Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588114
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Arteriovenous Fistula Cannulation Pain and Skin Cooling Device
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HD patients
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 Scaleamp34 will be used to determine the pain severity of hemodialysis patients before and after arteriovenous fistula intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None