Clinical trial NCT06683495: Effect of Mirror Therapy on the Arteriovenous Fistula Cannulation-related Pain and Anxiety
Official title: Effect of Mirror Therapy on the Arteriovenous Fistula Cannulation-related Pain and Anxiety: A Prospective, Single Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Fistula
Hemodialysis Complication
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline Fistula Cannulation Related Pain
timeFrame: Up to 2 weeks (3 hemodialysis sessions in a week)
measure: Change From Baseline Anxiety at Six Sessions
timeFrame: Up to 2 weeks ( 3 hemodialysis sessions in a week)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Nurten Ozen, Assoc.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.