Evaluating the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cann… (NCT07066579) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients
60 participantsStarted 2025-09-01
Plain-language summary
The goal of this clinical trial is to evaluate whether the Valsalva maneuver reduces invasive pain during arteriovenous fistula (AVF) cannulation in adult hemodialysis patients. The main questions it aims to answer are:
Does the Valsalva maneuver effectively reduce pain intensity during AVF cannulation as measured by the Visual Analogue Scale (VAS)?
Is the Valsalva maneuver feasible, acceptable, and satisfactory for patients, and can it be sustainably implemented over multiple sessions?
Researchers will compare patients performing the Valsalva maneuver (intervention group) with those receiving standard care without any intervention (control group) to see if pain scores are significantly lower and whether patients are willing to continue using this technique voluntarily.
Participants will:
Receive training and supervised practice on the Valsalva maneuver before inclusion in the study
Perform the Valsalva maneuver during AVF cannulation in each hemodialysis session for 12 sessions
Complete VAS pain assessments after each session
Complete a patient satisfaction and feasibility form at the end of the study
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years or older
* Receiving hemodialysis treatment via arteriovenous fistula for at least 3 months
* No analgesic medication use within the past 24 hours
* Systolic blood pressure between 90-160 mmHg and diastolic between 60-100 mmHg
* Pain score ≥ 1 on Visual Analogue Scale during AVF cannulation
* Able to perform the Valsalva maneuver (no contraindications)
* No communication barriers or severe psychiatric disorders
* Provided written informed consent
Exclusion Criteria:
* Unable to correctly perform the Valsalva maneuver
* Failed first cannulation attempt
* History of acute myocardial infarction or malignant arrhythmia
* Aneurysm, infection, edema, or scar tissue at AVF site
* Pregnancy
* Voluntary withdrawal from the study at any stage
* Switching dialysis centers or requiring hospitalization during the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity During AVF Cannulation Assessed by Visual Analogue Scale (VAS)
Timeframe: Up to 12 hemodialysis sessions (approximately 3 months)