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The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental VR |
|
| Sham | Sham Comparator | Sham VR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | Virtual reality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal pain scores | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for abdominal pain. Scored 0-5, with higher scores representing more severe symptoms. | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall PAGI-SYM scores | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire. All symptoms scored 0-5, with higher scores representing more severe symptoms. A total PAGI-SYM score is determined by calculating the average of all symptom scores | Baseline, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cangemi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Change in nausea/vomiting |
Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for nausea/vomiting. Scored 0-5, with higher scores representing more severe symptoms. |
| Baseline, 8 weeks |
| Change in bloating | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for bloating. Scored 0-5, with higher scores representing more severe symptoms. | Baseline, 8 weeks |
| Change in post-prandial fullness | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for early satiety/postprandial fullness. Scored 0-5, with higher scores representing more severe symptoms. | Baseline, 8 weeks |
| Change in heartburn | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for heartburn. Scored 0-5, with higher scores representing more severe symptoms. | Baseline, 8 weeks |