NCT04289038

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2022

Completed
Last Updated

March 15, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

January 16, 2020

Last Update Submit

February 28, 2022

Conditions

Chronic Renal InsufficiencyPruritusItch

Keywords

itchpruritusnursingvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 5-D Itch Scale

    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 Outcomes (2)

  • Dermatology Life Quality Index

    Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .

  • State-Trait Anxiety Inventory

    Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.

Study Arms (3)

Autogenic Relaxation

EXPERIMENTAL

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

Other: Autogenic Relaxation

Virtual Reality

EXPERIMENTAL

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

Other: virtual reality game application

Control Group

OTHER

Routine nursing care and kidney function narration

Other: kidney function narration

Interventions

Autogenic RelaxationOTHER

Autogenic relaxation

Autogenic Relaxation
virtual reality game applicationOTHER

virtual reality game application,

Virtual Reality
kidney function narrationOTHER

kidney function narration

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving hemodialysis treatment for the last 6 months,
  • Receiving four hour hemodialysis treatment three times a week,
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neşe Altinok Ersoy

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

Location

Related Publications (1)

  • Altinok Ersoy N, Akyar I, Yildirim T, Erdogmus S. Effects of a Virtual Reality Game or Autogenic Relaxation on Pruritus, Anxiety and Dermatologic Quality of Life in Haemodialysis Patients: A Randomized Controlled Trial. Int J Nurs Pract. 2025 Oct;31(5):e70071. doi: 10.1111/ijn.70071.

    PMID: 41069201DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicPruritus

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • NEŞE ALTINOK ERSOY, PHDC

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS, Research Assistant, Principal Investigator

Study Record Dates

First Submitted

January 16, 2020

First Posted

February 28, 2020

Study Start

April 1, 2021

Primary Completion

February 26, 2022

Study Completion

February 26, 2022

Last Updated

March 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)