Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06520631

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hemodialysis Complication

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

  • 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.
  • 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.
  • Group C (30 patients) it is a control group this group not received ice pack.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Visual analogue scale (VAS):

    Time frame: Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions

    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

Secondary outcomes

  1. 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.

    The Arm Motor Ability Test (AMAT): is used to assess and quantify upper extremity functional limitation.

  2. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Mohamed El-moatasem, Lecturer

CONTACT

[email protected]

01006625054 ext. 01112844076

Sara Fathy El-said, Physical therapist

CONTACT

[email protected]

01205692600 ext. 01149120620

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.