Pain ManagementNCT07334522
Virtual Reality Distraction for Pain and Anxiety in Hemodialysis Patients
A study testing Virtual Reality in people with Pain Management and Anxiety, run by Karbala University at 2 sites in Iraq.
Trial summary
1. Assess pain and anxiety levels in hemodialysis patients during arteriovenous fistula needle insertion. 2. Determine the effect of the distraction technique using virtual reality on pain and anxiety levels during arteriovenous fistula needle insertion in hemodialysis patients. 3. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain Management, Anxiety, Hemodialysis
- 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
- 142 participants
- Where
- 2 sitesIraq
- Study dates
- 10 Jan 2026to 10 Mar 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with End-Stage Renal Disease (ESRD) on hemodialysis.
- Patients using a functioning arteriovenous fistula (AVF).
- Conscious, oriented, and able to communicate.
- Normal or corrected vision and hearing suitable for VR use.
- Patients capable of giving written informed consent.
Who cannot join
- History of motion sickness, seizures, or epilepsy.
- Use of Central Venous Catheter (CVC) or Arteriovenous Graft (AVG).
- Use of analgesics or sedatives within 4 hours before the procedure.
- Facial wounds or eye infections preventing VR use.
- Hemodynamic instability or cognitive impairment.
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
Imam Al-Hassan Al-Mujtaba Teaching Hospital
Karbala
Imam Al-Hussain Medical City
Karbala
About this study
Official title: Effect of Distraction Technique Using Virtual Reality on Pain and Anxiety Level During Needle Insertion in Arteriovenous Fistula Among Hemodialysis Patients: A Randomized Controlled Trial
- Assess pain and anxiety levels in hemodialysis patients during arteriovenous fistula needle insertion.
- Determine the effect of the distraction technique using virtual reality on pain and anxiety levels during arteriovenous fistula needle insertion in hemodialysis patients.
- Find out the differences in the level of pain and anxiety after using virtual reality with regard to the demographic and clinical data of the sample.
Read the detailed description
Kidney Failure Requiring Replacement Therapy (KFRT) is a growing global health challenge. In 2023, the number of global cases of KFRT reached 4.59 million, affecting approximately 5 million people worldwide. Regionally, the burden is significant, with 230,000 cases reported in North Africa and the Middle East, and specifically 8,800 cases in Iraq.
Hemodialysis remains the primary life-sustaining treatment for these patients. To perform hemodialysis efficiently, a reliable vascular access is required, with the arteriovenous fistula (AVF) being the gold standard. However, the procedure requires the insertion of large-gauge needles into the fistula repeatedly (usually three times a week), which is often associated with significant pain and distress.
Needle phobia, anticipatory anxiety, and procedure-related pain are common challenges among hemodialysis patients. Unmanaged pain and anxiety can lead to poor adherence to treatment, adverse physiological responses (such as hypertension and tachycardia), and a reduced quality of life.
Virtual Reality (VR) is an immersive technology that draws the patient's attention away from the noxious stimulus by creating a simulated environment. The study aims to evaluate the efficacy of VR as a distraction method to reduce pain and anxiety during AVF cannulation in hemodialysis patients compared to standard care.
- Conditions
- Pain Management, Anxiety, Hemodialysis, Virtual Reality, Arteriovenous Fistula, Needle Insertion and Injection Pain
- Being tested
- Virtual Reality, standard of care
- Medical subject headings
- Agnosia, Anxiety Disorders, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
The intervention involves using VR glasses to provide audiovisual distraction. Participants will watch a 360-degree underwater video with calming music. The VR session starts 2 minutes before the procedure and continues for 3 minutes during the insertion
standard of careOther
Routine nursing care for AVF insertion, including skin disinfection and needle insertion according to the hospital's standard protocols, without any additional distraction techniques.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants in this group will receive distraction therapy using Virtual Reality (VR) glasses during the AVF insertion. The VR session starts 2 minutes before the procedure and continues for 3 minutes during the insertion. Utilizing the Solomon Four-Group Design, this group is randomly subdivided into two subgroups: in Subgroup A, anxiety is assessed before the intervention, while in Subgroup B, no pre-test assessment is performed. Both subgroups undergo post-test measurement for pain and anxiety immediately after the procedure. Receives: Device: Virtual Reality |
| Control Group | Active comparator | Participants in this group will receive standard routine nursing care for AVF insertion without any additional distraction techniques. Utilizing the Solomon Four-Group Design, this group is randomly subdivided into two subgroups: in Subgroup C, anxiety is assessed before the procedure, while in Subgroup D, no pre-test assessment is performed. Both subgroups undergo post-test measurement for pain and anxiety immediately after the procedure Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS). This scale consists of a 10-cm horizontal line where 0 represents "no pain" and 10 represents "worst possible pain." Participants will mark their perceived pain level on the line immediately after the needle insertion and removal of the VR glasses.
