Arteriovenous Fistula Cannulation Pain and Skin Cooling Device

NCT ID: NCT06588114

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease on Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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experimental group (skin cooler device)

Hemodialysis patients in this group will be provided with skin temperature reduction by the researcher with a skin cooling device for 10 minutes before the arteriovenous fistula attempt is made.

Group Type EXPERIMENTAL

Skin cooling

Intervention Type OTHER

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

experimental group (Antistress Ball Group)

Hemodialysis patients in this group 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.

Group Type EXPERIMENTAL

Antistress Ball

Intervention Type OTHER

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

experimental group (Valsalva Maneuver Group)

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. Hemodialysis patients in this group will perform the valsalva maneuver taught to them by the researcher during arteriovenous intervention.

Group Type EXPERIMENTAL

The Valsalva maneuver

Intervention Type OTHER

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.

control group

Hemodialysis patients aged 18 years and older who have arteriovenous fistula and have been on hemodialysis for more than three months will be included in the control group. No intervention will be made to the control group. Patients in this group will receive routine check-ups and hemodialysis treatments.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gümüşhane Universıty

OTHER

Sponsor Role collaborator

Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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AYNUR CİN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AYNUR CIN, DR

Role: PRINCIPAL_INVESTIGATOR

Gümüşhane Universıty

Locations

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Kelkit State Hospital

Kelkit, Gümüşhane Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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AYNUR CIN, DR

Role: CONTACT

4562331053 ext. +905555565187

ESRA TANIŞ, STUDENT

Role: CONTACT

4562331053 ext. 905375692503

Facility Contacts

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FEYZA DALTABAN, DR

Role: primary

4563171450

AYNUR CIN, DR

Role: backup

ESRA TANIS, STUDENT

Role: backup

Other Identifiers

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E-95674917-108.99-248196

Identifier Type: -

Identifier Source: org_study_id

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