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

NCT05186766 | Unknown

• 1 other identifier: KAEK-741
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 (…………).

Conditions

Anxiety; Parent-Child Relations

Keywords

Children; Parents; Anxiety; Technology; Video; Surgery

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Child anxiety

  First day before operation

• Child anxiety

  First day after operation

• Child anxiety

  Second day after operation

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: Video-Assisted Operating Room Introduce Program

Control Group

NO INTERVENTION

Standart Nursing Care

Interventions

Video-Assisted Operating Room Introduce Program DEVICE

Video demonstration about operation room

Also known as: VIASP-OR

Intervention Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35995689 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ebru KARAZEYBEK

  Akdeniz University Faculty of Nursing

  STUDY DIRECTOR

• Aysegul ISLER DALGIC

  Akdeniz University Faculty of Nursing

  STUDY DIRECTOR

Central Study Contacts

Cafer Özdemir

CONTACT

05069665581; cozdemir@akdeniz.edu.tr

Mustafa Volkan DUZGUN

CONTACT

+905079967991; mvduzgun@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Researcher

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 11, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)