Combined Effects of Transcutaneous Auricular Vagus Nerve Stimulation and Pelvic Floor Rehabilitation in Patients With Dyssynergic Defecation: A Randomized Controlled Trial
NCT07934004, Not applicable, Completed, Istanbul Bilgi University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Combined Effects of Transcutaneous Auricular Vagus Nerve Stimulation and Pelvic Floor Rehabilitation in Patients With Dyssynergic Defecation: A Randomized Controlled Trial | ClinicalTrials.gov |
| NCT number | NCT07934004 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 32 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Istanbul Bilgi University | ClinicalTrials.gov |
| Conditions | Dyssynergic Defecation | ClinicalTrials.gov |
| Interventions | Biofeedback-Based Pelvic Floor Rehabilitation, Transcutaneous Auricular Vagus Nerve Stimulation (Active taVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS) | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Constipation Severity Instrument (CSI) Total Score | Baseline and 2 months (post-intervention) | Constipation severity was assessed using the 16-item Constipation Severity Instrument (CSI), comprising three subscales: obstructive defecation (0-28 points), colonic inertia (0-29 points), and pain (0-16 points). The total score ranges from 0 to 73, with higher scores indicating greater constipation severity. Changes in total CSI scores from baseline to post-intervention were compared between the active taVNS and sham taVNS groups. | ClinicalTrials.gov |
| Secondary | Change in Colorectal-Anal Distress Inventory-8 (CRADI-8) Score | Baseline and 2 months (post-intervention) | Colorectal and anal symptom distress was assessed using the eight-item Colorectal-Anal Distress Inventory (CRADI-8), a subscale of the Pelvic Floor Distress Inventory-20 (PFDI-20). Scores range from 0 to 100, with higher scores indicating greater symptom distress. Changes in scores from baseline to post-intervention were compared between the active taVNS and sham taVNS groups. | ClinicalTrials.gov |
| Secondary | Change in Patient Assessment of Constipation Quality of Life (PAC-QOL) Score | Baseline and 2 months (post-intervention) | Constipation-related quality of life was assessed using the 28-item Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, comprising four domains: worries and concerns, physical discomfort, psychosocial discomfort, and satisfaction. Higher scores indicate a greater negative impact of constipation on quality of life. Changes from baseline to post-intervention were compared between the active taVNS and sham taVNS groups. | ClinicalTrials.gov |
| Secondary | Change in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score | Baseline and 2 months (post-intervention) | Anxiety symptoms were assessed using the seven-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score | Baseline and 2 months (post-intervention) | Depressive symptoms were assessed using the seven-item depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Scores range from 0 to 21, with higher scores indicating greater depressive symptoms. Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Pelvic Floor Muscle EMG Work Average (µV) | Baseline and 2 months (post-intervention) | Pelvic floor muscle electrical activity during contraction was assessed using surface electromyography (EMG) with the NeuroTrac MyoPlus2 Pro device. Work Average was recorded in microvolts (µV) during repeated five-second contractions. Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Pelvic Floor Muscle EMG Rest Average (µV) | Baseline and 2 months (post-intervention) | Pelvic floor muscle electrical activity during relaxation was assessed using surface electromyography (EMG) with the NeuroTrac MyoPlus2 Pro device. Rest Average was recorded in microvolts (µV) during repeated five-second relaxation periods. Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Heart Rate Variability - RMSSD (ms) | Baseline and 2 months (post-intervention) | Heart rate variability was assessed using the Polar H10 chest strap and Elite HRV application. RMSSD, the root mean square of successive differences between normal-to-normal RR intervals, was measured in milliseconds (ms). Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Heart Rate Variability - pNN50 (%) | Baseline and 2 months (post-intervention) | Heart rate variability was assessed using the Polar H10 chest strap and Elite HRV application. pNN50 represents the percentage of successive normal-to-normal RR intervals differing by more than 50 milliseconds. Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Heart Rate Variability - LF Power | Baseline and 2 months (post-intervention) | Low-frequency (LF) power was assessed through frequency-domain heart rate variability analysis using the Polar H10 chest strap and Elite HRV application. Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Heart Rate Variability - HF Power | Baseline and 2 months (post-intervention) | High-frequency (HF) power was assessed through frequency-domain heart rate variability analysis using the Polar H10 chest strap and Elite HRV application. Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Heart Rate Variability - LF/HF Ratio | Baseline and 2 months (post-intervention) | The ratio of low-frequency to high-frequency power (LF/HF) was calculated from heart rate variability measurements obtained using the Polar H10 chest strap and Elite HRV application. Changes from baseline to post-intervention were compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Weekly Bowel Movement Frequency | Baseline and 2 months (post-intervention) | Weekly bowel movement frequency was assessed using a defecation diary. The number of bowel movements per week was recorded at baseline and after the two-month intervention period. Changes in weekly bowel movement frequency were compared between the active taVNS and sham taVNS groups. Higher values indicate more frequent bowel movements. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)