Measured: Immediately after the needle insertion procedure
Anxiety Level
The anxiety level will be assessed using the Visual Analog Scale (VAS) for Anxiety. This scale consists of a 10-cm horizontal line, where 0 indicates "no anxiety" and 10 indicates "worst possible anxiety." Participants will be asked to place a mark on the line corresponding to their perceived anxiety level immediately after the needle insertion and removal of the VR glasses.
Measured: Immediately after the needle insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start10 Jan 2026
- Primary completion28 Feb 2026
- Study completion10 Mar 2026
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.
- 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
- The study will employ a randomized controlled trial using the Solomon four-group design. A total of 150 hemodialysis patients will be recruited and randomly allocated into four groups across two dialysis centers. The design includes two groups with pre-test and post-test measurements and two groups with post-test only, allowing control for pre-test sensitization and strengthening internal validity. The intervention protocol involves the use of virtual reality distraction as follows: * 2 minutes before needle insertion: patients wear the VR headset to establish immersion. * 3 minutes during needle insertion: VR continues throughout the cannulation procedure. * Immediately after completion of needle insertion: the VR headset is removed. Measurement Strategy * Anxiety: assessed using the Visual Analogue Scale for Anxiety (VAS-A), measured before and after the intervention (for pre-test groups). * Pain: assessed using the Visual Analogue Scale (VAS), measured only after the
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karbala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astabraq Rassoul Hussein Abass, Ministry of Health, Iraq
- Investigators
- Astabraq R Hussein, MGS, Principal investigator, kerbala heath department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334522
- Sponsor's protocol ID
- UOK.CON.25.0100
- Status last verified
- Jul 2026
- First submitted
- 1 Jan 2026
- Last updated
- 13 Jul 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Distraction Technique Using Virtual Reality on Pain and Anxiety Level During Needle Insertion in Arteriovenous Fistula Among Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07334522
- Acronym / sponsor ID
- UOK.CON.25.0100
- Conditions
- Pain Management, Anxiety, Hemodialysis, Virtual Reality, Arteriovenous Fistula, Needle Insertion and Injection Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Karbala UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 12 Jan 2026 (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.
- Assess pain and anxiety levels in hemodialysis patients during arteriovenous fistula needle insertion.
- Determine the effect of the distraction technique using virtual reality on pain and anxiety levels during arteriovenous fistula needle insertion in hemodialysis patients.
- Find out the differences in the level of pain and anxiety after using virtual reality with regard to the demographic and clinical data of the sample.
Detailed description
Kidney Failure Requiring Replacement Therapy (KFRT) is a growing global health challenge. In 2023, the number of global cases of KFRT reached 4.59 million, affecting approximately 5 million people worldwide. Regionally, the burden is significant, with 230,000 cases reported in North Africa and the Middle East, and specifically 8,800 cases in Iraq.
Hemodialysis remains the primary life-sustaining treatment for these patients. To perform hemodialysis efficiently, a reliable vascular access is required, with the arteriovenous fistula (AVF) being the gold standard. However, the procedure requires the insertion of large-gauge needles into the fistula repeatedly (usually three times a week), which is often associated with significant pain and distress.
Needle phobia, anticipatory anxiety, and procedure-related pain are common challenges among hemodialysis patients. Unmanaged pain and anxiety can lead to poor adherence to treatment, adverse physiological responses (such as hypertension and tachycardia), and a reduced quality of life.
