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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

advanced age,

advanced diabetes,

cardiovascular insufficiency,

cold allergy,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ice packs (cryotherapy)

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Cryotherapy to arteriovenous fistula puncture siteActive comparator 1 intervention
Group B: Cryotherapy to site opposite to arteriovenous fistula puncture siteActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

The Arm Motor Ability Test (AMAT)

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

Time frame
The Arm Motor Ability Test (AMAT): it is measured at baseline, and it will be measured again immediately after 20 sessions.
2

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.

Time frame
Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.

Other outcomes

Sponsors and contacts

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