The Efficacy of VR and AR on Pruritus

February 28, 2022 updated by: Neşe Altinok Ersoy, Hacettepe University

Evaluation of the Efficacy of VR and AR on Pruritus Symptoms in Patients Receiving Hemodialysis Treatment

The research will be conducted randomly in order to determine the effect of VR and AR on pruritus symptom.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Eyalet/Yerleşke
      • Ankara, Eyalet/Yerleşke, Turkey, 06100
        • Neşe Altinok Ersoy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Autogenic Relaxation
Autogenic Relaxation: It is an exercise program consisting of standard sentences that describe the body's absolute comfort and calm features.
Other: Autogenic Relaxation
Autogenic relaxation
EXPERIMENTAL: Virtual Reality
Virtual reality: Playing games via smart phone with virtual reality glasses and headset.
Other: virtual reality game application
virtual reality game application,
OTHER: Control Group
Routine nursing care and kidney function narration
Other: kidney function narration
kidney function narration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-D Itch Scale
Time Frame: Assessing change of 5-D Itch Scale scores baseline, first, fifth and seventh weeks.
The score obtained from information about itching severity, frequency, and its effect on daily life activities.
Assessing change of 5-D Itch Scale scores baseline, first, fifth and seventh weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatology Life Quality Index
Time Frame: Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .
The scale gives an information about quality of life
Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .
State-Trait Anxiety Inventory
Time Frame: Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.
The scale gives an information about anxiety
Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Baskent University

Investigators

  • Principal Investigator: NEŞE ALTINOK ERSOY, PHDC, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

February 26, 2022

Study Completion (ACTUAL)

February 26, 2022

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA180157

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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