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Clinical Trials/NCT04289038
NCT04289038CompletedNot Applicable

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

Hacettepe University1 site in 1 country47 target enrollmentStarted: April 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
47
Locations
1
Primary Endpoint
5-D Itch Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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.

Arms & Interventions

Autogenic Relaxation

Experimental

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

Intervention: Autogenic Relaxation (Other)

Virtual Reality

Experimental

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

Intervention: virtual reality game application (Other)

Control Group

Other

Routine nursing care and kidney function narration

Intervention: kidney function narration (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • State-Trait Anxiety Inventory(Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.)
  • Dermatology Life Quality Index(Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Neşe Altinok Ersoy

MS, Research Assistant, Principal Investigator

Hacettepe University

Study Sites (1)

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