NCT05186766

The Effect of Video-Assisted Operating Room Introduce Program (VIASP-OR)

Status unknown NA Last updated 1 February 2022

What this trial tests

NA trial testing Video-Assisted Operating Room Introduce Program in Anxiety in 80 participants. Status unknown.

Timeline

1 February 2022

Primary endpoint
1 February 2023

1 August 2023

Quick facts

Lead sponsor	Akdeniz University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	80
Start date	1 February 2022
Primary completion	1 February 2023
Estimated completion	1 August 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Video-Assisted Operating Room Introduce Program

Conditions studied

• Anxiety — all drugs for Anxiety →
• Parent-Child Relations — all drugs for Parent-Child Relations →

Sponsor

Akdeniz University

Who can join

Adults 7 to 12, any sex, with Anxiety or Parent-Child Relations. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aim: The aim of this study is to evaluate the effect of the video-assisted operating room promotion program developed for parents on the anxiety level of parents and children.

Design: Randomized controlled trial. Methods: The participants (N = 80) will be randomly assigned (1:1) to the intervention and control groups using block randomization. In addition to standard care, a video-assisted operating room promotion program, created by fully addressing the perioperative process, will be applied to the participants assigned to the intervention group. Participants in the control group will only receive standard care. Standard care includes verbal information about the surgical process. The sociodemographic and clinical characteristics, along with the anxiety levels of the children and their parents were measured one day before the operation, and the anxiety levels were again measured on the postoperative first and second day.

Discussion: In the literature, it is seen that pediatric surgery personnel can have a beneficial effect in reducing the anxiety of children and their parents. Among these methods, the effectiveness of distraction methods on children's anxiety has also been proven. As for parental anxiety, which can be as important as child anxiety, not enough studies have been done so far, and the existing studies have not been able to come to a decisive conclusion. If parental intervention is found to have positive effects on the child's anxiety in this study are positive, it will contribute to clinical practice and improve clinical outcomes. In this respect, it will fill this gap in the literature.

Impact: This research will add to the evidence for the effectiveness of an intervention that provides parents with visual and auditory information about the process prior to child surgery. It will benefit parents who want to support their children in managing this process. It will also support nurses working in pediatric surgery clinics.

Trial registration: It was registered at ClinicalTrials.gov in December 2021 (…………).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of a video-assisted operating room promotion program on the anxiety levels of parents and their children: A randomized controlled trial protocol.
   Özdemir C, Düzgün MV, Karazeybek E, İşler Dalgıç A. · · 2022 · cited 1× · PMID 35995689 · DOI 10.1016/j.pedn.2022.08.006