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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06520631
Enrollment
90
Registered
2024-07-25
Start date
2024-05-04
Completion date
2024-08-31
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Complication

Brief summary

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

OTHERIce 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale (VAS):Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessionsScale to measure the intensity of pain The minimum value is 0 which means no pain and the maximum value is 10 which means the maximum pain

Secondary

MeasureTime frameDescription
The Arm Motor Ability Test (AMAT)The Arm Motor Ability Test (AMAT): it is measured at baseline, and it will be measured again immediately after 20 sessions.The Arm Motor Ability Test (AMAT): is used to assess and quantify upper extremity functional limitation.
Hospital Anxiety and Depression Scale (HADS):Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.Hospital Anxiety and Depression Scale (HADS): it is a reliable and valid tool It's questions are clear and easy to understand, and thought the questionnaire items covered all patients problem areas regarding their hospital anxiety and depression. Each question is scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 means maximum impairment and minimum score of 0 means no impairment for anxiety or depression.

Countries

Egypt

Contacts

Primary ContactSara Fathy El-said, Physical therapist
saraghoneem581@gmail.com01205692600
Backup ContactAlaa Mohamed El-moatasem, Lecturer
alaamotasem@cu.edu.eg01006625054

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026