakhtunkhwa, Pakistan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cutaneous leishmaniasis (CL) patient | Experimental | Behavioral: Virtual Reality |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pediatric cutaneous leishmaniasis patients
- Receiving cutaneous leishmaniasis care (diagnosis, treatment, and/or wound/lesion management) at the MSF cutaneous leishmaniasis facility in Peshawar
Key exclusion criteria (5 listed)
- Legal guardian not present to obtain consent
- Child with a significant neurological condition, or major developmental disability
- A history of severe motion sickness
- A history of seizures cause by flashing light
- Major surgery within the last 48 hours
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 RealityParticipants interact with virtual reality games designed for procedural distraction while receiving medical treatment. Following treatment completion, participants undergo brief surveys and a semi-structured interview. | Behavioural | Cutaneous leishmaniasis (CL) patient |
Primary outcome
Participant feasibility and acceptability regarding immersive technology
Time frame: Immediately after intervention
Qualitative evaluation of participant attitudes, perceptions, and user experience with immersive technology headsets collected via semi-structured focus group interviews. Feedback will be categorized into core thematic domains including ease of use, comfort, and willingness to use in future care.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Cutaneous Leishmaniasis and Pain, run by Stanford University.
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 2 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Caruso, MD, PhD (6507235728, tjcaruso@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant feasibility and acceptability regarding immersive technology (time frame: Immediately after intervention). 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 5 Oct 2026.