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RecruitingNCT06675877VRUpdated Nov 5, 2024

Impact of Virtual Reality on Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.

An interventional study of virtual reality camera in Pain and Anxiety, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Tanta University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Apr 2024, registered Oct 2024).
  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Pain
  • Anxiety

Keywords

  • VR
  • pediatric
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Tanta University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    group A

    Group A Cases only will receive in each dialysis session standard care together with VR camera.

    Other: virtual reality camera

  • No intervention
    group B

    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

Interventions

  • Othervirtual reality camera

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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).

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Tanta University Hospital
    Tanta, 31527, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — for confidence

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Nov 2024, 7 months after the start.

Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's planned 7 months is below that.

Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2024
First posted
Nov 5, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Nov 1, 2024
CompletionEst.
Nov 30, 2024
Last update
Nov 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06675877
Lead sponsor
Tanta University
Responsible party
Sara Mabrouk Elghoul (lecturer of pediatrics, Tanta University) — Principal investigator
First posted
Nov 5, 2024
Start date
Apr 1, 2024
Primary completion
Nov 1, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Nov 5, 2024

Study contacts

Sara Ma ElGhoul, MD
Contact
sara.mabrouk@med.tanta.edu.eg
01099204120 ext. 20
sara Ma ElGhoul, MD
principal investigator · Tanta university hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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