Effect of Mirror Therapy on the Arteriovenous Fistula Cannulation-related Pain and Anxiety

NCT ID: NCT06683495

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-05

Study Completion Date

2025-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pharmacological and non-pharmacological methods are frequently used to reduce cannulation-related pain in patients with fistulas. Non-pharmacological approaches have been more favored than pharmacological approaches for some reasons, including ease of use and fewer side effects. Patients describe worry about the success of needling and resigned acceptance of pain and anxiety about dialysis needles. With this background in mind, mirror therapy has been introduced as one of the non-pharmacological interventions in the domain of pain management.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients undergoing hemodialysis experience pain, anxiety and stress due to large-gauge needle punctures necessary to ensure efficient arteriovenous fistula flow. In addition, anxiety disorders are prevalent in hemodialysis patients, primarily caused by invasive procedures and dialysis machine alarm sounds. Patients describe worry about the success of needling and resigned acceptance of pain and anxiety about dialysis needles. Therefore, when performing an AVF puncture, nursing care should prioritise the management of pain and anxiety. With this background in mind, mirror therapy has been introduced as one of the non-pharmacological interventions in the domain of pain management. It has been reported that viewing the picture of a healthy limb could moderate pain perception in the affected one

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Chronic Fistula Hemodialysis Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mirror Therapy

For mirror therapy, a 50×40 cm mirror will be used. The patient will be positioned in a semi-sitting position at a 45° angle in bed, with the mirror placed on the side of the body where the access will be made. The arm with the fistula will be positioned behind the mirror. The position will be standardized so that the patient's thumb is 30 cm away from the mirror. The arm without the fistula will be supported with a pillow underneath to facilitate the patient's view in the mirror, positioned next to the patient. After observing their arm in the mirror for 15 minutes, the cannulation procedure will be performed.

Group Type EXPERIMENTAL

Mirror Therapy

Intervention Type OTHER

For mirror therapy, a 50×40 cm mirror will be used

Routine Therapy

The routine procedure was performed. The fistula puncture was performed by the same nurse throughout the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mirror Therapy

For mirror therapy, a 50×40 cm mirror will be used

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 18 years and older
* Patients who received hemodialysis (HD) treatment with an arteriovenous fistula (AVF) for at least 3 months
* Patients receiving HD treatment 3 days a week for 4 hours each session
* Patients with a pain score of ⩾1 during AVF cannulation, measured by a visual analog scale (VAS)
* Patients able to communicate in Turkish
* Patients without psychiatric disorders that impair communication
* Patients who agreed to participate in the study

Exclusion Criteria

* Patients who were known to present difficulties with fistula cannulation (requiring multiple cannulations)
* Patients with a history of hematoma or stenosis in the arteriovenous fistula (AVF)
* Patients with an infection at the fistula site
* Patients who took painkillers within 3 hours prior to treatment
* Patients unable to maintain a sitting position on the bed
* Patients with low vision or visual disturbances (30 cm or less)
* Patients who did not wish to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nurten Ozen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nurten Ozen, Assoc.Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Caglar S, Ozen N. Investigation of the effect of breathing exercise on invasive pain associated with arteriovenous fistula cannulation in hemodialysis patients: Randomized controlled, single-blind study. J Vasc Access. 2024 Nov;25(6):1940-1947. doi: 10.1177/11297298231194756. Epub 2023 Aug 24.

Reference Type RESULT
PMID: 37615173 (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)

Ozen N, Tosun B, Sayilan AA, Eyileten T, Ozen V, Ecder T, Tosun N. Effect of the arterial needle bevel position on puncture pain and postremoval bleeding time in hemodialysis patients: A self-controlled, single-blind study. Hemodial Int. 2022 Oct;26(4):503-508. doi: 10.1111/hdi.13044. Epub 2022 Sep 6.

Reference Type RESULT
PMID: 36068183 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AIN Transfer for Cubital Tunnel Syndrome
NCT05242302 COMPLETED PHASE1/PHASE2