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

NCT05538039 | Completed

• 1 other identifier: IspartaUAS
• 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 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

Conditions

Preoperative Care; Child; Parent; Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  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.

Study Arms (3)

Distract with play dough

EXPERIMENTAL

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.

Other: Distract with play dough

Distract with play kaleidoscope

EXPERIMENTAL

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.

Other: Distract with play kaleidoscope

Control Group

OTHER

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

Other: Control group

Interventions

Distract with play dough OTHER

Distract with play dough

Distract with play dough

Distract with play kaleidoscope OTHER

Distract with play kaleidoscope

Distract with play kaleidoscope

Control group OTHER

Routine nursing care

Control Group

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 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

You may not qualify if:

• Change in surgical operation date
• Using another distraction technique

Sponsors & Collaborators

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

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (4)

• 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

• 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

• 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

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Fahriye RN PAZARCIKCI, PhD

  Isparta University of Applied Sciences

  STUDY DIRECTOR

• Fatma RN TIRAŞ

  Akdeniz University

  STUDY CHAIR

• Şevkiye RN DİKMEN

  Akdeniz University

  STUDY CHAIR

• Emine RN EFE, Professor

  Akdeniz University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: September 16, 2022
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

TU (1)