NCT06036940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 7, 2023

Last Update Submit

September 7, 2023

Conditions

Keywords

Anxietychild sicksurgical nursing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Anxiety Scale in Preschool Children

    5 month

Study Arms (3)

First Control Group

NO INTERVENTION

The children in the first control group were given pre-operative patient education by the service nurse.

Second Experimental Group

EXPERIMENTAL

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

Third Experimental Group

EXPERIMENTAL

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

Interventions

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.

Second Experimental GroupThird Experimental Group

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children scheduled for emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdag Namık Kemal University

Tekirdağ, Suleymanpasa, 59000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Tülin YILDIZ, Prof. Dr.

    Namik Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 14, 2023

Study Start

June 1, 2021

Primary Completion

November 30, 2021

Study Completion

February 7, 2022

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations