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

Cairo University (CU)

Status: Enrolling

Conditions: Hemodialysis Complication

Treatments: Other: Ice packs (cryotherapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT06520631

P.T.REC/012/005168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Cryotherapy to arteriovenous fistula puncture site

Active Comparator group

Description:

This 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.

Treatment:

Other: Ice packs (cryotherapy)

Cryotherapy to site opposite to arteriovenous fistula puncture site

Active Comparator group

Description:

This 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.

Treatment:

Other: Ice packs (cryotherapy)