NCT07066579

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cansu POLAT DÜNYA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Arteriovenous fistula (AVF) cannulation is a frequent and essential procedure for patients receiving maintenance hemodialysis, yet it often causes moderate to severe pain and anxiety, which can negatively affect patients' treatment adherence and quality of life. Although pharmacological methods are commonly used to manage cannulation-related pain, they can be costly and have potential side effects. Therefore, there is increasing interest in simple, low-cost, non-pharmacological techniques. The Valsalva maneuver is a physiological technique that increases intrathoracic pressure through forced exhalation against a closed airway, stimulating the vagus nerve and providing an antinociceptive effect. Previous studies have shown that the Valsalva maneuver reduces pain in various invasive procedures such as intravenous cannulation and spinal puncture; however, evidence for its efficacy during AVF cannulation in hemodialysis patients is limited and methodologically weak. This randomized controlled, single-blind trial aims to evaluate the effectiveness of the Valsalva maneuver in reducing pain intensity during AVF cannulation among adult hemodialysis patients. The study also investigates the feasibility, sustainability, and patient satisfaction associated with the use of this maneuver. Patients in the intervention group will receive training on the Valsalva maneuver and perform it during each cannulation session over 12 hemodialysis sessions. Pain intensity will be measured using the Visual Analogue Scale (VAS) immediately after each session. At the end of the study, patient feedback regarding the acceptability and ease of use of the maneuver will be collected through a structured form. This study is designed to provide high-level evidence supporting a cost-effective, easily applicable, and non-pharmacological approach to pain management during AVF cannulation, potentially contributing to improved patient comfort and adherence to hemodialysis treatment.

Conditions

• Arteriovenous Fistula
• Pain
• Hemodialysis Access Failure
• Vascular Access Device Complications

Interventions

Type	Name	Description
BEHAVIORAL	Valsalva Maneuver	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2025-07-15
• Last updated: 2025-07-15