Gastrointestinal DiseasesNCT06262126
Virtual Reality for Non-cardiac Chest Pain
A study testing Virtual Reality in people with Gastrointestinal Diseases and Chest Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Chest Pain
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain)
- Negative prior cardiac evaluation (at a minimum, including electrocardiogram)
- Prior esophagogastroduodenoscopy and/or barium esophagram to rule out severe esophagitis, stricture, or motility abnormality
Who cannot join
- Initiation of a proton pump inhibitor (PPI) within 8 weeks
- Major concomitant illness
- Current drug or alcohol use that that would interfere with adherence to study requirements
- Symptoms of vertigo or dizziness that would limit tolerability of the VR headset
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Wendi Lehman, 904-953-8742, Lehman.Wendi@mayo.edu
About this study
Official title: A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain
The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).
Read the detailed description
The primary aim of this study is to assess the overall feasibility of virtual reality for the treatment of noncardiac chest pain and identify problems, issues, or challenges that may impact the performance of a future clinical trial. As such, the study will focus on willingness to participate, patient adherence, patient retention, and burdensomeness of the intervention and survey instruments. As a lesser objective, we will assess the effectiveness of virtual reality in patients with noncardiac chest pain at improving pain severity, symptom hypervigilance, anxiety, quality of life, and resilience.
- Conditions
- Gastrointestinal Diseases, Chest Pain
- Being tested
- Virtual Reality
- Keywords
- Virtual reality
- Medical subject headings
- Gastrointestinal Diseases, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Virtual Reality therapy
| Study group | Role | What they receive |
|---|---|---|
| VR Arm | Other | Viritual Reality therapy arm. All patients will receive virtual reality therapy. Receives: Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure changes in GERD symptoms using the GERDQ questionnare
Gastroesophageal reflux disease (GERD) questionnaire (GerdQ) is a 6-item questionnaire (scale from 0 to 18) that measures heartburn, regurgitation, abdominal pain, nausea, sleep disorders, and the over-the-counter (OTC) drugs use. The score predicts the likelihood of GERD, with a score between 11-18 suggesting 89% or greater likelihood.
Measured: Week 2
Measure changes in GERD quality of life using the GERD-HRQL questionnaire
GERD-HRQL- Gastroesophageal reflux disease (GERD) - Health Related Quality of Life (HRQL) The scale has 15 items, which focus on heartburn symptoms, dysphagia, medication effects and health condition. Each item is scored from 0 to 5 (maximum score 75), with a higher score indicating a better QOL
Measured: Week 2
Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire
The esophageal hypervigilance and anxiety scale (EHAS) The EHAS is a 15-item measure with two factors evaluating esophageal hypervigilance and symptom specific anxiety scored on a 0-4 Likert scale. Items are summed to yield a total score ranging from 0 - 60 (Greater hypervigilance/anxiety).
Measured: Week 2
Measure changes in GI symptom severity using the PAGI-SYM questionnaire
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) The PAGI-SYM includes 6 subscales ranging from 0 (none) to 5 (very severe): heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain.
Measured: Week 2
Measure changes in GI related patient assessment of quality of life using PAGI-QOL
Patient Assessment of Gastrointestinal Disorders-Quality of Life (PAGI-QOL) The PAGI-QOL Is an instrument scoring 30 factors each from 0 (none of the time) to 5 (all of the time). Symptoms are assessed over a 2 week period and include the 5 domains daily activities, clothing, diet and food habits, psychological well-being/distress, and relationships.
Measured: Week 2
Secondary outcomes (2)
Measure changes in anxiety and depression using the HADs scale
The Hospital Anxiety and Depression Scale (HADs) consists of 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'.
Measured: Week 2
Measure changes in resilience using the brief resilience scale
The brief resilience scale is a 6 question survey assessing resiliency with questions assessed by a 5 point Likert scale.
