Arteriovenous Fistula Cannulation Pain and Skin Cooling Device

Официальное название

Antistress Ball Applied to Hemodialysis Patients, Valsalva Maneuver and Pain Due to Arteriovenous Fistula Cannulation of Skin Cooling Device and the Effect of Fear of Pain: a Randomized Controlled Trial

Обзор

To determine the effect of the antistress ball, valsalva maneuver and skin cooling device, which are one of the nonpharmacological methods applied to hemodialysis patients, on the level of pain and fear of pain due to arteriovenous fistula cannulation.

Подробное описание

Patients with chronic renal failure who are being treated with hemodialysis experience pain during invasive intervention with arteriovenous fistula. This condition negatively affects hemodialysis patients and leads to a decrease in their quality of life. In order to reduce the pain and fear experienced during arteriovenous fistula intervention, it is recommended to use pharmacological methods as well as nonpharmacological methods. Antistress ball, which is one of the nonpharmacological methods, reduces pain during arteriovenous fistula intervention by causing distraction in hemodialysis patients, but its effect on fear of pain is not yet known. Of the other nonpharmacological methods, the valsalva maneuver reduces pain during vascular intervention, but the pain and fear of pain during arteriovenous fistula intervention have not yet been investigated. In the same way, the effects of skin cooling device on pain and fear of pain during arteriovenous fistula intervention are unknown. The aim of this randomized controlled trial is to; to determine the effect of the antistress ball, valsalva maneuver and skin cooling device, which are one of the nonpharmacological methods applied to hemodialysis patients, on the level of pain and fear of pain due to arteriovenous fistula cannulation. This study will be conducted in an experimental type and 60 patients receiving hemodialysis treatment at X State Hospital hemodialysis unit will form the sample of the study. All patients in the experimental group will be given nonpharmacological applications (antistress ball, valsalva maneuver and skin cooling application) for 8 weeks, three times a week. The control group will not be given any intervention and will receive routine treatment. The 'Pain Catastrophization Scale' will be applied to the experimental and control groups before, in the middle and after the research. The 'Visual Analog Pain Scale\" will be used to determine the pain severity of hemodialysis patients before and after arteriovenous fistula intervention.

Вмешательства

• Другое Antistress Ball
  Hemodialysis patients will be asked to look away by giving an antistress ball to the non-arteriovenous fistula hand and squeezing and then loosening the ball during the arteriovenous fistula intervention
• Другое The Valsalva maneuver
  The Valsalva maneuver is a breathing method that can slow down a heart with a very fast pulse rate. In this maneuver, the individual breathes strongly through his mouth while his nose is tightly closed, and while holding his breath, a strong tension occurs. This maneuver allows the heart to react and return to a normal rhythm.
• Другое Skin cooling
  Hemodialysis patients will be provided with lowering of skin temperature with a skin cooling device by the researcher for 10 minutes before arteriovenous fistula intervention is made to hemodialysis patients

Первичные конечные точки

• Experimental group (skin cooling) The Pain Catastrophization Scale [Срок оценки: 4 week]
• Experimental (Skin cooling) Pain (Visual Analogue Pain Scale) [Срок оценки: 4 week]
• Experimental (The valsalva maneuver group)The pain catastrophizing scale [Срок оценки: 4 week]
• Experimental (The valsalva maneuver group) Pain (Visual Analogue Pain Scale) [Срок оценки: 4 week]
• Experimental group (Antistress ball group) The Pain Catastrophization Scale [Срок оценки: 4 week]
• Experimental (Antistress ball group) Pain (Visual Analogue Pain Scale) [Срок оценки: 4 week]
• Control group The Pain Catastrophization Scale [Срок оценки: 4 week]
• Control Group Pain (Visual Analogue Pain Scale) [Срок оценки: 4 week]

Вторичные конечные точки (8)

• Experimental(Skin cooling) Pain (Visual Analogue Pain Scale) [Срок оценки: 8 week]
• Experimental (Skin cooling) The Pain Catastrophization Scale [Срок оценки: 8 week]
• Experimental group (Valsalva Maneuver Group) Visual Analog Pain Scale [Срок оценки: 8 week]
• Experimental (The valsalva maneuver group) The Pain Catastrophization Scale [Срок оценки: 8 week]
• Experimental(Antistress ball group) Pain (Visual Analogue Pain Scale) [Срок оценки: 8 week]
• Experimental (Antistress ball group) The Pain Catastrophization Scale [Срок оценки: 8 week]
• Control Group Pain (Visual Analogue Pain Scale) [Срок оценки: 8 week]
• Control group The Pain Catastrophization Scale [Срок оценки: 8 week]

Критерии участия

Критерии включения

• be 18 years of age or older
• Volunteering to participate in the study
• Being a hemodialysis patient and being on hemodialysis for more than three months
• Having an arteriovenous fistula that has been used for more than a month
• To be hemodialyzed three times a week
• To be literate
• Absence of communication barrier
• Not having any psychiatric diagnosis
• Not having cognitive impairment

Критерии исключения

• being under the age of 18
• It takes less than a month for the arteriovenous fistula to be newly opened
• Having a different type of vascular interference from arteriovenous fistula
• Having phlebitis, scar tissue, dermatitis, an incision or infection at the site of arteriovenous interference
• Hemodialysis of the patient more or less than three times a week
• Having any disease that may affect the perception of pain
• Illiteracy
• Having a psychiatric diagnosis
• Having any discomfort in the hand and arm that allows squeezing the antistress ball
• There is a communication barrier
• Having a cognitive impairment

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

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Kelkit State Hospital — Kelkit

Идентификаторы

NCT: NCT06588114 · E-95674917-108.99-248196

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