NCT06629571

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable surgery

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

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

September 20, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

SurgeryAnxiety

Outcome Measures

Primary Outcomes (1)

  • STAI Form TX I,STAI Form TX II

    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

Study Arms (2)

Experimental

EXPERIMENTAL

Patient education

Other: Education

Control

NO INTERVENTION

No patient education

Interventions

Training for the patient before surgery

Also known as: Surgery Education
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MarmaraU

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

October 8, 2024

Study Start

January 1, 2024

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations