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.
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 1. Evaluate changes in quality of life using the validated IBS-QoL (primary outcome); 2. Evaluate global improvement in IBS symptoms using the validated IBS-SSS; 3. Assess global improvement in IBS symptoms using the validated Abdominal Scoring system (11); 4. Evaluate improvement in abdominal pain using a numerical rating system (NRS); 5. Assess improvement in constipation using the Bristol Stool Form Scale (BSFS); 6. Evaluate response to bloating using the validated Mayo bloating questionnaire (12); 7. Assess response to coexisting psychological distress using the validated HADs questionnaire; 8. Evaluate changes in work productivity using the validated WPAI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
65
Both groups will receive standard of care linaclotide 290 mcg.
Mayo Clinic Florida
Jacksonville, Florida, United States
RECRUITINGChanges in IBS symptoms
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.
Time frame: End of study week 8 compared to baseline
Measure change in quality of life, using the validated IBS-QoL
Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL) The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Time frame: Week 8
Measure changes in abdominal pain using the NRS
The Abdominal Pain Numeric Rating Scale (NRS) patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Time frame: Week 8
Measure changes in bloating using the Mayo bloating questionnaire
A 40-item questionnaire to understand the daily impact of symptoms of bloating and distension
Time frame: week 8
Measure changes in psychological distress using the HADs questionnaire;
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'
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Time frame: week 8
Measure changes in work productivity using the validated WPAI.
The Work Productivity and Activity Impairment (WPAI) questionnaire consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities
Time frame: Week 8