Arteriovenous FistulaVALPAIN-HDNCT07066579
Evaluating the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients
A study testing Valsalva Maneuver in people with Arteriovenous Fistula and Pain, run by Cansu POLAT DÜNYA.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula, Pain, Hemodialysis Access Failure
- What is being tested?
- Valsalva Maneuver
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of 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)?
Read more
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
Read the 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
- Being tested
- Valsalva Maneuver
- Keywords
- Hemodialysis, Arteriovenous Fistula, Cannulation Pain, Valsalva Maneuver
- Medical subject headings
- Arteriovenous Fistula, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsalva ManeuverBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Valsalva Maneuver Group | Experimental | Patients perform the Valsalva maneuver during AVF cannulation in each dialysis session. Receives: Behavioral: Valsalva Maneuver |
| Control Group | No intervention | Patients receive standard AVF cannulation care without any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 hemodialysis sessions (approximately 3 months)
Secondary outcomes (2)
Patient Satisfaction With the Valsalva Maneuver
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.
Measured: At the end of 12 hemodialysis sessions (approximately 3 months)
Feasibility of Performing the Valsalva Maneuver
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.
Measured: Up to 12 hemodialysis sessions (approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel design comparing Valsalva maneuver with standard care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cansu POLAT DÜNYA
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University Scientific Research Projects Coordination Unit- Pending
- Responsible party
- Sponsor-investigator, Cansu POLAT DÜNYA, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066579
- Sponsor's protocol ID
- 12.06.2025/3354894
- Other IDs
- 42077
- Acronym
- VALPAIN-HD
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared upon reasonable request for meta-analysis purposes after publication of the primary results.
Publications
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.
PubMed 36091600Hosseini 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.
PubMed 36573708Alzaatreh 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.
PubMed 31797508
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07066579
- Acronym / sponsor ID
- VALPAIN-HD / 12.06.2025/3354894
- Conditions
- Arteriovenous Fistula, Pain, Hemodialysis Access Failure, Vascular Access Device Complications
- Keywords
- Hemodialysis, Arteriovenous Fistula, Cannulation Pain, Valsalva Maneuver
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cansu POLAT DÜNYAUniversity, hospital or other
- Collaborators
- Istanbul University Scientific Research Projects Coordination Unit- Pending
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel design comparing Valsalva maneuver with standard care.
| Arm | Type | Receives |
|---|---|---|
| Valsalva Maneuver Group | Experimental | Behavioral: Valsalva ManeuverPatients perform the Valsalva maneuver during AVF cannulation in each dialysis session. |
| Control Group | No intervention | –Patients receive standard AVF cannulation care without any additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsalva ManeuverPatients 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. | Behavioural | Valsalva Maneuver Group |
Primary outcome
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.
2 secondary outcomes
Patient Satisfaction With the Valsalva Maneuver
Time frame: At the end of 12 hemodialysis sessions (approximately 3 months)
Feasibility of Performing the Valsalva Maneuver
Time frame: Up to 12 hemodialysis sessions (approximately 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 36091600Babamohamadi 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.
- Background: PubMed 36573708Hosseini 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.
- Results publication: PubMed 31797508Alzaatreh 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared upon reasonable request for meta-analysis purposes after publication of the primary results.
Related trials for Arteriovenous Fistula
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Not yet recruiting
Ultrasound Guidance Intercostobrachial Nerve Block in AVF Superficialization
Supraclavicular Plexus Block Procedure (SCPB), ESRD
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Valsalva Maneuver in people with Arteriovenous Fistula and Pain, run by Cansu POLAT DÜNYA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cansu Polat Dunya, Assoc Prof (0905452818917, cansu.polat@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity During AVF Cannulation Assessed by Visual Analogue Scale (VAS) (time frame: Up to 12 hemodialysis sessions (approximately 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07066579, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.