Reducing the Anxiety of Children and Their Parents in the Preoperative Process

NCT05279976 | Completed

• 1 other identifier: AkdUniversity
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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 to inform 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 evaluate the effect of visualized education and kaleidoscope distraction on children and parents' anxiety on the day of surgery in the preoperative period.

Conditions

Preoperative Care; Child; Parent; Anxiety

Keywords

Preoperative care; Child; Parents; Nursing; Randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• Children receiving education-Intervention group 1

  The decrease in anxiety level of children in this group who received visualized education is a measure of outcome. This decrease will be measured by the "Modified Yale Preoperative Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the surgical gown is put on. The scale consists of twenty-two items and five categories. Each category receives a score 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 an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the visualized education has an positive effect on preoperative anxiety. Statistical significance will be set at p \< 0.05.

  Anxiety levels of children during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.

• Children who are distracted-Intervention group 2

  The decrease in anxiety level of children in this group who are distracted by the keladoscope is a measure of outcome. This decrease will be measured by the "Modified Yale Preoperative Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the surgical gown is put on. The scale consists of twenty-two items and five categories. Each category receives a score 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 an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the distracted by the keladoscope has an positive effect on preoperative anxiety. Statistical significance will be set at p \< 0.05.

  Anxiety levels of children during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.

• Parents of children receiving education-Intervention group 1

  The decrease in anxiety level of parents in this group who parents of children receiving education is a measure of outcome. This decrease will be measured by the "Spielberger State Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the child to be operated on is wearing a surgical gown. 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 an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that the education has an positive effect on preoperative anxiety. Statistical significance will be set at p \< 0.05.

  Anxiety levels of parents during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.

• Parents of distracted children-Intervention group 2

  The decrease in anxiety level of parents in this group who parents of distracted children is a measure of outcome. This decrease will be measured by the "Spielberger State Anxiety Scale". In the intervention group, the first (pre-test) measurement will be made in the operating room waiting room, and the second (post-test) measurement will be made with the same measuring instrument right after the child to be operated on is wearing a surgical gown. 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 an decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distracted by the kaleidoscope has an positive effect on preoperative anxiety. Statistical significance will be set at p \< 0.05.

  Anxiety levels of parents during the preoperative period will be evaluated twice, in the operating room waiting room and immediately after the child wears the surgical gown. The second measure is the decrease in test scores, the outcome measure.

Study Arms (6)

Children receiving education-Intervention group 1 (35 children)

EXPERIMENTAL

Children in the intervention group 1 will be told by the researchers the operation preparation room and the pre-anesthesia process with a picture booklet. It will be ensured that the child and parent are together during the training. The booklet, which is printed separately for each child, will be given to the child and the parent after an average of 15-20 minutes of narration is completed. Simultaneous visual presentation will be made with the content of the picture booklet being explained to the child. While one of the researchers will explain the pre-operative process from the picture booklet, the other will explain the pre-operative preparation process simultaneously with the picture booklet by putting on the bonnet, mask and glove, and with the balloon inflated by the child. In this way, the pictures shown in the picture booklet will be matched with the real environment.

Other: Visualized Education

Children who are distracted-Intervention group 2 (35 children)

EXPERIMENTAL

Children included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes. After the attempt is over, the kaleidoscope will be presented to the child. Usage of Kaleidoscope: 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. Inside the kaleidoscope, there are mirrors or glasses placed with an inclination of 60 degrees. When viewed from one side of the kaleidoscope, images are often seen that are not the same.

Other: Distraction

Control group of children (35 children)

NO INTERVENTION

After obtaining informed consent from the children and parents included in the control group after randomization, the pre-test (first measurement) will be applied. The final test (Second Measurement) will be applied immediately after the child wears the surgical gown.

Parents of children receiving education-Intervention group 1 (35 parents)

EXPERIMENTAL

The parents of children included in intervention group 1 will also be in intervention group 1.It will be ensured that the child and parent are together during the training. The booklet, which is printed separately for each child, will be given to the child and the parent after an average of 15-20 minutes of narration is completed.

Other: Visualized Education

Parents of distracted children-Intervention group 2 (35 parents)

EXPERIMENTAL

The parents of children included in intervention group 2 will also be in intervention group 2. Children included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes.

Other: Distraction

Control group of parents (35 parents)

NO INTERVENTION

The parents of children included in control group will also be in control group.

Interventions

Visualized Education OTHER

The child assigned to intervention group 1 will be told the operation preparation room and the pre-anesthesia process through the picture booklet prepared immediately after the pre-test (first measurement). Children included in this group will be provided to touch the bonnet, mask, gloves and self-inflated balloon (representing the ambu device), and the questions of the child and the parent will be answered.

Children receiving education-Intervention group 1 (35 children); Parents of children receiving education-Intervention group 1 (35 parents)

Distraction OTHER

Children included in intervention group 2 will be given a kaleidoscope. Each child will be given a separate kaleidoscope. It will be ensured that the child is with the parent while the child is looking at the kaleidoscope for an average of 15-20 minutes. After the attempt is over, the kaleidoscope will be presented to the child.

Children who are distracted-Intervention group 2 (35 children); Parents of distracted children-Intervention group 2 (35 parents)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being a child between the ages of 5-12 for which a surgical operation is planned
• Being the parent of a child between the ages of 5 and 12 whose surgical operation is planned
• Not having vision, hearing or speech problems
• Not have a mental or neurological disability
• Children and parents who can speak and understand Turkish will be included in the study.

You may not qualify if:

• Change in surgical operation date
• Using another distraction technique
• Children who do not arrive on the day of surgery will not be included in the study.

Sponsors & Collaborators

• Akdeniz University: lead
• Isparta University of Applied Sciences: collaborator

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 26847781 BACKGROUND

• Baghele A, Dave N, Dias R, Shah H. Effect of preoperative education on anxiety in children undergoing day-care surgery. Indian J Anaesth. 2019 Jul;63(7):565-570. doi: 10.4103/ija.IJA_37_19.

  PMID: 31391620 BACKGROUND

• 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.

  PMID: 32703758 BACKGROUND

• 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.

  PMID: 31576651 BACKGROUND

• Pazarcikci F, Efe E. Effect of care programme based on Comfort Theory on reducing parental anxiety in the paediatric day surgery: Randomised controlled trial. J Clin Nurs. 2022 Apr;31(7-8):922-934. doi: 10.1111/jocn.15945. Epub 2021 Jul 8.

  PMID: 34240490 BACKGROUND

• 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.

  PMID: 30413359 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Ayla Kaya, RN, PhD

  Akdeniz University Faculty of Nursing

  STUDY DIRECTOR

• Fahriye Pazarcıkcı, RN, PhD

  Isparta University of Applied Sciences

  STUDY CHAIR

• Emine Efe, RN, PhD

  Akdeniz University Faculty of Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 15, 2022
• Study Start: June 6, 2023
• Primary Completion: June 6, 2023
• Study Completion: September 26, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)