A Pilot Study to Evaluate the Efficacy and Safety of Virtual Reality in Combination With Linaclotide for the Treatment of Adults With IBS and Constipation Predominance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Changes in IBS symptoms
研究概览
简要总结
The purpose of this study is to determine if adult patients with IBS-C will report an overall greater improvement in IBS symptoms and quality of life when treated with a combination of linaclotide (standard of care medication) and immersive virtual reality (VR) therapy compared to those treated with linaclotide and sham (placebo) VR therapy.
详细描述
The primary aim of this study will be to assess the benefits of disease-targeted VR combined with linaclotide, compared to sham VR combined with linaclotide, in patients with IBS-C as defined by Rome IV criteria. The investigators hypothesize that compared to patients receiving sham VR and linaclotide, IBS-C patients receiving combination therapy with active VR and linaclotide will achieve statistically significant and clinically meaningful improvements in disease-targeted health-related quality of life while demonstrating improvements in global IBS symptoms, including abdominal pain.
Aims
- Evaluate changes in quality of life using the validated IBS-QoL (primary outcome);
- Evaluate global improvement in IBS symptoms using the validated IBS-SSS;
- Assess global improvement in IBS symptoms using the validated Abdominal Scoring system (11);
- Evaluate improvement in abdominal pain using a numerical rating system (NRS);
- Assess improvement in constipation using the Bristol Stool Form Scale (BSFS);
- Evaluate response to bloating using the validated Mayo bloating questionnaire (12);
- Assess response to coexisting psychological distress using the validated HADs questionnaire;
- Evaluate changes in work productivity using the validated WPAI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The participant or their treating provider will not know if they have been assigned to the sham VR or immersive VR program.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women (18-70) who meet Rome IV criteria for IBS-C.
- •Patients will be required to score below 65 points on the IBS Quality of Life (IBS-QOL) instrument, indicating a score consistent with at least moderate HRQOL (Health-related quality of life) impairment.
排除标准
- •Patients will be excluded from the study if they have a comorbid disorder that may confound the diagnosis of IBS, including celiac disease, inflammatory bowel disease, autoimmune disorders that affect the GI system, history of bowel resection, HIV/AIDS, diabetes with HgA1c >7.0, neuroendocrine tumors, microscopic colitis, lactase deficiency, eosinophilic bowel disease, acute intermittent porphyria, or any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude.
- •Patients with severe depression, defined as a score equal to or greater than two standard deviations (SDs) on the NIH PROMIS depression scale, or those with suicidal ideations, will also be excluded and provided with standard resources to support their mental health and referred back to their primary care provider, a member of the study team will follow up with the PCP to ensure the communication was received.
- •Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia.
- •Patients will also be excluded from the study if they do not meet Rome IV criteria for IBS-C,
- •have a known seizure disorder,
- •if symptoms are thought to represent an organic disorder,
- •if they have had prior surgery to the colon,
- •if symptoms represent a known pelvic floor disorder,
- •if the patient is abusing alcohol,
- •or if the patient cannot actively participate in the study for any other reason (e.g., inability to understand English as the VR program is in English only).
- •Patients previously treated with linaclotide who reported side effects,
- •those currently on linaclotide (any dose),
- •and those who did not note an improvement in IBS-C symptoms in the past while on linaclotide will also be excluded.
研究组 & 干预措施
Sham VR
Patients in the sham Virtual Reality group will receive the same brand of head mounted device (Oculus Quest 2), but will only have access to sham content. Both groups will receive standard of care linaclotide treatment 290 mcg.
干预措施: Virtual Reality (Device)
Immersive VR
Patients in the immersive Virtual Reality group will receive a head mounted VR device Oculus Quest 2, and will receive active immersive content. Both groups will receive standard of care linaclotide treatment 290 mcg.
干预措施: Virtual Reality (Device)
结局指标
主要结局
Changes in IBS symptoms
时间窗: End of study week 8 compared to baseline
Measure global changes in IBS symptoms using the validated IBS severity scoring system (IBS-SSS) at week 8 compared to baseline, for patients treated with a combination of linaclotide and immersive VR and compare to those treated with linaclotide and sham VR therapy. IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500. \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS.
次要结局
- Measure changes in abdominal pain using the NRS(Week 8)
- Measure changes in work productivity using the validated WPAI.(Week 8)
- Measure change in quality of life, using the validated IBS-QoL(Week 8)
- Measure changes in bloating using the Mayo bloating questionnaire(week 8)
- Measure changes in psychological distress using the HADs questionnaire;(week 8)