Hemodialysis, Virtual RealityHemodialysisNCT07281144
Effect of Virtual Reality on Cannulation-Related Procedural Pain, Distress and Comfort Level in Hemodialysis Patients
A study testing Virtual Reality in people with Hemodialysis, Virtual Reality, run by Tarsus University at 2 sites in Turkey (Türkiye).
Trial summary
This study aimed to determine the effects of virtual reality on procedural pain, distress and comfort levels during cannulation in hemodialysis patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Virtual Reality
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 25 Dec 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients aged 18 years and older
- who had been receiving hemodialysis treatment via AVF for four-hour sessions three times per week for at least six months
- had a pain score of 0 according to the VAS before the procedure
- were not using any psychiatric medicatio
- voluntarily agreed to participate in the study
Who cannot join
- Patients were excluded if they had a diagnosed mental health disability,
- language barriers
- were using analgesic drugs within eight hours prior to the hemodialysis session
- a history of epilepsy, vertigo, anxiety, active nausea, vomiting, or headaches
- regular use of painkillers
- chronic pain disorders
- previous experience with virtual reality.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
School
Mersin, Health Sciences Faculty , Tarsus University, Mersin, Turkey, 33400
Tarsus U
Tarsus, Tarsus, 33400
About this study
Official title: Effect of Virtual Reality on Cannulation-Related Procedural Pain, Distress and Comfort Level in Hemodialysis Patients: A Randomized Controlled Study
This study aimed to determine the effects of virtual reality on procedural pain, distress and comfort levels during cannulation in hemodialysis patients.
Read the detailed description
Background Virtual reality is a non-pharmacological method that reduces pain and distress and increases comfort by diverting a patient's attention. This allows individuals to gain self-control and relax during medical procedures.
Purpose: This study aimed to determine the effects of virtual reality on procedural pain, distress and comfort levels during cannulation in hemodialysis patients.
Methods: This randomized controlled study included a total of 52 patients, who were randomly assigned to either the intervention group (n=26) or the control group (n=26). Patients in the intervention group received virtual reality glasses during the procedure in addition to standard routine care, while the control group received standard routine care only. Data were collected using a Descriptive Information Form, the Visual Analogue Scale (VAS), the Distress Thermometer (DT), and the Hemodialysis Comfort Scale. Statistical analysis was performed with the level of significance set at p<0.05.
- Conditions
- Hemodialysis, Virtual Reality
- Being tested
- Virtual Reality
- Keywords
- Arteriovenous fistula, Cannulation, Distress, Hemodialysis, Procedural pain, Virtual reality
- Medical subject headings
- Arteriovenous Fistula, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
The intervention utilized VR-SHINECON and headsets, which were cleaned with alcohol-based disinfectant wipes before use for each patient (Figure 1). Patients in the intervention group were offered a choice of various nature, forest, and seaside walk videos with thematic music. The VR intervention commenced approximately three minutes before the cannulation procedure (immediately following the baseline assessment) and continued until the procedure was complete (approx. 5-10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The routine cannulation procedure was applied to the patients in the control group. Apart from this, no additional intervention was implemented. Each patient's pain was evaluated and recorded by a nurse independent of the study during the procedure (1st measurements) with VAS and after the procedure (2st measurements). Similarly, the patient's distress was evaluated with Distress Thermometer and recorded before (1st measurements) and after the procedure (2st measurements) by a nurse independent of the study. HDCS of the patients were evaluated and recorded and immediately after the procedure was completed. |
| Virtual Reality | Experimental | The intervention utilized VR-SHINECON and headsets, which were cleaned with alcohol-based disinfectant wipes before use for each patient. Patients in the intervention group were offered a choice of various nature, forest, and seaside walk videos with thematic music. The VR intervention commenced approximately three minutes before the cannulation procedure and continued until the procedure was complete. During the procedure, the patient's pain was evaluated and recorded by an independent nurse (referred to as the 1st measurement).Immediately after the procedure was completed, the patient removed the VR glasses. The Visual analogue scale, DT and Hemodialysis Comfort Scale were then assessed and recorded by the independent nurse (referred to as the 2nd measurements). Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
The data were collected by the researcher by using "Descriptive Information Form"
Descriptive information form This form prepared by the researchers after reviewing relevant literature (18,21), this semi-structured form includes 12 questions focusing on the socio-demographic and medical information of the participants.
