Effect of Virtual Reality Glasses in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction

Arteriovenous Fistula Clinical Trial

Official title:

Effect of Virtual Reality Headset Glasses Used in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326321
• Other study ID #: Mersin Universi
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: January 9, 2019

Study information

• Verified date: April 2022
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research was conducted as a randomized controlled experimental study aiming to determine the impact of virtual reality glasses used in the AVF process on the pain felt by patients and patient satisfaction.

Description:

Chronic kidney disease (CKD) is a progressive, irreversible renal disease in which the ability of the body to maintain the balance of metabolism, fluid and electrolytes fails. Chronic kidney disease (CKD) is one of the major health problems with an increasing prevalence in the World. Hemodialysis as one of the most common methods of renal replacement therapy is a stressful procedure despite to maintain the survival of patients with chronic kidney disease that permanent and safe vascular access is one of the requirements of a successful hemodialysis. The pain of AVF puncture is common among the patients undergoing HD as acute and chronic pain which reported in more than 82% and 92% of them, respectively. Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Receiving HD treatment
• Open to communication
• Fully oriented
• Without vision, hearing and perception problems
• Without any psychiatric illness
• Without a history of seizures such as epilepsy
• HD treatment administered via AVF
• In the last day, no injection was made into any artery or vein from the place where the intervention will be performed
• Without any signs of infection such as redness, swelling, open wound in the area where the intervention will be performed
• Standardized Mini Mental Test value is 24 points and above
• One-time needle attempt from AV

Exclusion Criteria:

• Refusing to participate in the study
• under the age of 18
• Can't speak Turkish
• Closed to communication and not fully oriented
• Visual, hearing and perception problems
• Any psychiatric illness
• Having a history of seizures such as epilepsy
• HD treatment not administered via AVF
• Injection into any artery or vein from the place where the intervention will be performed in the last day,
• Any signs of infection such as redness, swelling, open wound in the area to be operated
• Using any pain medication before the procedure on the same day
• SMMT value below 24 in patients over 65 years of age
• Cannulation procedure not performed with a 16 G AVF needle
• Patients with multiple injections from the AVF

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Other:
• Study Group
The patients in the intervention group were shown a video with virtual reality glasses for an average of 5 minutes, 2 minutes before the start of the AVF cannulation procedure and 3 minutes throughout the procedure.

Locations

Country	Name	City	State
Turkey	Mersin University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain evaluated using the Visual Analog Scale	The patient marks a value between 1 and 10 on the Visual Analog Scale (VAS). As the value increases, the severity of pain increases.	Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Secondary	Blood pressure	systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg	Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Secondary	Heart rate	beats per minute	Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Secondary	respiratory rate	ekspiration and inspiration per minute	Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Secondary	peripheral oxygen saturation	%, percentage of oxygenated hemoglobin in peripheral arterial blood	Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)