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Reducing Anxiety of Children and Their Parents in the Pre-elective Surgery Process

Primary Purpose

Preoperative Care, Child, Parent

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Distract with play dough
Distract with play kaleidoscope
Control group
Sponsored by
Isparta University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preoperative Care focused on measuring Preoperative Care, Child, Parents, Nursing care, Randomized controlled trial

Eligibility Criteria

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

Inclusion Criteria:

  • Being a child between the ages of 5 and 12 who is planned for elective surgery
  • Being the parent of a 5-12 year old child scheduled for elective surgery
  • Child and parent have no vision, hearing or speech problems
  • Child and parent do not have a mental or neurological disability
  • The child and parents do not have an anxiety disorder
  • Child and parent can speak and understand Turkish

Exclusion Criteria:

  • Change in surgical operation date
  • Using another distraction technique

Sites / Locations

  • Akdeniz UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Distract with play dough

Distract with play kaleidoscope

Control Group

Arm Description

The intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with play dough will be conducted under investigative coaching for at least 10 minutes. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each family will be given 4 boxes of play dough. After the play is played, the play dough will not be put back in the package, and the child and parents will be told that they can keep the shapes they have made if they wish. The play dough used will be provided by the researchers and will be given to the participants after the intervention.

The intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with the kaleidoscope will be conducted under investigative coaching for at least 10 minutes. It is a game tool that reproduces the outside image when viewed from inside the kaleidoscope. This image is obtained thanks to the glasses placed inside the kaleidoscope at different angles, and the images change as the kaleidoscope is rotated. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each child and parent will be given a separate kaleidoscope.

The participants in the control group will be given routine nursing care.

