CClinicalTrials.gg
CompletedNCT06683495Updated May 9, 2025

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

An interventional study of Mirror Therapy in Pain, Chronic, Fistula and Hemodialysis Complication, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-09.

Sponsored by Istanbul University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Pain, Chronic
  • Fistula
  • Hemodialysis Complication
03

In context

Arteriovenous Fistula

267 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

This study's enrollment of 54 is below the median of 68 across 177 interventional studies indexed under Arteriovenous Fistula.

Browse Arteriovenous Fistula studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    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.

    Other: Mirror Therapy

  • No intervention
    Routine Therapy

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

Interventions

  • OtherMirror Therapy

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

06

What researchers measure

Primary outcomes

  1. Change From Baseline Fistula Cannulation Related Pain

    It will be assessed six times at the end of the dialysis session with Visual Analogue Scale. Visual Analogue Scale ranging from 0 (no pain) to 10 (worst pain). Pain increases the score increases. The high point describes bad outcome

    Time frame: Up to 2 weeks (3 hemodialysis sessions in a week)

  2. Change From Baseline Anxiety at Six Sessions

    It will be assessed with State-Trait Anxiety Inventory. This scale, which has a two-factor structure is comprised of 40 items. Twenty of these items assess the state anxiety status and the other 20 items assess trait anxiety. Each item is scored on a four-point scale. Total score ranges between 20 and 80 for anxiety. A high score indicates a high level of anxiety.

    Time frame: Up to 2 weeks ( 3 hemodialysis sessions in a week)

07

Study locations

1 site
  • Istanbul University
    Istanbul, Turkey
08

References and documents

Publications

  • 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. PubMed 37615173 ↗
  • 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. PubMed 31797508 ↗
  • 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. PubMed 36068183 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06683495
Lead sponsor
Istanbul University
Responsible party
Nurten Ozen (Associate Professor, Istanbul University) — Principal investigator
First posted
Nov 12, 2024
Start date
Jan 5, 2025
Primary completion
Apr 5, 2025
Completion
May 5, 2025
Last update
May 9, 2025

Study contacts

Nurten Ozen, Assoc.Prof
principal investigator · Istanbul University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion