Chronic Renal InsufficiencyNCT04289038
The Efficacy of VR and AR on Pruritus
A study testing Autogenic Relaxation, virtual reality game application and kidney function narration in people with Chronic Renal Insufficiency and Pruritus, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The research will be conducted randomly in order to determine the effect of VR and AR on pruritus symptom. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Insufficiency, Pruritus, Itch
- What is being tested?
- Autogenic Relaxation, virtual reality game application and kidney function narration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 26 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Neşe Altinok Ersoy
Ankara, Eyalet/Yerleşke, 06100
About this study
Official title: Evaluation of the Efficacy of VR and AR on Pruritus Symptoms in Patients Receiving Hemodialysis Treatment
The research will be conducted randomly in order to determine the effect of VR and AR on pruritus symptom.
Read the 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.
- Conditions
- Chronic Renal Insufficiency, Pruritus, Itch
- Being tested
- Autogenic Relaxation, virtual reality game application, kidney function narration
- Keywords
- itch, pruritus, nursing, virtual reality
- Medical subject headings
- Renal Insufficiency, Chronic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic RelaxationOther
Autogenic relaxation
virtual reality game applicationOther
virtual reality game application,
kidney function narrationOther
kidney function narration
| Study group | Role | What they receive |
|---|---|---|
| Autogenic Relaxation | Experimental | Autogenic Relaxation: It is an exercise program consisting of standard sentences that describe the body's absolute comfort and calm features. Receives: Other: Autogenic Relaxation |
| Virtual Reality | Experimental | Virtual reality: Playing games via smart phone with virtual reality glasses and headset. Receives: Other: virtual reality game application |
| Control Group | Other | Routine nursing care and kidney function narration Receives: Other: kidney function narration |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-D Itch Scale
The score obtained from information about itching severity, frequency, and its effect on daily life activities.
Measured: Assessing change of 5-D Itch Scale scores baseline, first, fifth and seventh weeks.
Secondary outcomes (2)
Dermatology Life Quality Index
The scale gives an information about quality of life
Measured: Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .
State-Trait Anxiety Inventory
The scale gives an information about anxiety
Measured: Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Apr 2021
- Primary completion26 Feb 2022
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Neşe Altinok Ersoy, Hacettepe University
- Investigators
- NEŞE ALTINOK ERSOY, PHDC, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289038
- Sponsor's protocol ID
- KA180157
- Status last verified
- Feb 2022
- First submitted
- 16 Jan 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41069201
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of VR and AR on Pruritus Symptoms in Patients Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT04289038
- Acronym / sponsor ID
- KA180157
- Conditions
- Chronic Renal Insufficiency, Pruritus, Itch
- Keywords
- itch, pruritus, nursing, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autogenic Relaxation | Experimental | Other: Autogenic RelaxationAutogenic Relaxation: It is an exercise program consisting of standard sentences that describe the body's absolute comfort and calm features. |
| Virtual Reality | Experimental | Other: virtual reality game applicationVirtual reality: Playing games via smart phone with virtual reality glasses and headset. |
| Control Group | Other | Other: kidney function narrationRoutine nursing care and kidney function narration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autogenic RelaxationAutogenic relaxation | Other | Autogenic Relaxation |
| virtual reality game applicationvirtual reality game application, | Other | Virtual Reality |
| kidney function narrationkidney function narration | Other | Control Group |
Primary outcome
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.
2 secondary outcomes
Dermatology Life Quality Index
Time frame: Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .
State-Trait Anxiety Inventory
Time frame: Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 41069201Altinok 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NEŞE ALTINOK ERSOY, PHDC principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenic Relaxation, virtual reality game application and kidney function narration in people with Chronic Renal Insufficiency and Pruritus, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-D Itch Scale (time frame: Assessing change of 5-D Itch Scale scores baseline, first, fifth and seventh weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04289038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.