ClinicalTrials.Veeva

Menu

Arteriovenous Fistula Cannulation Pain and Skin Cooling Device (HD patients)

K

Karadeniz Technical University

Status

Not yet enrolling

Conditions

Chronic Kidney Disease on Hemodialysis

Treatments

Other: The Valsalva maneuver
Other: Skin cooling
Other: Antistress Ball

Study type

Interventional

Funder types

Other

Identifiers

NCT06588114
E-95674917-108.99-248196

Details and patient eligibility

About

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.

Full 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" will be used to determine the pain severity of hemodialysis patients before and after arteriovenous fistula intervention.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 4 patient groups

experimental group (skin cooler device)
Experimental group
Description:
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.
Treatment:
Other: Skin cooling
experimental group (Antistress Ball Group)
Experimental group
Description:
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.
Treatment:
Other: Antistress Ball
experimental group (Valsalva Maneuver Group)
Experimental group
Description:
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.
Treatment:
Other: The Valsalva maneuver
control group
No Intervention group
Description:
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.

Trial contacts and locations

1

Loading...

Central trial contact

ESRA TANIŞ, STUDENT; AYNUR CIN, DR

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems