The Efficacy of VR and AR on Pruritus

Not Applicable

Completed

• Conditions: Chronic Renal Insufficiency; Pruritus; Itch
• Interventions: Other: kidney function narration; Other: Autogenic Relaxation; Other: virtual reality game application

• Registration Number: NCT04289038
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Study Start: 2021-04-01
• Status Verified: 2022-02
• Primary Completion: 2022-02-26
• Study Completion: 2022-02-26
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
5-D Itch Scale	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Neşe Altinok Ersoy; 🇹🇷 Ankara, Eyalet/Yerleşke, Turkey