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The Efficacy of VR and AR on Pruritus

Primary Purpose

Chronic Renal Insufficiency, Pruritus, Itch

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Autogenic Relaxation
virtual reality game application
kidney function narration
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Renal Insufficiency focused on measuring itch, pruritus, nursing, virtual reality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Receiving hemodialysis treatment for the last 6 months,
  • Receiving four hour hemodialysis treatment three times a week,
  • 18-65 years of age,
  • experiencing pruritus for the last month.
  • Not taking any pharmacological / non-pharmacological treatment for pruritus
  • No cognitive and psychiatric diagnosis,
  • Do not use hearing aids,
  • Open to communication and cooperation,
  • Using smart mobile phone,
  • Without liver disease and dermatological diseases,
  • Patients who agree to participate in the study will be included in the study.

Exclusion Criteria:

  • Pregnant in the research process,
  • Kidney transplantation,
  • Experiencing discomfort due to virtual reality glasses,
  • Patients who voluntarily leave the trial will be excluded from the follow-up.

Sites / Locations

  • Neşe Altinok Ersoy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Autogenic Relaxation

Virtual Reality

Control Group

Arm Description

Autogenic Relaxation: It is an exercise program consisting of standard sentences that describe the body's absolute comfort and calm features.

Virtual reality: Playing games via smart phone with virtual reality glasses and headset.

Routine nursing care and kidney function narration

Outcomes

Primary Outcome Measures

5-D Itch Scale
The score obtained from information about itching severity, frequency, and its effect on daily life activities.

Secondary Outcome Measures

Dermatology Life Quality Index
The scale gives an information about quality of life
State-Trait Anxiety Inventory
The scale gives an information about anxiety

Full Information

First Posted
January 16, 2020
Last Updated
February 28, 2022
Sponsor
Hacettepe University
Collaborators
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT04289038
Brief Title
The Efficacy of VR and AR on Pruritus
Official Title
Evaluation of the Efficacy of VR and AR on Pruritus Symptoms in Patients Receiving Hemodialysis Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 26, 2022 (Actual)
Study Completion Date
February 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Baskent 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
The research will be conducted randomly in order to determine the effect of VR and AR on pruritus symptom.
Detailed Description
In this study, there will be three groups: intervention group 1 with autogenic relaxation (AR), intervention group 2 with virtual reality (VR) game application and control group with routine nursing care and kidney functions narration. The number of volunteers to be included in the study was determined by power analysis. Forty patients with itch symptoms will be included in each group. Preliminary application for all three groups will be performed in the patient group registered to the Dialysis Unit of the Nephrology Department of Hacettepe University and Baskent University Hospital. Socio-Demographic Form, 5-D Itch Scale, Dermatology Life Quality Index, State and Trait Anxiety Scale, Pruritus Behavior and SGO / OR Application Log.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Insufficiency, Pruritus, Itch
Keywords
itch, pruritus, nursing, virtual reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autogenic Relaxation
Arm Type
Experimental
Arm Description
Autogenic Relaxation: It is an exercise program consisting of standard sentences that describe the body's absolute comfort and calm features.
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Virtual reality: Playing games via smart phone with virtual reality glasses and headset.
Arm Title
Control Group
Arm Type
Other
Arm Description
Routine nursing care and kidney function narration
Intervention Type
Other
Intervention Name(s)
Autogenic Relaxation
Intervention Description
Autogenic relaxation
Intervention Type
Other
Intervention Name(s)
virtual reality game application
Intervention Description
virtual reality game application,
Intervention Type
Other
Intervention Name(s)
kidney function narration
Intervention Description
kidney function narration
Primary Outcome Measure Information:
Title
5-D Itch Scale
Description
The score obtained from information about itching severity, frequency, and its effect on daily life activities.
Time Frame
Assessing change of 5-D Itch Scale scores baseline, first, fifth and seventh weeks.
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index
Description
The scale gives an information about quality of life
Time Frame
Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .
Title
State-Trait Anxiety Inventory
Description
The scale gives an information about anxiety
Time Frame
Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Receiving hemodialysis treatment for the last 6 months, Receiving four hour hemodialysis treatment three times a week, 18-65 years of age, experiencing pruritus for the last month. Not taking any pharmacological / non-pharmacological treatment for pruritus No cognitive and psychiatric diagnosis, Do not use hearing aids, Open to communication and cooperation, Using smart mobile phone, Without liver disease and dermatological diseases, Patients who agree to participate in the study will be included in the study. Exclusion Criteria: Pregnant in the research process, Kidney transplantation, Experiencing discomfort due to virtual reality glasses, Patients who voluntarily leave the trial will be excluded from the follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NEŞE ALTINOK ERSOY, PHDC
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neşe Altinok Ersoy
City
Ankara
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy of VR and AR on Pruritus

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