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

NCT05326321 | Completed

• 1 other identifier: Mersin Universi
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistula

Keywords

Virtual Reality Glasses; Nursing; Pain; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Blood pressure

  Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)

• Heart rate

  Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)

• respiratory rate

  Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)

• peripheral oxygen saturation

  Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)

Study Arms (2)

Virtual Reality Glasses Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Study Group 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.

Virtual Reality Glasses Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, 33110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hatice Şen, Master

  Pozantı State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: According to the randomization table, the information showing the patients included in the research sample is assigned to the A and B groups will be put in an opaque envelope. This envelope will be kept by the coordinator researcher (DL) and when the researcher (HŞ) goes to the patient for application, after filling out the "Informed Voluntary Consent Form", he will open the envelope and learn which group is in which group. Due to the nature of the study, patients and the researcher (HŞ) will not be blinded, since abdominal massage will be applied only to the patients included in the study. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups, and the data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will be blind to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Prospective, parallel, two-arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 13, 2022
• Study Start: November 13, 2018
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)