AnxietyPainNCT06776497
The Effect of Video Streaming with Virtual Reality Glasses on Pain and Anxiety
A study testing VIRTUAL REALITY GLASSES (VRG) in people with Anxiety and Pain, run by Selcuk Ozturk at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effect of a video played with VRG during arteriovenous fistula needle insertionon pain and anxiety of patients undergoing haemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- VIRTUAL REALITY GLASSES (VRG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those aged 18 years and older,
- Those who were not pregnant and had no plans to become pregnant,
- Those who had been undergoing HD treatment in HD wards for at least three months and three sessions per week,
- Those who continued dialysis treatment at the same institution,
- Those for whom there were no changes in the treatment programme during the research period,
- Those who had no pain in any part of the body that would affect the study outcome and scored zero on the Visual Analogue Scale for pain at the time of admission,
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- Those who had not taken analgesics in the last 24 hours,
- Those who could understand and communicate in Turkish,
- Those who volunteered to participate in the study and signed the written informed consent form were included in the study.
Who cannot join
- Those who declined to participate in the study,
- Those with a diagnosed neurological disease such as epilepsy, Alzheimer's disease, Parkinson's disease,and Multiple Sclerosis.
- Those with visual and hearing impairments,
- Those who took anxiolytic and/or sedative medications,
- Those who were clinically unstable,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vıdeo Streaming with Vırtual Realıty Glasses Durıng Arterıovenous Fıstula Needle Insertıonon on Paın and Anxıety of Indıvıduals Undergoıng Haemodıalysıs Treatment
This study was conducted to examine the effect of a video played with VRG during arteriovenous fistula needle insertionon pain and anxiety of patients undergoing haemodialysis treatment. The sample of the study consisted of a total of 80 patients including 40 in the interventiongroup and 40 in control group who were treated in the haemodialysis ward. The data were collected using aPersonal Information Form prepared by the researcher upon review of the relevant literature to identify the patient's descriptive and medical characteristics, the Visual Analogue Scale (VAS) to assess the severity of pain, and the State-Trait Anxiety Inventory to determine the level of anxiety and VRH.
Read the detailed description
The data were collected using a Patient Information Form prepared by the researcher upon review of the relevant literature to identify the patient's descriptive and medical characteristics, the Visual Analogue Scale (VAS) to assess the severity of pain, and the State-Trait Anxiety Inventory to determine the level of anxiety and VRH. Additionally, the "Informed Voluntary Consent Form" was used to inform the participants about the study and obtain their consent Individuals who met the inclusion criteria and signed the informed consent form were assigned to the study groups based on a list which was numbered and generated in the computer environment before the AVF procedure. According to the results given by the computer programme, the individuals were assigned to the control group and the VRGgroup.While the control group included patients who
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 underwent AVF procedure with the standard method, the virtual reality glasses group included patients who underwent AVF procedure during the VRGapplication. Nurses working in the haemodialysisunit at the time of the study performed AVF procedures in accordance with the haemodialysis procedure protocol. The researcher filled in the descriptive data of the individuals using patient and file records.The individuals were informed about the VAS and the State-Trait Anxiety Inventory.
- Being tested
- VIRTUAL REALITY GLASSES (VRG)
- Keywords
- Anxiety, Hemodialysis, Virtual reality glasses, Pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRTUAL REALITY GLASSES (VRG)Device
Individuals who met the inclusion criteria and signed the informed consent form were assigned to the study groups based on a list which was numbered and generated in the computer environment before the arteriovenous fistula (AVF) procedure. According to the results given by the computer programme, the individuals were assigned to the control group and the virtual realitiy group (VRG)group. While the control group included patients who underwent AVF procedure with the standard method, the virtual reality headset group included patients who underwent AVF procedure during the VRG application.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | The AVF catheter was inserted into the patients in the virtual reality group just before the clinic's standard haemodialysis procedure (5 minutes earlier), and the video continued to be played until the end of ten minutes after they were connected to the haemodialysis machine. Five minutes after the individual began watching the video, a routine AVF procedure was performed while the individual was still watching the video. During the haemodialysis, the patients in the VRGgroup were allowed to watch videos that they wanted to watch, such as walking in parks, nature and seaside hikes, underwater, museum tours, and feature films with VRGfor 10 minutes. After the time was up, the virtual reality application was terminated, and the VAS and the State-Trait Anxiety Inventory were filled out. Receives: Device: VIRTUAL REALITY GLASSES (VRG) |
| control | No intervention | The control group was subjected to AVF catheter insertion for the standard haemodialysis procedure of the clinic. According to this standard practice, the patients were not subjected to any procedure before AVF access. After they were connected to the haemodialysis machine, the VAS and the StateTrait Anxiety Inventory were completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) is a tool used to assess the severity of pain. The visual analog scale is a pain rating scale first used by Hayes and Patterson in 1921. It is used to quantify pain that cannot be measured numerically. Two extreme definitions of the pain parameter are written on the two ends of a 100-mm strip, and the patient is asked to indicate where his or her condition fits on this strip by drawing a line, dotting, or marking. It was also found that this scale was easy to understand and applicable for patients over five years of age and was a successful method for assessing the effectiveness of the pain relief method applied. It is a 100-mm (10-cm) ruler that can be used either horizontally or vertically, with no pain at one end and the worst pain at the other end."0 mm" indicates no pain, and "100 mm" indicates the worst pain. The individual indicates the severity of pain felt on this ruler. Based on these data, the horizontally prepared VAS was used to identify th
Measured: one week
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory was developed by Spielberger et al., to assess state and trait anxiety levels and adapted into Turkish by Öner and Lecompte.The scale is based on the two-factor anxiety concept. The Kuder-Richardson reliability of the inventory was found to range from 83 to 87 for the trait anxiety subscale and 94 to 96 for the state anxiety subscale.
