About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Valsalva Maneuver
BehavioralPatients are instructed to perform the Valsalva maneuver by blowing into a 10-cc syringe to generate approximately 20 mmHg pressure for 15-20 seconds before arteriovenous fistula cannulation during each dialysis session.
Treatment groups
Trial outcomes
Primary outcomes
Pain Intensity During AVF Cannulation Assessed by Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 0-10 scale where 0 means no pain and 10 means the worst possible pain, immediately after each AVF cannulation session.
Secondary outcomes
Patient Satisfaction With the Valsalva Maneuver
Patient satisfaction regarding the feasibility, comfort, and willingness to continue using the Valsalva maneuver will be assessed through a structured satisfaction form at the end of the study period.
Feasibility of Performing the Valsalva Maneuver
The feasibility of performing the Valsalva maneuver will be evaluated based on patients' ability to correctly perform the maneuver and their reports of any difficulties during the study period.
Locations
Sponsors and contacts
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Cansu POLAT DÜNYA
Lead sponsor
Istanbul University
Sponsor institution
Istanbul University Scientific Research Projects Coordination Unit- Pending
Collaborator
This trial is not recruiting at the moment. You can still explore other options: