Clinical trial NCT06520631: Response Of Arteriovenous Fistula Puncture-related Pain To Cryotherapy Application In Haemodialysis Patients
Official title: Response Of Arteriovenous Fistula Puncture-related Pain To Cryotherapy Application In Haemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale (VAS):
timeFrame: Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions
Secondary outcomes:
measure: The Arm Motor Ability Test (AMAT)
timeFrame: The Arm Motor Ability Test (AMAT): it is measured at baseline, and it will be measured again immediately after 20 sessions.
measure: Hospital Anxiety and Depression Scale (HADS):
timeFrame: Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Nagwa Mohamed Badr, Professor
role: STUDY_DIRECTOR
affiliation: Cairo university El-kasr el-aini
name: Sahier Omar El-khashab, Professor
role: STUDY_DIRECTOR
References: