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

NCT06675877 | Recruiting

• 1 other identifier: VR on HD children
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

VR; pediatric

Outcome Measures

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).

  6 months

Secondary Outcomes (1)

• The Children's Depression Inventory scale for depression during hemodialysis

  6 months

Study Arms (2)

group A

ACTIVE COMPARATOR

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

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

Interventions

virtual reality camera 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 A

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• sara Ma ElGhoul, MD

  Tanta university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Ma ElGhoul, MD

CONTACT

01099204120; sara.mabrouk@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 5, 2024
• Study Start: April 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)