Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT03999333
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of chronic biliary type abdominal pain (RUQ pain, pain radiates to the right flank, scapula, or shoulder, or pain that stimulates gallbladder symptoms)
* Pancreatic pain (epigastric or left upper quadrant pain, pain that is exacerbated by some food, or pain that radiates to the back) for at least 3 months prior to the study
* absence of abnormal liver and pancreas chemistry or abnormal abdominal imaging
* average pain score of greater than or equal to 3 out of 10 on the numeric rating scale (NRS) for at least the average of 3 episodes each week
* Subjects on antidepressants for pain control should take the medication for a minimum of one month prior to the baseline assessment.
* Patients with SOD with depressive and/or anxiety disorders who receive psychopharmacologic treatment must be on stable medication dose for at least 6 weeks.
* Patients with access to a cell phone, able to speak, read, and write English will be enrolled.
Exclusion Criteria:
* Patients with evidence for acute or chronic pancreatitis, biliary stones, or bile duct strictures.
* Patients who have had prior sphincterotomy must have had the procedure at 3 months prior to the start of the study.
* Patients with a history of motion sickness and vertigo and anyone experiencing active nausea or vomiting (including pregnant women) will be excluded.
* Patients with a history of seizures or epilepsy will also be excluded to limit the theoretical risk of inducing seizures with VR.
* Presence of significant psychiatric disorders or any conditions that, in the investigator's opinion make the subject unsuitable for study participation will be reason for exclusion.
* Non-English speaking subjects or subjects unable to consent to study due to cognitive difficulty will not be included in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03999333
Study Brief:
Protocol Section:
NCT03999333