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

NCT ID: NCT05326321

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-13
• Study Completion Date: 2019-01-09

Brief 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.

Detailed 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.

Conditions

Arteriovenous Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Glasses 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. After the AVF cannulation procedure was completed and 10 minutes later, the VAS and Hemodynamic Variables Follow-up Form were reapplied, and the 2nd and 3rd measurements were obtained. Patients' satisfaction was measured with VAS 10 minutes after the procedure. During the application of virtual reality glasses, a screen was pulled between the patients in the intervention and control groups so that there would be no interaction.

Group Type: EXPERIMENTAL

Study Group

Intervention Type: OTHER

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.

Control group

Without any application to the patients in the control group, the AVF cannulation procedure before HD was performed with the constant site-area puncture technique used by the clinic (after the patient was placed in the fowler position, the arterial needle was 3 cm away from the anastomosis at an angle of 20°-45° towards the distal, and the venous needle was from the arterial needle. 3-5 cm more proximal, again at an angle of 20°-45°) was performed by the HD nurse. The 1st, 2nd and 3rd measurements were obtained as in the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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
• İn 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Didem Lafci

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Şen, Master

Role: PRINCIPAL_INVESTIGATOR

Pozantı State Hospital

Locations

Mersin University

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Mersin Universi

Identifier Type: -

Identifier Source: org_study_id