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

NCT ID: NCT05186766

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-08-01

Brief 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 (…………).

Detailed 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.

Conditions

Anxiety; Parent-Child Relations

Study Design

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

Study Groups

Intervention Group

Video-Assisted Operating Room Introduce Program (VIASP-OR)

Group Type: EXPERIMENTAL

Video-Assisted Operating Room Introduce Program

Intervention Type: DEVICE

Video demonstration about operation room

Control Group

Standart Nursing Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Video-Assisted Operating Room Introduce Program

Video demonstration about operation room

Intervention Type: DEVICE

Other Intervention Names

VIASP-OR

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Cafer Özdemir

Head Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru KARAZEYBEK

Role: STUDY_DIRECTOR

Akdeniz University Faculty of Nursing

Aysegul ISLER DALGIC

Role: STUDY_DIRECTOR

Akdeniz University Faculty of Nursing

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Cafer Özdemir

Role: CONTACT

cozdemir@akdeniz.edu.tr

05069665581

Mustafa Volkan DUZGUN

Role: CONTACT

mvduzgun@akdeniz.edu.tr

+905079967991

Facility Contacts

Cafer Özdemir

Role: primary

cozdemir@akdeniz.edu.tr

+905069665581

References

Ozdemir C, Duzgun MV, Karazeybek E, Isler Dalgic A. The effect of a video-assisted operating room promotion program on the anxiety levels of parents and their children: A randomized controlled trial protocol. J Pediatr Nurs. 2022 Nov-Dec;67:e150-e155. doi: 10.1016/j.pedn.2022.08.006. Epub 2022 Aug 19.

Reference Type: DERIVED

PMID: 35995689 (View on PubMed)

Other Identifiers

KAEK-741

Identifier Type: -

Identifier Source: org_study_id