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Completed

NCT Number: NCT06361069

Reducing Anxiety in Children Undergoing Day Surgery

Aim: This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery.

Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bilecik Şeyh Edebali University

Bilecik, Turkey (Türkiye)

About this study

This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery. The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods.

The study was carried out from April 2023 to January 2024, involving children aged 6-12 years admitted to the pediatric clinic of a teaching and research hospital for day surgery (tonsillectomy, circumcisio, adenotonsillectomy etc.). Notably, the nursing care provided at the hospital does not incorporate distraction techniques aimed at alleviating anxiety in children.

Sample The sample required for the study was calculated using the G*Power (3.1.9.4) computer program. Based on the Type I error of 5%, Type II error of 99%, SD = 6.20, and Type I error of 5% in the study by Dehghan et al. (2017), the desired effect size for this study was 0.55 and the total required sample size was 64 children (approximately 21 children for each group) (Dehghan et al., 2017). A total of 85 children, comprising 20 children in the control group, 22 in the finger puppet intervention group, 21 in the distraction cards intervention group, and 22 in the kaleidoscope intervention group, was recruited from the pediatric clinic between April 2023 and January 2024, meeting the study's inclusion criteria. Notably, no randomization method was employed in the selection process.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children aged 6-12 years
  • scheduled for day surgery
  • devoid of prior surgical experiences
  • willingly consented to participation.

Exclusion criteria

  • children undergoing major surgeries (e.g., cardiac procedures)
  • emergency surgical interventions
  • individuals with mental retardation
  • as well as those with visual or auditory impairments.

Treatment and study plan

distraction cards, kaleidoscope and finger puppet

Other

A kaleidoscope, characterized by vibrant patterns visible through rotation of its cylinders, operates on the principle of light refraction, producing dynamic and ever-changing visual displays.

Distraction cards feature an array of images and shapes, each measuring approximately 5-8 cm in length. These intricate designs are discernible only upon careful examination of the cards.

Puppets, as a therapeutic intervention tool, significantly influence children's personal, social, and emotional development, facilitating their comfortable expression of emotions.

Primary outcomes

  1. Anxiety

    Time frame: up to 10 months

    This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery

Sponsors and collaborators

Lead sponsor

Bilecik Seyh Edebali Universitesi

Other

Registry information

Official study title

The Efficacy of Finger Puppets, Distraction Cards and Kaleidoscope for Reducing Anxiety in Children Undergoing Day Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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