The test-retest reliability rates of the inventory ranged from 71 to 86 for the trait anxiety subscale and from 26 to 68 for the State Anxiety subscale and were considered adequate.In this study, Cronbach's alpha reliability coefficient of the State-Trait Anxiety Inventory was found to be 0.73 for the State Anxiety Inventory and 0.75 for the Trait Anxiety Inventory. The State-Trait Anxiety Inventory consists of a total of 40 items. The first 20 items assess the state-related anxiety level, while the items from 21 to 40 assess the trait anxiety level of the individual.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Mar 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
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 AnxietyStudies 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
- Model description
- This study was designed as a randomized, controlled experimental clinical trial to determine the effectiveness of a video played with virtual reality glasseson pain at the vascular access site and anxiety during an AVF catheter procedure in individuals who were undergoing haemodialysis treatment.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk Ozturk
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Sponsor-investigator, Selcuk Ozturk, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776497
- Sponsor's protocol ID
- ERU-SBF-SS-38
- Acronym
- Pain
- Status last verified
- Mar 2024
- First submitted
- 10 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: there is no plan
Publications
Guler S, Ozturk S, Sahan S, Topaloglu US. The Effect of Video Streaming With Virtual Reality Glasses During Arteriovenous Fistula Needle Insertion on Pain and Anxiety of Individuals Undergoing Hemodialysis Treatment. Hemodial Int. 2026 Jan;30(1):37-45. doi: 10.1111/hdi.70010. Epub 2025 Jul 24.
PubMed 40702947
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vıdeo Streaming with Vırtual Realıty Glasses Durıng Arterıovenous Fıstula Needle Insertıonon on Paın and Anxıety of Indıvıduals Undergoıng Haemodıalysıs Treatment
- ClinicalTrials.gov ID
- NCT06776497
- Acronym / sponsor ID
- Pain / ERU-SBF-SS-38
- Keywords
- Anxiety, Hemodialysis, Virtual reality glasses, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Selcuk OzturkUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 15 Jan 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 was conducted to examine the effect of a video played with VRG during arteriovenous fistula needle insertionon pain and anxiety of patients undergoing haemodialysis treatment. The sample of the study consisted of a total of 80 patients including 40 in the interventiongroup and 40 in control group who were treated in the haemodialysis ward. The data were collected using aPersonal Information Form prepared by the researcher upon review of the relevant literature to identify the patient's descriptive and medical characteristics, the Visual Analogue Scale (VAS) to assess the severity of pain, and the State-Trait Anxiety Inventory to determine the level of anxiety and VRH.
