Perioperative Anxiety in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Nurse's Role
• Intervention / Treatment: Other: Preoperative patient education given with three different methods

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Suleymanpasa
    • Tekirdag, Suleymanpasa, Turkey, 59000
      • Tekirdag Namık Kemal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: First Control Group; The children in the first control group were given pre-operative patient education by the service nurse.
Experimental: Second Experimental Group; The children in the second experimental group were given pre-operative patient education by the service nurse, also patient visits were provided by the operating room nurse and the operating room environment was explained through play.	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.
Experimental: Third Experimental Group; The children in the third experimental group were given pre-operative patient education by the service nurse, and then the mother's voice recording was played until they went to the operating room.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Namik Kemal University
• Investigators: Principal Investigator: Tülin YILDIZ, Prof. Dr., Namik Kemal University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; surgical nursing; child sick
• Other Study ID Numbers: TYILDIZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No