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

NCT07066579 | Not Yet Recruiting

• 2 other identifiers: 12.06.2025/335489442077
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hemodialysis; Arteriovenous Fistula; Cannulation Pain; Valsalva Maneuver

Outcome Measures

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.

  Up to 12 hemodialysis sessions (approximately 3 months)

Secondary Outcomes (2)

• Patient Satisfaction With the Valsalva Maneuver

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

• Feasibility of Performing the Valsalva Maneuver

  Up to 12 hemodialysis sessions (approximately 3 months)

Study Arms (2)

Valsalva Maneuver Group

EXPERIMENTAL

Patients perform the Valsalva maneuver during AVF cannulation in each dialysis session.

Behavioral: Valsalva Maneuver

Control Group

NO INTERVENTION

Patients receive standard AVF cannulation care without any additional intervention.

Interventions

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.

Valsalva Maneuver Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cansu POLAT DÜNYA: lead
• Istanbul University Scientific Research Projects Coordination Unit- Pending: collaborator

Related Publications (3)

• Babamohamadi H, Ameri Z, Asadi I, Asgari MR. Comparison of the Effect of EMLA Cream and the Valsalva Maneuver on Pain Severity during Vascular Needle Insertion in Hemodialysis Patients: A Controlled, Randomized, Clinical Trial. Evid Based Complement Alternat Med. 2022 Aug 31;2022:8383021. doi: 10.1155/2022/8383021. eCollection 2022.

  PMID: 36091600 BACKGROUND

• Hosseini SJ, Manzari ZS, Karkhah S, Heydari A. The effects of Valsalva maneuver on pain intensity and hemodynamic status during short peripheral cannula insertion in adults: A systematic review and meta-analysis. J Vasc Access. 2024 Jul;25(4):1051-1062. doi: 10.1177/11297298221145982. Epub 2022 Dec 27.

  PMID: 36573708 BACKGROUND

• Alzaatreh MY, Abdalrahim MS. Management Strategies for Pain Associated with Arteriovenous Fistula Cannulation: An Integrative Literature Review. Hemodial Int. 2020 Jan;24(1):3-11. doi: 10.1111/hdi.12803. Epub 2019 Dec 3.

  PMID: 31797508 RESULT

MeSH Terms

Conditions

Arteriovenous Fistula; Pain

Interventions

Valsalva Maneuver

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Respiratory Physiological Phenomena

Central Study Contacts

Cansu Polat Dunya, Assoc Prof

CONTACT

0905452818917; cansu.polat@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor (dialysis nurse) is blinded to group allocation to reduce assessment bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Associate Professor

Model Details: Two-arm parallel design comparing Valsalva maneuver with standard care.

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of primary results; available for up to 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal and agree to use the data only for meta-analysis or pooled analysis purposes. Requests should be directed to the principal investigator.