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

NCT06683495 | Completed

• 1 other identifier: 2025
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Chronic; Fistula; Hemodialysis Complication

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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.

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

Study Arms (2)

Mirror Therapy

EXPERIMENTAL

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

Routine Therapy

NO INTERVENTION

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

Interventions

Mirror Therapy OTHER

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

Mirror Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 37615173 RESULT

• 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

• 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.

  PMID: 36068183 RESULT

MeSH Terms

Conditions

Chronic Pain; Fistula

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Nurten Ozen, Assoc.Prof

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: January 5, 2025
• Primary Completion: April 5, 2025
• Study Completion: May 5, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)