Pain ManagementNCT05399199
Virtual Reality Distraction During Arteriovenous Fistula Puncture
A study testing virtual reality distraction in people with Pain Management and Hemodialysis, run by Mansoura University at 1 site in Egypt.
Trial summary
The cannulation of arteriovenous fistula is a painful procedure in hemodialysis patients. Previous studies have shown the effectiveness of virtual reality in reducing pain during needle-related procedures Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain Management, Hemodialysis, Virtual Reality
- What is being tested?
- virtual reality distraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2022to 15 Feb 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who are under- going conventional hemodialysis three times a week
- hemodialysis period of one month or more
- having a healthy AVF access with good function
- welling to participate in study
Who cannot join
- patients who have psychiatric diseases
- panic disorder, anxiety disorder
- dysfunctional fistula
- vertigo, issues with sight, hearing, or perception
- or use painkillers within three hours before hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Distraction on Pain and Anxiety During Arteriovenous Fistula Puncture Among Hemodialysis Patients: Randomized Controlled Trial
The cannulation of arteriovenous fistula is a painful procedure in hemodialysis patients. Previous studies have shown the effectiveness of virtual reality in reducing pain during needle-related procedures
Read the detailed description
Patients undergoing hemodialysis experience anxiety and pain related to the insertion of hemodialysis needles, estimated 320 times in total per year. The pain experienced is mostly caused by needle insertion into a fistula. Pain control is one of the main nursing tasks. Pain relief leads to the acceptance of the procedure and ultimately enhances the patients' quality of life. The use of virtual reality to reduce pain and anxiety during the arteriovenous fistula cannulation procedure is based on the concept that the perception of pain can be controlled because an individual is able to process only a limited amount of information at once. As such, the use of virtual reality during painful procedures may serve as a distraction.
- Conditions
- Pain Management, Hemodialysis, Virtual Reality
- Being tested
- virtual reality distraction
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality distractionProcedure or surgery
study group patients will view VR scene for 6 minutes before puncture .It involves a soothing nature experience and calming background music. Patients in intervention group will not able to see the puncture procedure due to the VR glasses.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Procedure: virtual reality distraction |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in patients pain scores
visual analogue scale which consists of a vertical line 100 mm long, one end of the line reads "No pain" and at the other is "Unbearable pain
Measured: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients anxiety scores
STAI includes two subscales with 20 items each that assess state and trait anxiety .The State Anxiety Scale requires individuals to describe their feelings at a specific moment under specific circumstances, while the Trait Anxiety Scale requires them to describe the way they feel in general.
Measured: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Secondary outcomes (6)
change in patients satisfaction score
. The patients will be asked to rate procedure satisfaction placing a mark on a 100-mm vertical visual analogue scale
Measured: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients heart rate
checklist will be used to assess heart rate after puncture
Measured: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients respiratory rate
checklist will be used to assess respiratory rate after puncture
Measured: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients systolic blood pressure
checklist will be used to assess systolic blood pressure after puncture
Measured: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients diastolic blood pressure
checklist will be used to assess diastolic blood pressure after puncture
Measured: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients Oxygen saturation (SpO2)
checklist will be used to assess Oxygen saturation after puncture
Measured: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start5 Jun 2022
- Primary completion30 Nov 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed elsayed hamed elzeky, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399199
- Sponsor's protocol ID
- mansU
- Status last verified
- Oct 2022
- First submitted
- 22 May 2022
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Distraction on Pain and Anxiety During Arteriovenous Fistula Puncture Among Hemodialysis Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05399199
- Acronym / sponsor ID
- mansU
- Conditions
- Pain Management, Hemodialysis, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 1 Jun 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.
The cannulation of arteriovenous fistula is a painful procedure in hemodialysis patients. Previous studies have shown the effectiveness of virtual reality in reducing pain during needle-related procedures
Detailed description
Patients undergoing hemodialysis experience anxiety and pain related to the insertion of hemodialysis needles, estimated 320 times in total per year. The pain experienced is mostly caused by needle insertion into a fistula. Pain control is one of the main nursing tasks. Pain relief leads to the acceptance of the procedure and ultimately enhances the patients' quality of life. The use of virtual reality to reduce pain and anxiety during the arteriovenous fistula cannulation procedure is based on the concept that the perception of pain can be controlled because an individual is able to process only a limited amount of information at once. As such, the use of virtual reality during painful procedures may serve as a distraction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: virtual reality distraction |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients who are under- going conventional hemodialysis three times a week
- hemodialysis period of one month or more
- having a healthy AVF access with good function
- welling to participate in study
Key exclusion criteria (5 listed)
- patients who have psychiatric diseases
- panic disorder, anxiety disorder
- dysfunctional fistula
- vertigo, issues with sight, hearing, or perception
- or use painkillers within three hours before hemodialysis
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 distractionstudy group patients will view VR scene for 6 minutes before puncture .It involves a soothing nature experience and calming background music. Patients in intervention group will not able to see the puncture procedure due to the VR glasses. | Procedure or surgery | study group |
Primary outcome
change in patients pain scores
Time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
visual analogue scale which consists of a vertical line 100 mm long, one end of the line reads "No pain" and at the other is "Unbearable pain
change in patients anxiety scores
Time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
STAI includes two subscales with 20 items each that assess state and trait anxiety .The State Anxiety Scale requires individuals to describe their feelings at a specific moment under specific circumstances, while the Trait Anxiety Scale requires them to describe the way they feel in general.
6 secondary outcomes
change in patients satisfaction score
Time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients heart rate
Time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients respiratory rate
Time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients systolic blood pressure
Time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients diastolic blood pressure
Time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients Oxygen saturation (SpO2)
Time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
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 21 Feb 2023.
- 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.
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 distraction in people with Pain Management and Hemodialysis, run by Mansoura University at 1 site in Egypt.
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 4 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 21 Feb 2023. 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 Egypt. 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?
change in patients pain scores (time frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)). 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?
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 21 Feb 2023.