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

Primary Purpose

Anxiety, Parent-Child Relations

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video-Assisted Operating Room Introduce Program
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Children, Parents, Anxiety, Technology, Video, Surgery

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

Standart Nursing Care

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 9, 2021
Last Updated
January 30, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05186766
Brief Title
The Effect of Video-Assisted Operating Room Introduce Program (VIASP-OR)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Parent-Child Relations
Keywords
Children, Parents, Anxiety, Technology, Video, Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Video-Assisted Operating Room Introduce Program (VIASP-OR)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standart Nursing Care
Intervention Type
Device
Intervention Name(s)
Video-Assisted Operating Room Introduce Program
Other Intervention Name(s)
VIASP-OR
Intervention Description
Video demonstration about operation room
Primary Outcome Measure Information:
Title
Parent Anxiety-
Description
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.
Time Frame
First day before operation
Title
Parent Anxiety
Description
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.
Time Frame
First day after operation
Title
Parent Anxiety
Description
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.
Time Frame
Second day after operation
Secondary Outcome Measure Information:
Title
Child anxiety
Description
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.
Time Frame
First day before operation
Title
Child anxiety
Description
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.
Time Frame
First day after operation
Title
Child anxiety
Description
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.
Time Frame
Second day after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cafer Özdemir
Phone
05069665581
Email
cozdemir@akdeniz.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Volkan DUZGUN
Phone
+905079967991
Email
mvduzgun@akdeniz.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru KARAZEYBEK
Organizational Affiliation
Akdeniz University Faculty of Nursing
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aysegul ISLER DALGIC
Organizational Affiliation
Akdeniz University Faculty of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cafer Özdemir
Phone
+905069665581
Email
cozdemir@akdeniz.edu.tr
First Name & Middle Initial & Last Name & Degree
Cafer OZDEMİR
First Name & Middle Initial & Last Name & Degree
Mustafa Volkan DUZGUN
First Name & Middle Initial & Last Name & Degree
Ebru KARAZEYBEK
First Name & Middle Initial & Last Name & Degree
Ayşegül ISLER DALGIC

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35995689
Citation
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.
Results Reference
derived

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

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