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

NCT ID: NCT07066579

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Valsalva Maneuver Group

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

Group Type: EXPERIMENTAL

Valsalva Maneuver

Intervention Type: 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.

Control Group

Patients receive standard AVF cannulation care without any additional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University Scientific Research Projects Coordination Unit- Pending

UNKNOWN

Sponsor Role: collaborator

Cansu POLAT DÜNYA

OTHER

Sponsor Role: lead

Responsible Party

Cansu POLAT DÜNYA

PhD, Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Cansu Polat Dunya, Assoc Prof

Role: CONTACT

cansu.polat@istanbul.edu.tr

0905452818917

References

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.

Reference Type: BACKGROUND

PMID: 36091600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36573708 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31797508 (View on PubMed)

Other Identifiers

42077

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12.06.2025/3354894

Identifier Type: -

Identifier Source: org_study_id