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Completed

NCT Number: NCT04289038

The Efficacy of VR and AR on Pruritus

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

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Key information

Conditions

Chronic Renal Insufficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Itch Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pruritus Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neşe Altinok Ersoy

Ankara, Eyalet/Yerleşke, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autogenic Relaxation

Other

Autogenic relaxation

virtual reality game application

Other

virtual reality game application,

kidney function narration

Other

kidney function narration

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Baskent University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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