12-item short form survey (SF-12). The SF-12 is a 12 question survey assessing the impact of health on a patient's everyday life. The questions assess 8 domains including physical activities, social activities, pain, mental health, vitality, general health perceptions and limitations related to physical and emotional problems.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start14 Feb 2024
- 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 Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andree H. Koop, Mayo Clinic
- Investigators
- Andree Koop, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262126
- Sponsor's protocol ID
- 23-012673
- Status last verified
- Oct 2026
- First submitted
- 25 Jan 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain
- ClinicalTrials.gov ID
- NCT06262126
- Acronym / sponsor ID
- 23-012673
- Conditions
- Gastrointestinal Diseases, Chest Pain
- Keywords
- Virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Feb 2024 (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 purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).
Detailed description
The primary aim of this study is to assess the overall feasibility of virtual reality for the treatment of noncardiac chest pain and identify problems, issues, or challenges that may impact the performance of a future clinical trial. As such, the study will focus on willingness to participate, patient adherence, patient retention, and burdensomeness of the intervention and survey instruments. As a lesser objective, we will assess the effectiveness of virtual reality in patients with noncardiac chest pain at improving pain severity, symptom hypervigilance, anxiety, quality of life, and resilience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR Arm | Other | Other: Virtual RealityViritual Reality therapy arm. All patients will receive virtual reality therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain)
- Negative prior cardiac evaluation (at a minimum, including electrocardiogram)
- Prior esophagogastroduodenoscopy and/or barium esophagram to rule out severe esophagitis, stricture, or motility abnormality
Key exclusion criteria (4 listed)
- Initiation of a proton pump inhibitor (PPI) within 8 weeks
- Major concomitant illness
- Current drug or alcohol use that that would interfere with adherence to study requirements
- Symptoms of vertigo or dizziness that would limit tolerability of the VR headset
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 RealityVirtual Reality therapy | Other | VR Arm |
Primary outcome
Measure changes in GERD symptoms using the GERDQ questionnare
Time frame: Week 2
Gastroesophageal reflux disease (GERD) questionnaire (GerdQ) is a 6-item questionnaire (scale from 0 to 18) that measures heartburn, regurgitation, abdominal pain, nausea, sleep disorders, and the over-the-counter (OTC) drugs use. The score predicts the likelihood of GERD, with a score between 11-18 suggesting 89% or greater likelihood.
Measure changes in GERD quality of life using the GERD-HRQL questionnaire
Time frame: Week 2
GERD-HRQL- Gastroesophageal reflux disease (GERD) - Health Related Quality of Life (HRQL) The scale has 15 items, which focus on heartburn symptoms, dysphagia, medication effects and health condition. Each item is scored from 0 to 5 (maximum score 75), with a higher score indicating a better QOL
Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire
Time frame: Week 2
The esophageal hypervigilance and anxiety scale (EHAS) The EHAS is a 15-item measure with two factors evaluating esophageal hypervigilance and symptom specific anxiety scored on a 0-4 Likert scale. Items are summed to yield a total score ranging from 0 - 60 (Greater hypervigilance/anxiety).
Measure changes in GI symptom severity using the PAGI-SYM questionnaire
Time frame: Week 2
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) The PAGI-SYM includes 6 subscales ranging from 0 (none) to 5 (very severe): heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain.
Measure changes in GI related patient assessment of quality of life using PAGI-QOL
Time frame: Week 2
Patient Assessment of Gastrointestinal Disorders-Quality of Life (PAGI-QOL) The PAGI-QOL Is an instrument scoring 30 factors each from 0 (none of the time) to 5 (all of the time). Symptoms are assessed over a 2 week period and include the 5 domains daily activities, clothing, diet and food habits, psychological well-being/distress, and relationships.
2 secondary outcomes
Measure changes in anxiety and depression using the HADs scale
Time frame: Week 2
Measure changes in resilience using the brief resilience scale
Time frame: Week 2
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 3 Nov 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Andree Koop, MD principal investigator
Mayo Clinic
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 in people with Gastrointestinal Diseases and Chest Pain, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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 United States. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure changes in GERD symptoms using the GERDQ questionnare (time frame: Week 2). The study lists 5 primary outcomes in all. 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 3 Nov 2026.