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NCT Number: NCT07066579

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain Intensity During AVF Cannulation Assessed by Visual Analogue Scale (VAS)

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

    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

  1. Patient Satisfaction With the Valsalva Maneuver

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

    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.

  2. Feasibility of Performing the Valsalva Maneuver

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cansu Polat Dunya, Assoc Prof

CONTACT

[email protected]

0905452818917

Sponsors and collaborators

Lead sponsor

Cansu POLAT DÜNYA

Other

Collaborators

  • Istanbul University Scientific Research Projects Coordination Unit- Pending

Registry information

Official study title

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

Acronym: VALPAIN-HD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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