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

NCT07066579 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-15

No results posted yet for this study

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Istanbul University Scientific Research Projects Coordination Unit- Pending

    collaborator UNKNOWN

  • Cansu POLAT DÜNYA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-06-01
Completion
2026-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07066579 on ClinicalTrials.gov