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

Not Applicable

Completed

• Conditions: Pain, Chronic; Fistula; Hemodialysis Complication

• Registration Number: NCT06683495
• Lead Sponsor: Istanbul University

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.

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

Study Timeline

• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Study Start: 2025-01-05
• Primary Completion: 2025-04-05
• Status Verified: 2025-05
• Study Completion: 2025-05-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline Fistula Cannulation Related Pain	Up to 2 weeks (3 hemodialysis sessions in a week)	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
Change From Baseline Anxiety at Six Sessions	Up to 2 weeks ( 3 hemodialysis sessions in a week)	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.

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey