The Effect of Preoperative Education on Anxiety (Anxiety)

October 3, 2024 updated by: Marmara University

The Effect of Education Given to Patients Before Abdominal Surgery on Anxiety: A Randomized Controlled Study

This randomized controlled study aimed to evaluate the effect of preoperative education on anxiety levels in patients undergoing abdominal surgery at a training hospital in Istanbul. The study population included patients admitted between January and June 2024. After power analysis, patients were divided into experimental (n=40) and control (n=41) groups. The experimental group received preoperative information, while the control group received standard care. Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI). Data were analyzed with SPSS, using tests such as the Mann-Whitney U and Wilcoxon Sign tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As a result of this study, the anxiety levels of patients who received preoperative information training in the prevention or reduction of anxiety were found to be lower than patients who received routine care. The lower score indicated that they experienced less anxiety or were able to manage their anxiety in the experimental group.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • MarmaraU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Admission to the general surgery clinic for abdominal surgery in category A-B-C
  • must be over the age of 18
  • To be literate- to be a writer
  • Being conscious
  • Who does not have a psychiatric disorder

Exclusion Criteria:

  • Exit the research during the study,
  • Group D and E abdominal surgery has been performed
  • don't be under the age of 18
  • Unconscious patient,
  • Who has a psychiatric disorder
  • Patients with communication disabilities or who cannot speak Turkish were determined as patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Patient education
Other: Education
Training for the patient before surgery
Other Names:
  • Surgery Education
No Intervention: Control
No patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STAI Form TX I,STAI Form TX II
Time Frame: 1 Day before the operation and 1 day after the operation
In the scoring of both scales, the total score of reversed statements is subtracted from the total score obtained from direct statements, and 50 points are added as a fixed value for STAI TX-I and 35 points for STAI TX-II. The score obtained as a result of this calculation is the individual's anxiety score. The scores obtained from both scales theoretically vary between 20 and 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety. The STAI TX-I threshold is 39-40 points. Mild anxiety is between 20-31 points, moderate anxiety is between 32-42 points, and anxiety is above 42-44 points. Since it shows how the person feels at that moment, regardless of the situation and conditions they are in, the threshold is accepted as 44-45 points in patients in the pre-operative period. A score between 40-59 points is considered moderate, and a score between 60-80 points is considered high.
1 Day before the operation and 1 day after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MarmaraU Banu Gümüş01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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