Virtual Reality (VR) is an immersive technology that draws the patient's attention away from the noxious stimulus by creating a simulated environment. The study aims to evaluate the efficacy of VR as a distraction method to reduce pain and anxiety during AVF cannulation in hemodialysis patients compared to standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will employ a randomized controlled trial using the Solomon four-group design. A total of 150 hemodialysis patients will be recruited and randomly allocated into four groups across two dialysis centers. The design includes two groups with pre-test and post-test measurements and two groups with post-test only, allowing control for pre-test sensitization and strengthening internal validity. The intervention protocol involves the use of virtual reality distraction as follows: * 2 minutes before needle insertion: patients wear the VR headset to establish immersion. * 3 minutes during needle insertion: VR continues throughout the cannulation procedure. * Immediately after completion of needle insertion: the VR headset is removed. Measurement Strategy * Anxiety: assessed using the Visual Analogue Scale for Anxiety (VAS-A), measured before and after the intervention (for pre-test groups). * Pain: assessed using the Visual Analogue Scale (VAS), measured only after the
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual RealityParticipants in this group will receive distraction therapy using Virtual Reality (VR) glasses during the AVF insertion. The VR session starts 2 minutes before the procedure and continues for 3 minutes during the insertion. Utilizing the Solomon Four-Group Design, this group is randomly subdivided into two subgroups: in Subgroup A, anxiety is assessed before the intervention, while in Subgroup B, no pre-test assessment is performed. Both subgroups undergo post-test measurement for pain and anxiety immediately after the procedure. |
| Control Group | Active comparator | Other: standard of careParticipants in this group will receive standard routine nursing care for AVF insertion without any additional distraction techniques. Utilizing the Solomon Four-Group Design, this group is randomly subdivided into two subgroups: in Subgroup C, anxiety is assessed before the procedure, while in Subgroup D, no pre-test assessment is performed. Both subgroups undergo post-test measurement for pain and anxiety immediately after the procedure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with End-Stage Renal Disease (ESRD) on hemodialysis.
- Patients using a functioning arteriovenous fistula (AVF).
- Conscious, oriented, and able to communicate.
- Normal or corrected vision and hearing suitable for VR use.
- Patients capable of giving written informed consent.
Key exclusion criteria (5 listed)
- History of motion sickness, seizures, or epilepsy.
- Use of Central Venous Catheter (CVC) or Arteriovenous Graft (AVG).
- Use of analgesics or sedatives within 4 hours before the procedure.
- Facial wounds or eye infections preventing VR use.
- Hemodynamic instability or cognitive impairment.
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 involves using VR glasses to provide audiovisual distraction. Participants will watch a 360-degree underwater video with calming music. The VR session starts 2 minutes before the procedure and continues for 3 minutes during the insertion | Device | Virtual Reality Group |
| standard of careRoutine nursing care for AVF insertion, including skin disinfection and needle insertion according to the hospital's standard protocols, without any additional distraction techniques. | Other | Control Group |
Primary outcome
pain intensity
Time frame: Immediately after the needle insertion procedure
Pain intensity will be assessed using the Visual Analog Scale (VAS). This scale consists of a 10-cm horizontal line where 0 represents "no pain" and 10 represents "worst possible pain." Participants will mark their perceived pain level on the line immediately after the needle insertion and removal of the VR glasses.
Anxiety Level
Time frame: Immediately after the needle insertion procedure
The anxiety level will be assessed using the Visual Analog Scale (VAS) for Anxiety. This scale consists of a 10-cm horizontal line, where 0 indicates "no anxiety" and 10 indicates "worst possible anxiety." Participants will be asked to place a mark on the line corresponding to their perceived anxiety level immediately after the needle insertion and removal of the VR 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 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
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.
Astabraq R Hussein, MGS principal investigator
kerbala heath department
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 Pain Management and Anxiety, run by Karbala University at 2 sites in Iraq.
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 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 13 Jul 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 Iraq. 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 intensity (time frame: Immediately after the needle insertion procedure). 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 13 Jul 2026.