Arteriovenous FistulaNCT05326321
Effect of Virtual Reality Glasses in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction
A study testing Study Group in people with Arteriovenous Fistula, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted as a randomized controlled experimental study aiming to determine the impact of virtual reality glasses used in the AVF process on the pain felt by patients and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Study Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2018to 9 Jan 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving HD treatment
- Open to communication
- Fully oriented
- Without vision, hearing and perception problems
- Without any psychiatric illness
- Without a history of seizures such as epilepsy
Show all 11Show fewer
- HD treatment administered via AVF
- İn the last day, no injection was made into any artery or vein from the place where the intervention will be performed
- Without any signs of infection such as redness, swelling, open wound in the area where the intervention will be performed
- Standardized Mini Mental Test value is 24 points and above
- One-time needle attempt from AV
Who cannot join
- Refusing to participate in the study
- under the age of 18
- Can't speak Turkish
- Closed to communication and not fully oriented
- Visual, hearing and perception problems
- Any psychiatric illness
Show all 14Show fewer
- Having a history of seizures such as epilepsy
- HD treatment not administered via AVF
- Injection into any artery or vein from the place where the intervention will be performed in the last day,
- Any signs of infection such as redness, swelling, open wound in the area to be operated
- Using any pain medication before the procedure on the same day
- SMMT value below 24 in patients over 65 years of age
- Cannulation procedure not performed with a 16 G AVF needle
- Patients with multiple injections from the AVF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Headset Glasses Used in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction
This research was conducted as a randomized controlled experimental study aiming to determine the impact of virtual reality glasses used in the AVF process on the pain felt by patients and patient satisfaction.
Read the detailed description
Chronic kidney disease (CKD) is a progressive, irreversible renal disease in which the ability of the body to maintain the balance of metabolism, fluid and electrolytes fails. Chronic kidney disease (CKD) is one of the major health problems with an increasing prevalence in the World. Hemodialysis as one of the most common methods of renal replacement therapy is a stressful procedure despite to maintain the survival of patients with chronic kidney disease that permanent and safe vascular access is one of the requirements of a successful hemodialysis. The pain of AVF puncture is common among the patients undergoing HD as acute and chronic pain which reported in more than 82% and 92% of them, respectively. Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients.
- Conditions
- Arteriovenous Fistula
- Being tested
- Study Group
- Keywords
- Virtual Reality Glasses, Nursing, Pain, Patient Satisfaction
- Medical subject headings
- Arteriovenous Fistula, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study GroupOther
The patients in the intervention group were shown a video with virtual reality glasses for an average of 5 minutes, 2 minutes before the start of the AVF cannulation procedure and 3 minutes throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | The patients in the intervention group were shown a video with virtual reality glasses for an average of 5 minutes, 2 minutes before the start of the AVF cannulation procedure and 3 minutes throughout the procedure. After the AVF cannulation procedure was completed and 10 minutes later, the VAS and Hemodynamic Variables Follow-up Form were reapplied, and the 2nd and 3rd measurements were obtained. Patients' satisfaction was measured with VAS 10 minutes after the procedure. During the application of virtual reality glasses, a screen was pulled between the patients in the intervention and control groups so that there would be no interaction. Receives: Other: Study Group |
| Control group | No intervention | Without any application to the patients in the control group, the AVF cannulation procedure before HD was performed with the constant site-area puncture technique used by the clinic (after the patient was placed in the fowler position, the arterial needle was 3 cm away from the anastomosis at an angle of 20°-45° towards the distal, and the venous needle was from the arterial needle. 3-5 cm more proximal, again at an angle of 20°-45°) was performed by the HD nurse. The 1st, 2nd and 3rd measurements were obtained as in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluated using the Visual Analog Scale
The patient marks a value between 1 and 10 on the Visual Analog Scale (VAS). As the value increases, the severity of pain increases.
Measured: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Secondary outcomes (4)
Blood pressure
systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
Measured: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Heart rate
beats per minute
Measured: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
respiratory rate
ekspiration and inspiration per minute
Measured: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Measured: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start13 Nov 2018
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies 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
- Prospective, parallel, two-arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Lafci, Mersin University
- Investigators
- Hatice Şen, Master, Principal investigator, Pozantı State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326321
- Sponsor's protocol ID
- Mersin Universi
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Headset Glasses Used in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT05326321
- Acronym / sponsor ID
- Mersin Universi
- Conditions
- Arteriovenous Fistula
- Keywords
- Virtual Reality Glasses, Nursing, Pain, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 13 Apr 2022 (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 research was conducted as a randomized controlled experimental study aiming to determine the impact of virtual reality glasses used in the AVF process on the pain felt by patients and patient satisfaction.
Detailed description
Chronic kidney disease (CKD) is a progressive, irreversible renal disease in which the ability of the body to maintain the balance of metabolism, fluid and electrolytes fails. Chronic kidney disease (CKD) is one of the major health problems with an increasing prevalence in the World. Hemodialysis as one of the most common methods of renal replacement therapy is a stressful procedure despite to maintain the survival of patients with chronic kidney disease that permanent and safe vascular access is one of the requirements of a successful hemodialysis. The pain of AVF puncture is common among the patients undergoing HD as acute and chronic pain which reported in more than 82% and 92% of them, respectively. Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, parallel, two-arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | Other: Study GroupThe patients in the intervention group were shown a video with virtual reality glasses for an average of 5 minutes, 2 minutes before the start of the AVF cannulation procedure and 3 minutes throughout the procedure. After the AVF cannulation procedure was completed and 10 minutes later, the VAS and Hemodynamic Variables Follow-up Form were reapplied, and the 2nd and 3rd measurements were obtained. Patients' satisfaction was measured with VAS 10 minutes after the procedure. During the application of virtual reality glasses, a screen was pulled between the patients in the intervention and control groups so that there would be no interaction. |
| Control group | No intervention | –Without any application to the patients in the control group, the AVF cannulation procedure before HD was performed with the constant site-area puncture technique used by the clinic (after the patient was placed in the fowler position, the arterial needle was 3 cm away from the anastomosis at an angle of 20°-45° towards the distal, and the venous needle was from the arterial needle. 3-5 cm more proximal, again at an angle of 20°-45°) was performed by the HD nurse. The 1st, 2nd and 3rd measurements were obtained as in the intervention group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Receiving HD treatment
- Open to communication
- Fully oriented
- Without vision, hearing and perception problems
- Without any psychiatric illness
Key exclusion criteria (14 listed)
- Refusing to participate in the study
- under the age of 18
- Can't speak Turkish
- Closed to communication and not fully oriented
- Visual, hearing and perception problems
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 |
|---|---|---|
| Study GroupThe patients in the intervention group were shown a video with virtual reality glasses for an average of 5 minutes, 2 minutes before the start of the AVF cannulation procedure and 3 minutes throughout the procedure. | Other | Virtual Reality Glasses Group |
Primary outcome
Pain evaluated using the Visual Analog Scale
Time frame: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
The patient marks a value between 1 and 10 on the Visual Analog Scale (VAS). As the value increases, the severity of pain increases.
4 secondary outcomes
Blood pressure
Time frame: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
Heart rate
Time frame: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
respiratory rate
Time frame: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
peripheral oxygen saturation
Time frame: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)
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 13 Apr 2022.
- 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.
Hatice Şen, Master principal investigator
Pozantı State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group in people with Arteriovenous Fistula, run by Mersin 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 14 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 13 Apr 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?
Pain evaluated using the Visual Analog Scale (time frame: Change from before implementation, immediately after the procedure and after 10 minutes of practice (Virtual Reality Headset Glasses)). 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 13 Apr 2022.