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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT012917-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Florida State University | OTHER |
| Rutgers University | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The goal of this clinical trial is to learn the feasibility and safety of using home-based taVNS in young adults with IBS to manage their IBS-related pain and symptoms. It will also learn about participants' experience in using the home-based taVNS intervention. The main questions it aims to answer are:
Participants will:
This pilot randomized controlled study aims to evaluate the feasibility, acceptability, adherence, safety, and potential implementation barriers of home-based taVNS intervention in YAs (18-29 years old) diagnosed with IBS. A two-site, two-arm, parallel, proof-of-concept randomized trial will be conducted to assess the feasibility of using the Active taVNS intervention compared with Sham taVNS in managing IBS-related pain and symptoms. Eighty YAs meeting the Rome IV diagnostic criteria of IBS will be recruited and receive either Active or Sham taVNS for pain and symptom management, along with self-management education and their usual treatment and care. After enrollment and a 2-week baseline run-in period, participants will be randomized to the Active or Sham taVNS with a 6-week treatment (30 minutes per session, twice daily for 6 weeks) and be followed up for another 6 weeks of post-treatment. Investigators will assess feasibility through recruitment rates, adherence, factors influencing adherence, safety, satisfaction, and collection of patient-reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active taVNS intervention | Experimental | Active taVNS twice daily, 30 minutes per session, over 6 weeks. |
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| Sham taVNS | Sham Comparator | Sham taVNS twice daily, 30 minutes per session, over 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based taVNS intervention | Device | Home-based taVNS intervention will be administered using the non-invasive taVNS device, Parasym system (Parasym Health, Inc, London, UK). |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of implementing taVNS - Retention rates | Feasibility will be assessed by evaluating the retention rate of participants who complete the taVNS sessions at 6 weeks and the follow-up at week 12. Retention rates will be calculated by comparing the number of participants who complete these timepoints with the baseline data. | Baseline, week 6, week 12 |
| Adherence of implementing taVNS - Duration of usage | Adherence will be measured using participant self-report data and the data from the taVNS monitoring system. Actual usage time (minutes) will be extracted from the Parasym system recorder to monitor the adherence to the study protocol. | week 6 |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in using the taVNS will be measured using self-reported data, including online self-monitoring diary, weekly meetings with the research team, surveys, and focus group interviews. Adverse events (AEs) will be monitored daily using the online diary with a preset form, including a 10-item survey to assess daily AEs of taVNS on 0-10 Likert scales. | Baseline, week 6, week 12 |
| Satisfaction in implementing taVNS | Satisfaction in using the taVNS will be measured using self-reported data including online self-monitoring diary, weekly meetings with the research team, surveys, and focus group interviews. | Baseline, week 6, week 12 |
| Change in pain intensity assessed using the Brief Pain Inventory (BPI) | The BPI has a total score range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Total pain severity score can be found by averaging all items. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaomei S Cong, PhD | Contact | 8606179849 | xiaomei.cong@yale.edu | |
| Jie Chen, PhD | Contact | 850-645-0657 | jc22db@fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Xiaomei S Cong | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06511 | United States |
Scientific data will be shared as soon as possible. Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award period. Under the current repository policies, data published in Dryad are permanently archived and available for broader research.
Scientific data will be shared as soon as possible. Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award period. Under the current repository policies, data published in Dryad are permanently archived and available for broader research.
By the request of the researchers
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D043183 | Irritable Bowel Syndrome |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Blinding procedures will be implemented for the participants, data collectors, and data analysts to minimize bias and increase study validity.
