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
1 other identifier
interventional
66
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2022
CompletedFirst Submitted
Initial submission to the registry
September 7, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedSeptember 14, 2023
September 1, 2023
6 months
September 7, 2023
September 7, 2023
Conditions
Keywords
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 INTERVENTIONThe children in the first control group were given pre-operative patient education by the service nurse.
Second Experimental Group
EXPERIMENTALThe 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.
Third Experimental Group
EXPERIMENTALThe 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.
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.
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tülin YILDIZ, Prof. Dr.
Namik Kemal University
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