Measured: The descriptive information form was completed in the patient's room 15-20 minutes before the cannulation procedure.
Visual Analogue Scale
This scale (VAS), originally developed by Price et al.22 and validated in Turkish for postoperative pain assessment by Eti Aslan 23, was used to quantify pain intensity. The scale consists of a 10-cm horizontal line anchored by the descriptors "no pain" and "worst imaginable pain". Participants marked their perceived pain level on the line, and the score was recorded in centimeters. Written permission for the Turkish version was secured from Eti Aslan. All VAS measurements were recorded by an independent nurse who was not involved in the intervention.
Measured: During the procedure, the patient's pain was evaluated and recorded by an independent nurse (referred to as the 1st measurement). Immediately after the procedure was completed, after an average of 1-2 minutes (VAS were then assessed (2st measurement).
Distress Thermometer
The Distress Thermometer was first developed by Roth and colleagues for use in identifying non-pathological distress in patients undergoing cancer treatment after answering the necessary questions. The distress level is rated from 0 to 10. The practitioner expresses the distress experienced using the numbers on the thermometer. A score of zero indicates no distress, while a score of 10 indicates the highest level of distress. The green zone encompasses scores from 0 to 3. Individuals experiencing distress within this range are capable of managing their distress. The yellow zone encompasses scores from 4 to 6. A distress score in this range indicates that the individual is unable to manage their distress and requires intervention to return them to the green zone. The red zone encompasses scores from 7 to 10. Individuals experiencing distress within this range require urgent and comprehensive intervention.
Measured: Before the Procedure and baseline, after the procedure was completed an average of 5-10 minutes(2st measurement)
Hemodialysis Comfort Scale
This scale developed by Şahin Orak et al., is a reliable, nine-item, five-point Likert-type instrument used to assess comfort in patients receiving hemodialysis for at least six months.29 It consists of two subscales: 'Relaxation' and 'Coping.' Items are scored from 1 to 5 with Item 4 being reverse-scored. Total scores range from 9.00 to 45.00, where higher scores indicate greater comfort. Subscale ranges are 3.00-15.00 for Relaxation and 7.00-30.00 for Coping. The scale demonstrated strong reliability, with a Cronbach's alpha of 0.87 in the original Turkish validation study, and 0.80 in the present study.
Measured: after the procedure was completed an average of 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Nov 2024
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis, Virtual RealityStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ezgi mutluay yayla, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281144
- Sponsor's protocol ID
- 2024/106
- Acronym
- Hemodialysis
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Cannulation-Related Procedural Pain, Distress and Comfort Level in Hemodialysis Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07281144
- Acronym / sponsor ID
- Hemodialysis / 2024/106
- Conditions
- Hemodialysis, Virtual Reality
- Keywords
- Arteriovenous fistula, Cannulation, Distress, Hemodialysis, Procedural pain, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 15 Dec 2025 (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.
This study aimed to determine the effects of virtual reality on procedural pain, distress and comfort levels during cannulation in hemodialysis patients.
Detailed description
Background Virtual reality is a non-pharmacological method that reduces pain and distress and increases comfort by diverting a patient's attention. This allows individuals to gain self-control and relax during medical procedures.
Purpose: This study aimed to determine the effects of virtual reality on procedural pain, distress and comfort levels during cannulation in hemodialysis patients.