Detailed description
The data were collected using a Patient Information Form prepared by the researcher upon review of the relevant literature to identify the patient's descriptive and medical characteristics, the Visual Analogue Scale (VAS) to assess the severity of pain, and the State-Trait Anxiety Inventory to determine the level of anxiety and VRH. Additionally, the "Informed Voluntary Consent Form" was used to inform the participants about the study and obtain their consent Individuals who met the inclusion criteria and signed the informed consent form were assigned to the study groups based on a list which was numbered and generated in the computer environment before the AVF procedure. According to the results given by the computer programme, the individuals were assigned to the control group and the VRGgroup.While the control group included patients who
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 underwent AVF procedure with the standard method, the virtual reality glasses group included patients who underwent AVF procedure during the VRGapplication. Nurses working in the haemodialysisunit at the time of the study performed AVF procedures in accordance with the haemodialysis procedure protocol. The researcher filled in the descriptive data of the individuals using patient and file records.The individuals were informed about the VAS and the State-Trait Anxiety Inventory.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a randomized, controlled experimental clinical trial to determine the effectiveness of a video played with virtual reality glasseson pain at the vascular access site and anxiety during an AVF catheter procedure in individuals who were undergoing haemodialysis treatment.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: VIRTUAL REALITY GLASSES (VRG)The AVF catheter was inserted into the patients in the virtual reality group just before the clinic's standard haemodialysis procedure (5 minutes earlier), and the video continued to be played until the end of ten minutes after they were connected to the haemodialysis machine. Five minutes after the individual began watching the video, a routine AVF procedure was performed while the individual was still watching the video. During the haemodialysis, the patients in the VRGgroup were allowed to watch videos that they wanted to watch, such as walking in parks, nature and seaside hikes, underwater, museum tours, and feature films with VRGfor 10 minutes. After the time was up, the virtual reality application was terminated, and the VAS and the State-Trait Anxiety Inventory were filled out. |
| control | No intervention | –The control group was subjected to AVF catheter insertion for the standard haemodialysis procedure of the clinic. According to this standard practice, the patients were not subjected to any procedure before AVF access. After they were connected to the haemodialysis machine, the VAS and the StateTrait Anxiety Inventory were completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Those aged 18 years and older,
- Those who were not pregnant and had no plans to become pregnant,
- Those who had been undergoing HD treatment in HD wards for at least three months and three sessions per week,
- Those who continued dialysis treatment at the same institution,
- Those for whom there were no changes in the treatment programme during the research period,
Key exclusion criteria (5 listed)
- Those who declined to participate in the study,
- Those with a diagnosed neurological disease such as epilepsy, Alzheimer's disease, Parkinson's disease,and Multiple Sclerosis.
- Those with visual and hearing impairments,
- Those who took anxiolytic and/or sedative medications,
- Those who were clinically unstable,
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 REALITY GLASSES (VRG)Individuals who met the inclusion criteria and signed the informed consent form were assigned to the study groups based on a list which was numbered and generated in the computer environment before the arteriovenous fistula (AVF) procedure. According to the results given by the computer programme, the individuals were assigned to the control group and the virtual realitiy group (VRG)group. While the control group included patients who underwent AVF procedure with the standard method, the virtual reality headset group included patients who underwent AVF procedure during the VRG application. | Device | intervention |
Primary outcome
The Visual Analogue Scale (VAS)
Time frame: one week
The Visual Analogue Scale (VAS) is a tool used to assess the severity of pain. The visual analog scale is a pain rating scale first used by Hayes and Patterson in 1921. It is used to quantify pain that cannot be measured numerically. Two extreme definitions of the pain parameter are written on the two ends of a 100-mm strip, and the patient is asked to indicate where his or her condition fits on this strip by drawing a line, dotting, or marking. It was also found that this scale was easy to understand and applicable for patients over five years of age and was a successful method for assessing the effectiveness of the pain relief method applied. It is a 100-mm (10-cm) ruler that can be used either horizontally or vertically, with no pain at one end and the worst pain at the other end."0 mm" indicates no pain, and "100 mm" indicates the worst pain. The individual indicates the severity of pain felt on this ruler. Based on these data, the horizontally prepared VAS was used to identify th
State-Trait Anxiety Inventory
Time frame: one week
State-Trait Anxiety Inventory was developed by Spielberger et al., to assess state and trait anxiety levels and adapted into Turkish by Öner and Lecompte.The scale is based on the two-factor anxiety concept. The Kuder-Richardson reliability of the inventory was found to range from 83 to 87 for the trait anxiety subscale and 94 to 96 for the state anxiety subscale. The test-retest reliability rates of the inventory ranged from 71 to 86 for the trait anxiety subscale and from 26 to 68 for the State Anxiety subscale and were considered adequate.In this study, Cronbach's alpha reliability coefficient of the State-Trait Anxiety Inventory was found to be 0.73 for the State Anxiety Inventory and 0.75 for the Trait Anxiety Inventory. The State-Trait Anxiety Inventory consists of a total of 40 items. The first 20 items assess the state-related anxiety level, while the items from 21 to 40 assess the trait anxiety level of the individual.
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 Jan 2025.
- Derived from this study: PubMed 40702947Guler S, Ozturk S, Sahan S, Topaloglu US. The Effect of Video Streaming With Virtual Reality Glasses During Arteriovenous Fistula Needle Insertion on Pain and Anxiety of Individuals Undergoing Hemodialysis Treatment. Hemodial Int. 2026 Jan;30(1):37-45. doi: 10.1111/hdi.70010. Epub 2025 Jul 24.
- Individual participant dataSharing planned: No. there is no plan
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIRTUAL REALITY GLASSES (VRG) in people with Anxiety and Pain, run by Selcuk Ozturk 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 9 inclusion and 5 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 Jan 2025. 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?
The Visual Analogue Scale (VAS) (time frame: one week). The study lists 2 primary outcomes in all. 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 NCT06776497, 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 Jan 2025.