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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety
• Intervention / Treatment: Other: virtual reality camera

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Ma ElGhoul, MD; Phone Number: 20 01099204120; Email: sara.mabrouk@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Recruiting
    • Tanta University Hospital
    • Contact: sara mabrouk lecturer of pediatrics, MD; Phone Number: 20 01099204120; Email: sara.mabrouk@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; Group A Cases only will receive in each dialysis session standard care together with VR camera.	Other: virtual 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: sara Ma ElGhoul, MD, Tanta University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; VR
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: VR on HD children

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: for confidence

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No