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

NCT06520631 | Recruiting

• 1 other identifier: P.T.REC/012/005168
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (2)

Cryotherapy to arteriovenous fistula puncture site

ACTIVE COMPARATOR

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)

Cryotherapy to site opposite to arteriovenous fistula puncture site

ACTIVE COMPARATOR

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)

Interventions

Ice packs (cryotherapy) OTHER

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.

Cryotherapy to arteriovenous fistula puncture site; Cryotherapy to site opposite to arteriovenous fistula puncture site

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 11432, Egypt

RECRUITING

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nagwa Mohamed Badr, Professor

  Cairo University

  STUDY DIRECTOR

• Sahier Omar El-khashab, Professor

  Cairo university El-kasr el-aini

  STUDY DIRECTOR

Central Study Contacts

Sara Fathy El-said, Physical therapist

CONTACT

01205692600; saraghoneem581@gmail.com

Alaa Mohamed El-moatasem, Lecturer

CONTACT

01006625054; alaamotasem@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 25, 2024
• Study Start: May 4, 2024
• Primary Completion: August 24, 2024
• Study Completion: August 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

EG (1)