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Completed

NCT Number: NCT06036940

Perioperative Anxiety in Children

The study was conducted to evaluate the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years. The research was carried out between 1 June - 31 November 2021 at Tekirdag Namık Kemal University Health Practice and Research Center, Department of Pediatric Surgery. A total of 66 patients, 22 patients in each group, who met the inclusion criteria and were included in the stratified randomization method, were included in the planned quasi-experimental study. Research data were obtained by using the "Patient Diagnosis Form" and the "Anxiety Scale in Preschool Children" administered before and after the surgery.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tekirdag Namık Kemal University

Tekirdağ, Suleymanpasa, 59000, Turkey (Türkiye)

About this study

Pre-operative patient education was given to the children in the first experimental group by the service nurse. The children in the second experimental group were given pre-operative patient education by the service nurse, in addition, patient visits were provided by the operating room nurse and the operating room environment was explained through play. The children in the third experimental group were given pre-operative patient education by the service nurse, after which they listened to the mother's voice recording and loving words until they went to the operating room. It was determined that 69.7% of the mothers of the children participating in the study were 30 years and older, 81.8% were married, 37.9% were undergraduate graduates, and 51.5% were unemployed. The general anxiety disorder levels of those who had no previous surgery experience were found significantly higher than those who had previous surgery experience (p<0.05). In terms of affecting the anxiety level, there was a significant difference between the preoperative methods (p<0.05). It was determined that the education given by both the service nurse and the operating room nurse together was more effective than other methods in reducing the anxiety levels of children, and there was a statistically significant difference between them. (p<0.05)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned elective surgery related to pediatric surgery,
  • Having no problems in communicating,
  • Volunteer to participate in the research
  • Children aged 4-7 years

Exclusion criteria

  • Children scheduled for emergency surgery

Treatment and study plan

Preoperative patient education given with three different methods

Other

To determine the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years.

Primary outcomes

  1. Patient Diagnosis Form

    Time frame: 5 month

    This section consists of a total of 11 questions prepared by the researcher in the light of the literature, including the introductory characteristics of patients and mothers, their previous surgical experience and their expectations from nurses.

Secondary outcomes

  1. Anxiety Scale in Preschool Children

    Time frame: 5 month

    Anxiety Scale for Preschool Children consists of a 5-point Likert scale. It is scored from 0 (not at all true), 1 (rarely true), 2 (sometimes true), 3 (quite true), 4 (very often true), from 0 to 4, and parents are expected to evaluate their children. The original scale measures 4 factors. These factors should consist of 4 sub-dimensions, social anxiety disorder, generalized anxiety disorder, separation anxiety disorder, and specific phobia. There are 29 items that are expected to be answered in total. Cronbach's Alpha values of the sub-dimensions range from .72 to .92.

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study title

COMPARISON OF 3 DIFFERENT METHODS FOR REDUCING THE LEVEL OF PERIOPERATIVE ANXIETY IN CHILDREN AGED 4-7: A RANDOMIZED CONTROLLED STUDY

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 14, 2023
Registry last updated
Sep 14, 2023

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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