Response Of Arteriovenous Fistula Puncture-related Pain To Cryotherapy Application In Haemodialysis Patients

Overview

Kidney disease occurs when kidney reduces its normal function, less than 30% of normal activity is related to a long-term condition. Therefore, people need to participate in a haemodialysis (HD) programme. In HD, blood is filtered by an external machine, done about three times a week and the access is gained through intermittent vascular cannulation. The patients experience considerable pain due to the frequent insertion of AVF catheters. Hemodialysis patients experience anxiety before needle insertion due to repeated punctures, and over 90% of patients experience acute pain during the process. Puncture-related pain during arteriovenous fistula (AVF) cannulation in particular is a crucial influential factor in quality of life. Cryotherapy is one of the interventions used in several studies to alleviate the arteriovenous fistula puncture-related pain. It can be conduct by using ice packs and the results of the previous studies have also shown its positive effects on the relief of the fistula puncture-related pain in these patients.

Detailed description

Ninety male and female patients with end stage renal disease randomly assigned into three equal groups (n=30) their ages ranged between 30-50:

1. Group A (30 patients) receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. 2. Group B (30 patients) receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. 3. Group C (30 patients) it is a control group this group not received ice pack.

Interventions

• Other Ice packs (cryotherapy)
  One group of patients receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. The second group of patients receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.

Primary outcome measures

• Visual analogue scale (VAS): [Time frame: Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions]

Secondary outcome measures (2)

• The Arm Motor Ability Test (AMAT) [Time frame: The Arm Motor Ability Test (AMAT): it is measured at baseline, and it will be measured again immediately after 20 sessions.]
• Hospital Anxiety and Depression Scale (HADS): [Time frame: Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.]

Eligibility criteria

Inclusion criteria

• The study includes patients with ages from 30 to 50 years.
• Patients able to report pain adequately.
• Patients with end-stage kidney failure undergoing regular hemodialysis who have been treated for more than 3 months, at least twice per week, with arteriovenous fistula in use for more than 1 month are included in the study.

Exclusion criteria

Patients with conditions such as

• advanced age,
• advanced diabetes,
• cardiovascular insufficiency,
• cold allergy,
• Reynaud's phenomenon,
• nerve and tissue damage,
• fractures,
• heart failure,
• uncooperative patients,
• cognitive impairment preventing a proper assessment of pain.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Cairo university — Cairo

Identifiers

NCT: NCT06520631 · P.T.REC/012/005168

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