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NCT Number: NCT06675877

Impact of Virtual Reality on 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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospital

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

sara mabrouk lecturer of pediatrics, MD

CONTACT

[email protected]

01099204120 ext. 20

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    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).

Secondary outcomes

  1. The Children's Depression Inventory scale for depression during hemodialysis

    Time frame: 6 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Ma ElGhoul, MD

CONTACT

[email protected]

01099204120 ext. 20

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Impact of Virtual Reality on Pain, Anxiety and Depression in Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.

Acronym: VR

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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