Outcomes

Primary Outcome Measures

Reducing children's pre-operative anxiety
The decrease in anxiety levels of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This reduction will be measured with the "Modified Yale Preoperative Anxiety Scale". Outcome criteria will be evaluated twice, approximately 30 minutes before premedication and immediately before premedication (pretest-posttest) in the Pediatric Surgery Service. The scale consists of twenty-two items and five categories. Each category gets one point out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05.
Reducing parent's pre-operative anxiety
The decrease in anxiety levels of parents of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured by the "Spielberger State Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2022
Last Updated
January 30, 2023
Sponsor
Isparta University of Applied Sciences
Collaborators
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05538039
Brief Title
Reducing Anxiety of Children and Their Parents in the Pre-elective Surgery Process
Official Title
Comparison of the Effectiveness of Two Different Distraction Interventions in Reducing Preoperative Anxiety of Children and Parents Who Are Scheduled for Elective Surgery: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isparta University of Applied Sciences
Collaborators
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
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is distraction interventions the child and family with preoperative family-centered activities. Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety. This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery
Detailed Description
Aim: This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery Method: This study was planned as a randomized controlled trial. The sample of the study will consist of 105 children aged 5-12, who will be operated on at Akdeniz University Hospital, and their parents. Randomization result; It was planned to include a total of 105 children and their parents in 3 groups: distraction with play dough group (intervention group 1)= 35, distraction with kaleidoscope group (intervention group 2)= 35 , and control group= 35 children and parents. Child and parent information form will be used to collect data, Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample, and Spielberger State Anxiety Scale will be used to collect data in parent sample. Intervention and Data Collection: Randomization will be performed after the purpose of the study is explained to the child and parent who agreed to participate in the study and after obtaining consent. Immediately after the pre-test (first measurement) is given to the children assigned to intervention group 1 and their parents, attempts to distract attention with play dough will be applied for 10 minutes. If they wish, the child and parents will be told that they can continue to play with the play dough until premedication. Children assigned to intervention group 2 and their parents will be distracted with a kaleidoscope for 10 minutes immediately after the pre-test (first measurement) is done. If they wish, the child and parents will be told that they can continue to play with the kaleidoscope until premedication. Participants randomized to the control group will be given routine standard nursing care. The second measurement will be administered 15 minutes after the interventions (before premedication=post test), and the control group 25 minutes after the first measurement (before premedication=posttest). Thus, the effectiveness of the initiatives and their comparison with each other will be evaluated. The data of the research will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The process of evaluating the data will be carried out with the support of a statistician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Care, Child, Parent, Anxiety
Keywords
Preoperative Care, Child, Parents, Nursing care, Randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distract with play dough
Arm Type
Experimental
Arm Description
The intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with play dough will be conducted under investigative coaching for at least 10 minutes. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each family will be given 4 boxes of play dough. After the play is played, the play dough will not be put back in the package, and the child and parents will be told that they can keep the shapes they have made if they wish. The play dough used will be provided by the researchers and will be given to the participants after the intervention.
Arm Title
Distract with play kaleidoscope
Arm Type
Experimental
Arm Description
The intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with the kaleidoscope will be conducted under investigative coaching for at least 10 minutes. It is a game tool that reproduces the outside image when viewed from inside the kaleidoscope. This image is obtained thanks to the glasses placed inside the kaleidoscope at different angles, and the images change as the kaleidoscope is rotated. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each child and parent will be given a separate kaleidoscope.
Arm Title
Control Group
Arm Type
Other
Arm Description
The participants in the control group will be given routine nursing care.
Intervention Type
Other
Intervention Name(s)
Distract with play dough
Intervention Description
Distract with play dough
Intervention Type
Other
Intervention Name(s)
Distract with play kaleidoscope
Intervention Description
Distract with play kaleidoscope
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Routine nursing care
Primary Outcome Measure Information:
Title
Reducing children's pre-operative anxiety
Description
The decrease in anxiety levels of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This reduction will be measured with the "Modified Yale Preoperative Anxiety Scale". Outcome criteria will be evaluated twice, approximately 30 minutes before premedication and immediately before premedication (pretest-posttest) in the Pediatric Surgery Service. The scale consists of twenty-two items and five categories. Each category gets one point out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05.
Time Frame
Anxiety levels of children will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
Title
Reducing parent's pre-operative anxiety
Description
The decrease in anxiety levels of parents of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured by the "Spielberger State Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05.
Time Frame
Anxiety levels of parents will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being a child between the ages of 5 and 12 who is planned for elective surgery Being the parent of a 5-12 year old child scheduled for elective surgery Child and parent have no vision, hearing or speech problems Child and parent do not have a mental or neurological disability The child and parents do not have an anxiety disorder Child and parent can speak and understand Turkish Exclusion Criteria: Change in surgical operation date Using another distraction technique
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahriye RN PAZARCIKCI, PhD
Phone
+902462117014
Email
fahriyepazarcikci@isparta.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Emine RN EFE, Professor
Phone
+902423106103
Email
eefe@akdeniz.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahriye RN PAZARCIKCI, PhD
Organizational Affiliation
Isparta University of Applied Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatma RN TIRAŞ
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Şevkiye RN DİKMEN
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emine RN EFE, Professor
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fahriye PAZARCIKCI, PhD
First Name & Middle Initial & Last Name & Degree
Emine EFE, Professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
26847781
Citation
Aytekin A, Doru O, Kucukoglu S. The Effects of Distraction on Preoperative Anxiety Level in Children. J Perianesth Nurs. 2016 Feb;31(1):56-62. doi: 10.1016/j.jopan.2014.11.016. Epub 2015 Nov 11.
Results Reference
background
PubMed Identifier
32703758
Citation
Bulut M, Kucuk Alemdar D, Bulut A, Salci G. The Effect of Music Therapy, Hand Massage, and Kaleidoscope Usage on Postoperative Nausea and Vomiting, Pain, Fear, and Stress in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Dec;35(6):649-657. doi: 10.1016/j.jopan.2020.03.013. Epub 2020 Jul 20.
Results Reference
background
PubMed Identifier
31576651
Citation
Dwairej DA, Obeidat HM, Aloweidi AS. Video game distraction and anesthesia mask practice reduces children's preoperative anxiety: A randomized clinical trial. J Spec Pediatr Nurs. 2020 Jan;25(1):e12272. doi: 10.1111/jspn.12272. Epub 2019 Oct 1.
Results Reference
background
PubMed Identifier
30413359
Citation
Stewart B, Cazzell MA, Pearcy T. Single-Blinded Randomized Controlled Study on Use of Interactive Distraction Versus Oral Midazolam to Reduce Pediatric Preoperative Anxiety, Emergence Delirium, and Postanesthesia Length of Stay. J Perianesth Nurs. 2019 Jun;34(3):567-575. doi: 10.1016/j.jopan.2018.08.004. Epub 2018 Nov 7.
Results Reference
background

Learn more about this trial

Reducing Anxiety of Children and Their Parents in the Pre-elective Surgery Process

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