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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06036940
Other study ID # TYILDIZ
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date February 7, 2022

Study information

Verified date September 2023
Source Namik Kemal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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)


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date February 7, 2022
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 7 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Preoperative patient education given with three different methods
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.

Locations

Country Name City State
Turkey Tekirdag Namik Kemal University Tekirdag Suleymanpasa

Sponsors (1)

Lead Sponsor Collaborator
Namik Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Diagnosis Form 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. 5 month
Secondary Anxiety Scale in Preschool Children 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. 5 month
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