Clinical trial NCT05538039: 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
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Care
Child
Parent
Anxiety
Keywords: Preoperative Care
Child
Parents
Nursing care
Randomized controlled trial
Lead sponsor: Isparta University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Akdeniz University
First posted: 2022-09-13
Enrollment: 210
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Reducing children's pre-operative anxiety
timeFrame: 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.
measure: Reducing parent's pre-operative anxiety
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Isparta University of Applied Sciences
name: Fahriye RN PAZARCIKCI, PhD
role: STUDY_DIRECTOR
affiliation: Akdeniz University
name: Fatma RN TIRAŞ
role: STUDY_CHAIR
affiliation: Akdeniz University
name: Şevkiye RN DİKMEN
role: STUDY_CHAIR
affiliation: Akdeniz University
name: Emine RN EFE, Professor
role: STUDY_CHAIR
References:
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.
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.
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.
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.