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

Primary Purpose

Arteriovenous Fistula

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Study Group
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arteriovenous Fistula focused on measuring Virtual Reality Glasses, Nursing, Pain, Patient Satisfaction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mersin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Glasses Group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood pressure
systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
Heart rate
beats per minute
respiratory rate
ekspiration and inspiration per minute
peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood

Full Information

First Posted
March 25, 2022
Last Updated
April 5, 2022
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT05326321
Brief Title
Effect of Virtual Reality Glasses in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction
Official Title
Effect of Virtual Reality Headset Glasses Used in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
January 9, 2019 (Actual)
Study Completion Date
January 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula
Keywords
Virtual Reality Glasses, Nursing, Pain, Patient Satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel, two-arm, randomized controlled clinical trial
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Glasses Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Study Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain evaluated using the Visual Analog Scale
Description
The patient marks a value between 1 and 10 on the Visual Analog Scale (VAS). As the value increases, the severity of pain increases.
Time Frame
Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Secondary Outcome Measure Information:
Title
Blood pressure
Description
systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
Time Frame
Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Title
Heart rate
Description
beats per minute
Time Frame
Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Title
respiratory rate
Description
ekspiration and inspiration per minute
Time Frame
Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Title
peripheral oxygen saturation
Description
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Time Frame
Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Şen, Master
Organizational Affiliation
Pozantı State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mersin University
City
Mersin
ZIP/Postal Code
33110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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