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

Anxiety Clinical Trial

Official title:

The Effect of Video-Assisted Operating Room Introduce Program (VIASP-OR) Developed for Parents on Parental and Child Anxiety: Randomized Controlled Study Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05186766
• Other study ID #: KAEK-741
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: January 2022
• Source: Akdeniz University
• Contact: Cafer Özdemir
• Phone: 05069665581
• Email: cozdemir[@]akdeniz.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 (…………).

Description:

It is a fact that an advanced care process that can provide the necessary support to the parents is needed to reduce the anxiety levels before the surgery. Preparation for surgery for the child and family should focus on their unique needs and include a holistic approach to the child's physical and psychological preparation. For this reason, there is a need for studies that include a holistic approach to managing child and parent anxiety together in line with the family-centered care philosophy. There are different interventions applied to reduce child and parent anxiety in the preoperative process. Examples of these interventions are simply explaining complex information to parents by visualizing data via a tablet computer, clown intervention, distraction through music, humor, therapeutic play, and audio-visual methods. Introducing the real operating room environment, which is full of unknowns and other than traditional education methods, with video can have a positive effect on reducing the anxiety of parents and children. For this reason, we think that such a study will make a positive contribution to the literature.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Parents of children aged 7-12
• Parents whose child will undergo surgery for the first time
• Parents of children who will undergo elective surgery
• Parents who can speak Turkish, understand what they read and listen to, and can apply what is said will be included.

Exclusion Criteria:

• Parents with previous surgical experience
• Parents who used psychiatric drugs
• Parents with a child receiving sedative premedication

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Parent-Child Relations

Intervention

Device:
• Video-Assisted Operating Room Introduce Program
Video demonstration about operation room

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Anxiety-	The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.	First day before operation
Primary	Parent Anxiety	The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.	First day after operation
Primary	Parent Anxiety	The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.	Second day after operation
Secondary	Child anxiety	Facial Affective Scale (FAS) The FAS used for children consists of 5 facial expressions. In expressions ranging from 1 to 5, the first facial expression indicates no anxiety, and the fifth facial expression indicates a very high level of anxiety.	First day before operation
Secondary	Child anxiety	Facial Affective Scale (FAS) The FAS used for children consists of 5 facial expressions. In expressions ranging from 1 to 5, the first facial expression indicates no anxiety, and the fifth facial expression indicates a very high level of anxiety.	First day after operation
Secondary	Child anxiety	Facial Affective Scale (FAS) The FAS used for children consists of 5 facial expressions. In expressions ranging from 1 to 5, the first facial expression indicates no anxiety, and the fifth facial expression indicates a very high level of anxiety.	Second day after operation