Clinical trial NCT06588114: Arteriovenous Fistula Cannulation Pain and Skin Cooling Device
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease on Hemodialysis
Keywords: Hemodialysis
Arteriovenous fistula
Valsalva
Antistress ball
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
Collaborators: name: Gümüşhane Universıty
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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\&amp;#34; will be used to determine the pain severity of hemodialysis patients before and after arteriovenous fistula intervention.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Experimental group (skin cooling) The Pain Catastrophization Scale
timeFrame: 4 week
measure: Experimental (Skin cooling) Pain (Visual Analogue Pain Scale)
timeFrame: 4 week
measure: Experimental (The valsalva maneuver group)The pain catastrophizing scale
timeFrame: 4 week
measure: Experimental (The valsalva maneuver group) Pain (Visual Analogue Pain Scale)
timeFrame: 4 week
measure: Experimental group (Antistress ball group) The Pain Catastrophization Scale
timeFrame: 4 week
measure: Experimental (Antistress ball group) Pain (Visual Analogue Pain Scale)
timeFrame: 4 week
measure: Control group The Pain Catastrophization Scale
timeFrame: 4 week
measure: Control Group Pain (Visual Analogue Pain Scale)
timeFrame: 4 week
Secondary outcomes:
measure: Experimental(Skin cooling) Pain (Visual Analogue Pain Scale)
timeFrame: 8 week
measure: Experimental (Skin cooling) The Pain Catastrophization Scale
timeFrame: 8 week
measure: Experimental group (Valsalva Maneuver Group) Visual Analog Pain Scale
timeFrame: 8 week
measure: Experimental (The valsalva maneuver group) The Pain Catastrophization Scale
timeFrame: 8 week
measure: Experimental(Antistress ball group) Pain (Visual Analogue Pain Scale)
timeFrame: 8 week
measure: Experimental (Antistress ball group) The Pain Catastrophization Scale
timeFrame: 8 week
measure: Control Group Pain (Visual Analogue Pain Scale)
timeFrame: 8 week
measure: Control group The Pain Catastrophization Scale
timeFrame: 8 week
Other outcomes:
Locations:
city: Kelkit
country: Turkey
facility: Kelkit State Hospital
state: Gumushane
Study officials:
affiliation: Gümüşhane Universıty
name: AYNUR CIN, DR
role: PRINCIPAL_INVESTIGATOR
References: