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

NCT ID: NCT05538039

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2024-03-28

Brief Summary

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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

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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.

Conditions

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Preoperative Care Child Parent Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single (Participant)

Study Groups

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Distract with play dough

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.

Group Type EXPERIMENTAL

Distract with play dough

Intervention Type OTHER

Distract with play dough

Distract with play kaleidoscope

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.

Group Type EXPERIMENTAL

Distract with play kaleidoscope

Intervention Type OTHER

Distract with play kaleidoscope

Control Group

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

Group Type OTHER

Control group

Intervention Type OTHER

Routine nursing care

Interventions

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Distract with play dough

Distract with play dough

Intervention Type OTHER

Distract with play kaleidoscope

Distract with play kaleidoscope

Intervention Type OTHER

Control group

Routine nursing care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role collaborator

Isparta University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fahriye RN PAZARCIKCI, PhD

Role: STUDY_DIRECTOR

Isparta University of Applied Sciences

Fatma RN TIRAŞ

Role: STUDY_CHAIR

Akdeniz University

Şevkiye RN DİKMEN

Role: STUDY_CHAIR

Akdeniz University

Emine RN EFE, Professor

Role: STUDY_CHAIR

Akdeniz University

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26847781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32703758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31576651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30413359 (View on PubMed)

Other Identifiers

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IspartaUAS

Identifier Type: -

Identifier Source: org_study_id

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