| Baseline, week 6 and week 12 |
| Changes in IBS symptoms using IBS Symptom Severity Scale (IBS-SSS) | IBS Symptom Severity Scale (IBS-SSS) will be used to measure IBS symptom severity using 100-point scales on five items: severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life. | Baseline, week 6, week 12 |
| Changes in IBS-related Psychophysiological Symptoms - Anxiety using Patient-Reported Outcomes Measurement Information System (PROMIS®) Anxiety 4a | IBS-related Psychophysiological Symptoms - Anxiety will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) Anxiety 4a measuring for Anxiety. Raw scores range from 4 to 20, with T-scores ranging from 40.3±6.1 to 81.6±3.7. A higher PROMIS T-score represents more of the concept being measured. | Baseline, week 6, week 12 |
| Changes in IBS-related Psychophysiological Symptoms - Fatigue using Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue 4a | IBS-related Psychophysiological Symptoms will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue 4a measuring for Fatigue. Raw scores range from 4 to 20, with T-scores ranging from 33.7±4.9 to 75.8±3.9. A higher PROMIS T-score represents more of the concept being measured. | Baseline, week 6, week 12 |
| Changes in IBS-related Psychophysiological Symptoms - Depression using Patient-Reported Outcomes Measurement Information System (PROMIS®) Depression 4a | IBS-related Psychophysiological Symptoms will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) measuring for Depression. Raw scores range from 4 to 20, with T-scores ranging from 41.0±6.2 to 70.4±2.6. A higher PROMIS T-score represents more of the concept being measured. | Baseline, week 6, week 12 |
| Changes in IBS-related Psychophysiological Symptoms - Applied Cognition using Patient-Reported Outcomes Measurement Information System (PROMIS®) Applied Cognition Abilities 4a | IBS-related Psychophysiological Symptoms will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) measuring for Applied Cognition. Raw scores range from 4 to 20, with T-scores ranging from 30.1± 4.44 to 63.8±5.2. A higher PROMIS T-score represents more of the concept being measured. | Baseline, week 6, week 12 |
| Changes in IBS-related Psychophysiological Symptoms - Sleep using Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance 4a | IBS-related Psychophysiological Symptoms will be measured using Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance 4a measuring for sleep disturbance. Raw scores range from 4 to 20, with T-scores ranging from 32.0±5.2 to 73.3±4.6. A higher PROMIS T-score represents more of the concept being measured. | Baseline, week 6, week 12 |
| Changes in IBS related psychosocial factors - Stress using Perceived Stress Scale-10 (PSS-10) | IBS related psychosocial factors - stress will be measured using Perceived Stress Scale-10 (PSS-10). The scale consists of 10 items each rated on a 5-point rating scale from "never" to "very often." The sum score ranges from 0 to 40, where a higher score indicates a higher level of stress. | Baseline, week 6, week 12 |
| Changes in IBS-related quality of life using IBS-Quality of Life (IBS-QOL) Questionnaire | IBS-related quality of life will be measured using IBS-Quality of Life (IBS-QOL) Questionnaire. The IBS-QOL consists of 34 self-report items and a five-point Likert scale (0 to 4) is used to measure participants' feelings. The total scores are calculated as the sum of all item scores ranging from 0 to 136 and higher scores show better QOL. | Baseline, week 6, week 12 |
| Changes in IBS related psychosocial factors - Self-Efficacy using IBS Self-Efficacy Scale (IBS-SE) | IBS Self-Efficacy Scale (IBS-SE) will be used to measure patients' confidence in their ability to manage IBS abdominal pain and episodes using a 7-point Likert scale on 25 items. The sum of the items derives a total score ranging from 25 to 175. Higher scores indicate higher levels of self-efficacy for IBS symptom control and management. | Baseline, week 6, week 12 |
| Changes in IBS related psychosocial factors - Pain Catastrophizing using Brief Pain Catastrophizing Scale (Brief-PCS) | Brief Pain Catastrophizing Scale (Brief-PCS) will be used to measure the perception of pain catastrophizing, which includes 4-item brief version of the PCS, using 5-point scale. The Brief-PCS has a score range 0-16 and higher scores indicate a higher level of catastrophizing. | Baseline, week 6, week 12 |
| Changes in IBS related psychosocial factors - Coping using Coping Strategies Questionnaire-Revised (CSQ-R) | Coping Strategies Questionnaire-Revised (CSQ-R) will be used to measure coping strategies in managing IBS-related pain. It is a 27-item questionnaire designed to assess six cognitive coping responses to pain. Subjects rate the frequency of using each coping strategy and perceived control over their pain on a 7-point Likert-type scale (0-6). Total scores range from 0 to 162 with higher scores indicating greater use of coping strategies. | Baseline, week 6, week 12 |
| Changes in IBS related psychosocial factors - Emotion Regulation using Difficulties in Emotion Regulation Scale (DERS) | Difficulties in Emotion Regulation Scale (DERS) will be used to measure IBS related emotion regulation. DERS is a 36-itme self-report measure of individuals' abilities to respond to emotional experience in a goal-oriented manner, using a 5-point Likert scale. Total scores range from 36 to 180, with higher scores indicating greater difficulties in emotion regulation. | Baseline, week 6, week 12 |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D004194 | Disease |
| D010335 | Pathologic Processes |