PainVRNCT06675877
Impact of Virtual Reality on Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.
A study testing virtual reality camera in people with Pain and Anxiety, run by Tanta University at 1 site in Egypt.
Trial summary
This case control study will be conducted to study the effectiveness of Virtual Reality technique on pain during arteriovenous cannulation and on reduction of anxiety and depression in Pediatric Patients with ESRD undergoing regular hemodialysis through arteriovenous fistula. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- What is being tested?
- virtual reality camera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with end stage renal disease aged from 8 to 18 years on regular hemodialysis through functioning arteriovenous fistula and are fully oriented with time, persons and place at time of data collection. All participants either cases or controls suffer from anxiety, depression or both.
Who cannot join
- Children with temporary or permanent catheter for dialysis.
- Children with mental illness, visual and auditory defects.
- Children took any pharmacological pain reliever or antipsychotic drugs.
- Non anxious or depressed Children.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, 31527
sara mabrouk lecturer of pediatrics, MD, 01099204120 ext. 20, sara.mabrouk@med.tanta.edu.eg
About this study
Official title: Impact of Virtual Reality on Pain, Anxiety and Depression in Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.
This case control study will be conducted to study the effectiveness of Virtual Reality technique on pain during arteriovenous cannulation and on reduction of anxiety and depression in Pediatric Patients with ESRD undergoing regular hemodialysis through arteriovenous fistula.
Read the detailed description
This case control study will be conducted at nephrology and dialysis Unit Pediatric Department Tanta University Hospital (TUH) for a period of 6 months starting from April 2024.This study will be conducted on convenient sample of 60 participants. they will be classified as follow group A (cases) Group B (controls)each group will contain 30 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly at our nephrology Unit at TUH during the period of the study
- Being tested
- virtual reality camera
- Keywords
- VR, pediatric
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality cameraOther
The virtual reality eyeglasses were placed on the child's head, the child watched 3 D VR kids' cartoons or videos to distract his/her attention during needle insertion. The video was displayed through a smart phone inserted inside the virtual reality headset.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Group A Cases only will receive in each dialysis session standard care together with VR camera. Receives: Other: virtual reality camera |
| group B | No intervention | Group B control group undergo three to four dialysis sessions weekly; they will receive the standard care only in their dialysis sessions without VR camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCARED for anxiety Screen for Child Anxiety Disoders {SCARED} Child, parent version: It is a self-report screening questionnaire for anxiety disorders during hemodialysis
The SCARED is useful for generalized anxiety disorder, social anxiety disorder, phobic disorders, and potentially school anxiety problems. Cases and controls will be asked to complete the questionnaire before entering the study (examination No. I) and after its completion after 3 months (examination No. II).
Measured: 6 months
Secondary outcomes (1)
The Children's Depression Inventory scale for depression during hemodialysis
Cases and controls will be asked to complete the questionnaire of The Children's Depression Inventory scale before entering the study (examination No. I) and after its completion after 3 months (examination No. II).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Apr 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Model description
- the child lay on the bed and wore virtual reality eyeglasses, the eyeglasses were placed on the child's head, the child watched 3 D VR kids' cartoons or videos to distract his/her attention during needle insertion. The video was displayed through a smart phone inserted inside the virtual reality headset.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mabrouk Elghoul, Tanta University
- Investigators
- sara Ma ElGhoul, MD, Principal investigator, Tanta university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675877
- Sponsor's protocol ID
- VR on HD children
- Acronym
- VR
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for confidence
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality on Pain, Anxiety and Depression in Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.
- ClinicalTrials.gov ID
- NCT06675877
- Acronym / sponsor ID
- VR / VR on HD children
- Keywords
- VR, pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 5 Nov 2024 (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 case control study will be conducted to study the effectiveness of Virtual Reality technique on pain during arteriovenous cannulation and on reduction of anxiety and depression in Pediatric Patients with ESRD undergoing regular hemodialysis through arteriovenous fistula.
Detailed description
This case control study will be conducted at nephrology and dialysis Unit Pediatric Department Tanta University Hospital (TUH) for a period of 6 months starting from April 2024.This study will be conducted on convenient sample of 60 participants. they will be classified as follow group A (cases) Group B (controls)each group will contain 30 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly at our nephrology Unit at TUH during the period of the study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- the child lay on the bed and wore virtual reality eyeglasses, the eyeglasses were placed on the child's head, the child watched 3 D VR kids' cartoons or videos to distract his/her attention during needle insertion. The video was displayed through a smart phone inserted inside the virtual reality headset.
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Other: virtual reality cameraGroup A Cases only will receive in each dialysis session standard care together with VR camera. |
| group B | No intervention | –Group B control group undergo three to four dialysis sessions weekly; they will receive the standard care only in their dialysis sessions without VR camera |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients with end stage renal disease aged from 8 to 18 years on regular hemodialysis through functioning arteriovenous fistula and are fully oriented with time, persons and place at time of data collection. All participants either cases or controls suffer from anxiety, depression or both.
Key exclusion criteria (4 listed)
- Children with temporary or permanent catheter for dialysis.
- Children with mental illness, visual and auditory defects.
- Children took any pharmacological pain reliever or antipsychotic drugs.
- Non anxious or depressed Children.
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 cameraThe virtual reality eyeglasses were placed on the child's head, the child watched 3 D VR kids' cartoons or videos to distract his/her attention during needle insertion. The video was displayed through a smart phone inserted inside the virtual reality headset. | Other | group A |
Primary outcome
SCARED for anxiety Screen for Child Anxiety Disoders {SCARED} Child, parent version: It is a self-report screening questionnaire for anxiety disorders during hemodialysis
Time frame: 6 months
The SCARED is useful for generalized anxiety disorder, social anxiety disorder, phobic disorders, and potentially school anxiety problems. Cases and controls will be asked to complete the questionnaire before entering the study (examination No. I) and after its completion after 3 months (examination No. II).
1 secondary outcome
The Children's Depression Inventory scale for depression during hemodialysis
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No. for confidence
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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.
sara Ma ElGhoul, MD principal investigator
Tanta university 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 virtual reality camera in people with Pain and Anxiety, run by Tanta 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Ma ElGhoul, MD (01099204120 ext. 20, sara.mabrouk@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCARED for anxiety Screen for Child Anxiety Disoders {SCARED} Child, parent version: It is a self-report screening questionnaire for anxiety disorders during hemodialysis (time frame: 6 months). 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 5 Nov 2024.