Methods: This randomized controlled study included a total of 52 patients, who were randomly assigned to either the intervention group (n=26) or the control group (n=26). Patients in the intervention group received virtual reality glasses during the procedure in addition to standard routine care, while the control group received standard routine care only. Data were collected using a Descriptive Information Form, the Visual Analogue Scale (VAS), the Distress Thermometer (DT), and the Hemodialysis Comfort Scale. Statistical analysis was performed with the level of significance set at p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The routine cannulation procedure was applied to the patients in the control group. Apart from this, no additional intervention was implemented. Each patient's pain was evaluated and recorded by a nurse independent of the study during the procedure (1st measurements) with VAS and after the procedure (2st measurements). Similarly, the patient's distress was evaluated with Distress Thermometer and recorded before (1st measurements) and after the procedure (2st measurements) by a nurse independent of the study. HDCS of the patients were evaluated and recorded and immediately after the procedure was completed. |
| Virtual Reality | Experimental | Device: Virtual RealityThe intervention utilized VR-SHINECON and headsets, which were cleaned with alcohol-based disinfectant wipes before use for each patient. Patients in the intervention group were offered a choice of various nature, forest, and seaside walk videos with thematic music. The VR intervention commenced approximately three minutes before the cannulation procedure and continued until the procedure was complete. During the procedure, the patient's pain was evaluated and recorded by an independent nurse (referred to as the 1st measurement).Immediately after the procedure was completed, the patient removed the VR glasses. The Visual analogue scale, DT and Hemodialysis Comfort Scale were then assessed and recorded by the independent nurse (referred to as the 2nd measurements). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- patients aged 18 years and older
- who had been receiving hemodialysis treatment via AVF for four-hour sessions three times per week for at least six months
- had a pain score of 0 according to the VAS before the procedure
- were not using any psychiatric medicatio
- voluntarily agreed to participate in the study
Key exclusion criteria (7 listed)
- Patients were excluded if they had a diagnosed mental health disability,
- language barriers
- were using analgesic drugs within eight hours prior to the hemodialysis session
- a history of epilepsy, vertigo, anxiety, active nausea, vomiting, or headaches
- regular use of painkillers
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 |
|---|---|---|
| Virtual RealityThe intervention utilized VR-SHINECON and headsets, which were cleaned with alcohol-based disinfectant wipes before use for each patient (Figure 1). Patients in the intervention group were offered a choice of various nature, forest, and seaside walk videos with thematic music. The VR intervention commenced approximately three minutes before the cannulation procedure (immediately following the baseline assessment) and continued until the procedure was complete (approx. 5-10 minutes). | Device | Virtual Reality |
Primary outcome
The data were collected by the researcher by using "Descriptive Information Form"
Time frame: The descriptive information form was completed in the patient's room 15-20 minutes before the cannulation procedure.
Descriptive information form This form prepared by the researchers after reviewing relevant literature (18,21), this semi-structured form includes 12 questions focusing on the socio-demographic and medical information of the participants.
Visual Analogue Scale
Time frame: During the procedure, the patient's pain was evaluated and recorded by an independent nurse (referred to as the 1st measurement). Immediately after the procedure was completed, after an average of 1-2 minutes (VAS were then assessed (2st measurement).
This scale (VAS), originally developed by Price et al.22 and validated in Turkish for postoperative pain assessment by Eti Aslan 23, was used to quantify pain intensity. The scale consists of a 10-cm horizontal line anchored by the descriptors "no pain" and "worst imaginable pain". Participants marked their perceived pain level on the line, and the score was recorded in centimeters. Written permission for the Turkish version was secured from Eti Aslan. All VAS measurements were recorded by an independent nurse who was not involved in the intervention.
Distress Thermometer
Time frame: Before the Procedure and baseline, after the procedure was completed an average of 5-10 minutes(2st measurement)
The Distress Thermometer was first developed by Roth and colleagues for use in identifying non-pathological distress in patients undergoing cancer treatment after answering the necessary questions. The distress level is rated from 0 to 10. The practitioner expresses the distress experienced using the numbers on the thermometer. A score of zero indicates no distress, while a score of 10 indicates the highest level of distress. The green zone encompasses scores from 0 to 3. Individuals experiencing distress within this range are capable of managing their distress. The yellow zone encompasses scores from 4 to 6. A distress score in this range indicates that the individual is unable to manage their distress and requires intervention to return them to the green zone. The red zone encompasses scores from 7 to 10. Individuals experiencing distress within this range require urgent and comprehensive intervention.
Hemodialysis Comfort Scale
Time frame: after the procedure was completed an average of 5-10 minutes
This scale developed by Şahin Orak et al., is a reliable, nine-item, five-point Likert-type instrument used to assess comfort in patients receiving hemodialysis for at least six months.29 It consists of two subscales: 'Relaxation' and 'Coping.' Items are scored from 1 to 5 with Item 4 being reverse-scored. Total scores range from 9.00 to 45.00, where higher scores indicate greater comfort. Subscale ranges are 3.00-15.00 for Relaxation and 7.00-30.00 for Coping. The scale demonstrated strong reliability, with a Cronbach's alpha of 0.87 in the original Turkish validation study, and 0.80 in the present study.
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 25 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Hemodialysis, Virtual Reality, run by Tarsus University at 2 sites 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 5 inclusion and 7 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The data were collected by the researcher by using "Descriptive Information Form" (time frame: The descriptive information form was completed in the patient's room 15-20 minutes before the cannulation procedure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.