The Efficacy of VR and AR on Pruritus

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT04289038

Collaborator

Baskent University (Other)

Enrollment

Location

Arms

10.9

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Insufficiency Pruritus Itch	Other: Autogenic Relaxation Other: virtual reality game application Other: kidney function narration	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Feb 26, 2022

Actual Study Completion Date :

Feb 26, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neşe Altinok Ersoy	Ankara	Eyalet/Yerleşke	Turkey	06100

Sponsors and Collaborators

Hacettepe University
Baskent University

Investigators

Principal Investigator: NEŞE ALTINOK ERSOY, PHDC, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neşe Altinok Ersoy, MS, Research Assistant, Principal Investigator, Hacettepe University

ClinicalTrials.gov Identifier:

NCT04289038

Other Study ID Numbers:

KA180157

First Posted:

Feb 28, 2020

Last Update Posted:

Mar 15, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Neşe Altinok Ersoy, MS, Research Assistant, Principal Investigator, Hacettepe University

Additional relevant MeSH terms:

Renal Insufficiency

Renal Insufficiency, Chronic

Pruritus

Study Results

No Results Posted as of Mar 15, 2022