Evaluating the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCansu POLAT DÜNYA

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Valsalva Maneuver

    Behavioral

    Patients 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

60 Participants
are divided into 2 treatment groups
Group A: Valsalva Maneuver GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 12 hemodialysis sessions (approximately 3 months)

Secondary outcomes

1

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.

Time frame
At the end of 12 hemodialysis sessions (approximately 3 months)
2

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.

Time frame
Up to 12 hemodialysis sessions (approximately 3 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: