Pain, ChronicIBS-taVNSNCT06847360
Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain
A study testing Home-based taVNS intervention in people with Pain, Chronic and Irritable Bowel Syndrome, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Pain, Chronic, Irritable Bowel Syndrome, Symptom Cluster
- What is being tested?
- Home-based taVNS intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 29 years of age;
- Men and women;
- Diagnosis of IBS from a healthcare provider with current report of pain (volunteers asked to bring provider-verification of IBS diagnosis based on Rome IV criteria to initial study appointment);
- Experiencing moderate pain (≥3 out of 10 on numeric rating scale [NRS]) at least 4 days of the week and lasting previous three months;
- Daily access to a computer connected to the internet; and
- Able to read and speak English.
Who cannot join
- Other chronic pain condition;
- Celiac disease or inflammatory bowel disease;
- Diabetes mellitus;
- severe psychiatric condition requiring inpatient treatment in previous 6 months;
- Pregnancy or lactation;
- Regular use of opioids or other illicit substances;
- use of probiotics or antibiotics within 2 weeks from enrollment; and
- any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06511
Xiaomei S Cong, PhD
Jie Chen, PhD, 850-645-0657, jc22db@fsu.edu
About this study
Official title: Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management Among Young Adults With Irritable Bowel Syndrome (IBS)
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:
- Is it feasible to use a home-based taVNS intervention for pain and symptom management among YAs with IBS?
- Is it safe and reported satisfactory to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? Researchers will compare Active to Sham taVNS (a look-alike intervention that contains minimal stimulation) to see if Active taVNS works on managing IBS-related pain and symptoms.
Read more
Participants will:
- Take Active or Sham taVNS intervention for a 6-week treatment (twice daily, 30 minutes per session)
- Visit the research lab at the initial setup and the end of the 6-week treatment for checkups and tests
- Keep a diary of their symptoms and the number of times they use the taVNS.
Read the detailed description
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.
- Conditions
- Pain, Chronic, Irritable Bowel Syndrome, Symptom Cluster
- Being tested
- Home-based taVNS intervention
- Medical subject headings
- Chronic Pain, Irritable Bowel Syndrome, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based taVNS interventionDevice
Home-based taVNS intervention will be administered using the non-invasive taVNS device, Parasym system (Parasym Health, Inc, London, UK).
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS intervention | Experimental | Active taVNS twice daily, 30 minutes per session, over 6 weeks. Receives: Device: Home-based taVNS intervention |
| Sham taVNS | Sham comparator | Sham taVNS twice daily, 30 minutes per session, over 6 weeks. Receives: Device: Home-based taVNS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
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.
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.
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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start19 Jan 2026
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Florida State University, Rutgers University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Xiaomei S Cong, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847360
- Sponsor's protocol ID
- 2000039295
- Other IDs
- R34AT012917-01A1
- Acronym
- IBS-taVNS
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management Among Young Adults With Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT06847360
- Acronym / sponsor ID
- IBS-taVNS / 2000039295
- Conditions
- Pain, Chronic, Irritable Bowel Syndrome, Symptom Cluster
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Florida State University, Rutgers University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it feasible to use a home-based taVNS intervention for pain and symptom management among YAs with IBS?
- Is it safe and reported satisfactory to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? Researchers will compare Active to Sham taVNS (a look-alike intervention that contains minimal stimulation) to see if Active taVNS works on managing IBS-related pain and symptoms.
Participants will:
- Take Active or Sham taVNS intervention for a 6-week treatment (twice daily, 30 minutes per session)
- Visit the research lab at the initial setup and the end of the 6-week treatment for checkups and tests
- Keep a diary of their symptoms and the number of times they use the taVNS.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active taVNS intervention | Experimental | Device: Home-based taVNS interventionActive taVNS twice daily, 30 minutes per session, over 6 weeks. |
| Sham taVNS | Sham comparator | Device: Home-based taVNS interventionSham taVNS twice daily, 30 minutes per session, over 6 weeks. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 - 29 years of age;
- Men and women;
- Diagnosis of IBS from a healthcare provider with current report of pain (volunteers asked to bring provider-verification of IBS diagnosis based on Rome IV criteria to initial study appointment);
- Experiencing moderate pain (≥3 out of 10 on numeric rating scale [NRS]) at least 4 days of the week and lasting previous three months;
- Daily access to a computer connected to the internet; and
Key exclusion criteria (8 listed)
- Other chronic pain condition;
- Celiac disease or inflammatory bowel disease;
- Diabetes mellitus;
- severe psychiatric condition requiring inpatient treatment in previous 6 months;
- Pregnancy or lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based taVNS interventionHome-based taVNS intervention will be administered using the non-invasive taVNS device, Parasym system (Parasym Health, Inc, London, UK). | Device | Active taVNS intervention, Sham taVNS |
Primary outcome
Feasibility of implementing taVNS - Retention rates
Time frame: Baseline, week 6, week 12
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.
Adherence of implementing taVNS - Duration of usage
Time frame: week 6
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.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Baseline, week 6, week 12
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.
Satisfaction in implementing taVNS
Time frame: Baseline, week 6, week 12
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.
Change in pain intensity assessed using the Brief Pain Inventory (BPI)
Time frame: Baseline, week 6 and week 12
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.
Changes in IBS symptoms using IBS Symptom Severity Scale (IBS-SSS)
Time frame: Baseline, week 6, week 12
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.
Changes in IBS-related Psychophysiological Symptoms - Anxiety using Patient-Reported Outcomes Measurement Information System (PROMIS®) Anxiety 4a
Time frame: Baseline, week 6, week 12
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.
Changes in IBS-related Psychophysiological Symptoms - Fatigue using Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue 4a
Time frame: Baseline, week 6, week 12
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.
Changes in IBS-related Psychophysiological Symptoms - Depression using Patient-Reported Outcomes Measurement Information System (PROMIS®) Depression 4a
Time frame: Baseline, week 6, week 12
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.
Changes in IBS-related Psychophysiological Symptoms - Applied Cognition using Patient-Reported Outcomes Measurement Information System (PROMIS®) Applied Cognition Abilities 4a
Time frame: Baseline, week 6, week 12
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.
Changes in IBS-related Psychophysiological Symptoms - Sleep using Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance 4a
Time frame: Baseline, week 6, week 12
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.
Changes in IBS related psychosocial factors - Stress using Perceived Stress Scale-10 (PSS-10)
Time frame: Baseline, week 6, week 12
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.
Changes in IBS-related quality of life using IBS-Quality of Life (IBS-QOL) Questionnaire
Time frame: Baseline, week 6, week 12
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.
Changes in IBS related psychosocial factors - Self-Efficacy using IBS Self-Efficacy Scale (IBS-SE)
Time frame: Baseline, week 6, week 12
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.
Changes in IBS related psychosocial factors - Pain Catastrophizing using Brief Pain Catastrophizing Scale (Brief-PCS)
Time frame: Baseline, week 6, week 12
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.
Changes in IBS related psychosocial factors - Coping using Coping Strategies Questionnaire-Revised (CSQ-R)
Time frame: Baseline, week 6, week 12
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.
Changes in IBS related psychosocial factors - Emotion Regulation using Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline, week 6, week 12
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaomei S Cong principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based taVNS intervention in people with Pain, Chronic and Irritable Bowel Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei S Cong, PhD (8606179849, xiaomei.cong@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing taVNS - Retention rates (time frame: Baseline, week 6, week 12). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.