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New treatment option for Colonoscopy
Official title Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System
ClinicalTrials.gov ID: NCT06813703
What this study is testing
- What it's testing
- This study is a single-center, randomized controlled trial aiming to evaluate the analgesic mechanism of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) during unsedated colonoscopy using EEG-fNIRS technology to assess neural activity in brain regions associated with pain perception. Sixty patients aged 18-75 years, with stable cardiopulmonary function and a baseline visual analog scale (VAS) pain score \<3, will be enrolled and randomly allocated into the intervention and control groups.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients undergoing unsedated colonoscopy are eligible for inclusion in this study.
- Aged 18 to 75 years.
- Meeting the requirements for colonoscopy, with good cardiopulmonary function and stable vital signs.
- A pre-procedural Visual Analog Scale (VAS) pain score of less than 3.
You likely can't join if
- Participants with speech or cognitive impairments.
- Those with acute anal or rectal stenosis, acute perianal or rectal infections, acute diverticulitis, or active inflammatory bowel disease.
- Women who are menstruating, pregnant, or breastfeeding.
- Patients with active tuberculosis, hemophilia, or advanced malignant tumors.
- Individuals with sensory disturbances, implanted pacemakers or defibrillators, or ankle skin ulcers.
- Those who have used sedatives or analgesics either long-term or within the past 24 hours.
See the full eligibility criteria
- Patients undergoing unsedated colonoscopy are eligible for inclusion in this study.
- Aged 18 to 75 years.
- Meeting the requirements for colonoscopy, with good cardiopulmonary function and stable vital signs.
- A pre-procedural Visual Analog Scale (VAS) pain score of less than 3.
- Participants with speech or cognitive impairments.
- Those with acute anal or rectal stenosis, acute perianal or rectal infections, acute diverticulitis, or active inflammatory bowel disease.
- Women who are menstruating, pregnant, or breastfeeding.
- Patients with active tuberculosis, hemophilia, or advanced malignant tumors.
- Individuals with sensory disturbances, implanted pacemakers or defibrillators, or ankle skin ulcers.
- Those who have used sedatives or analgesics either long-term or within the past 24 hours.
- Individuals with any condition that interferes with EEG-fNIRS signal acquisition, such as cranial abnormalities, implanted metal or electronic devices, epilepsy, or neurological disorders.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.