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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Other: Ice packs (cryotherapy)

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Fathy El-said, Physical therapist; Phone Number: 01149120620 01205692600; Email: saraghoneem581@gmail.com
• Study Contact Backup: Name: Alaa Mohamed El-moatasem, Lecturer; Phone Number: 01112844076 01006625054; Email: alaamotasem@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Recruiting
    • Cairo University
    • Contact: Alaa Mohamed El-moatasem, Lecturer; Phone Number: 01205692600 01006625054; Email: alaamotasem@cu.edu.eg
    • Contact: Nagwa Mohamed Badr, Professor; Phone Number: 01149120620 01112020504; Email: ngwambadr@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cryotherapy to arteriovenous fistula puncture site; 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.	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.
Active Comparator: Cryotherapy to site opposite to arteriovenous fistula puncture site; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS):	Scale 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	Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Arm Motor Ability Test (AMAT)	The Arm Motor Ability Test (AMAT): is used to assess and quantify upper extremity functional limitation.	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):	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.	Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Nagwa Mohamed Badr, Professor, Cairo University; Study Director: Sahier Omar El-khashab, Professor, Cairo university El-kasr el-aini

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2024
• Primary Completion (Estimated): August 24, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: P.T.REC/012/005168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes