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

NCT ID: NCT06675877

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-11-30

Brief 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.

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

Conditions

Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

group A

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

Group Type: ACTIVE_COMPARATOR

virtual reality camera

Intervention Type: OTHER

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mabrouk Elghoul

lecturer of pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sara Ma ElGhoul, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta university hospital

Locations

Tanta University Hospital

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sara Ma ElGhoul, MD

Role: CONTACT

sara.mabrouk@med.tanta.edu.eg

01099204120 ext. 20

Facility Contacts

sara mabrouk lecturer of pediatrics, MD

Role: primary

sara.mabrouk@med.tanta.edu.eg

01099204120 ext. 20

Other Identifiers

VR on HD children

Identifier Type: -

Identifier Source: org_study_id