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

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

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.

Study Overview

• Status: Completed
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Other: Study Group

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mersin, Turkey, 33110
    • Mersin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Heart rate	beats per minute	Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
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)
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)

Collaborators and Investigators

• Sponsor: Mersin University
• Investigators: Principal Investigator: Hatice Şen, Master, Pozantı State Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2018
• Primary Completion (ACTUAL): January 9, 2019
• Study Completion (ACTUAL): January 9, 2019

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (ACTUAL): April 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Nursing; Patient Satisfaction; Virtual Reality Glasses
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: Mersin Universi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No