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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Visual analogue scale (VAS): [Срок оценки: Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions]

Вторичные конечные точки (2)

• The Arm Motor Ability Test (AMAT) [Срок оценки: 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): [Срок оценки: Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo university — Cairo

Идентификаторы

NCT: NCT06520631 · P.T.REC/012/005168

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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