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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Immediately after the needle insertion procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astabraq R Hussien, MGS | Contact | +9647718107352 | astabraq.r@s.uokerbala.edu.iq | |
| Hassan A Athbi, Assoc. Prof | Contact | +9647721902514 | hasan.abdallh@uokerbala.edu.iq |
| Name | Affiliation | Role |
|---|---|---|
| Astabraq R Hussein, MGS | kerbala heath department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam Al-Hassan Al-Mujtaba Teaching Hospital | Karbala | Iraq | ||||
| Imam Al-Hussain Teaching Hospital |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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:
Measurement Strategy
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| standard of care | Other | Routine nursing care for AVF insertion, including skin disinfection and needle insertion according to the hospital's standard protocols, without any additional distraction techniques. |
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| Karbala |
| Iraq |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |