Perioperative Anxiety in Children

Sponsor

Namik Kemal University (Other)

Overall Status

Completed

CT.gov ID

NCT06036940

Collaborator

(none)

Enrollment

Location

Arms

8.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nurse's Role	Other: Preoperative patient education given with three different methods	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Feb 7, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient Diagnosis Form [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 Outcome Measures

Anxiety Scale in Preschool Children [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tekirdag Namık Kemal University	Tekirdag	Suleymanpasa	Turkey	59000

Sponsors and Collaborators

Namik Kemal University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tülin YILDIZ, Prof. Dr., Namik Kemal University

ClinicalTrials.gov Identifier:

NCT06036940

Other Study ID Numbers:

TYILDIZ

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tülin YILDIZ, Prof. Dr., Namik Kemal University

Anxiety

child sick

surgical nursing

Study Results

No Results Posted as of Sep 14, 2023