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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05157789
Other study ID # KMarcinkowskiUMS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2021
Est. completion date June 10, 2023

Study information

Verified date August 2023
Source Kirklareli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Surgical intervention is a planned or unplanned procedure performed to eliminate the existing or subsequent abnormal conditions in the individual's body, to reduce the effects of these conditions, or to remove the abnormal structures from the individual's body to eliminate the existing distress. While surgical interventions also cause anxiety in patients, it is known that they also cause significant anxiety in patients' relatives.This study was planned as a randomized controlled experimental study in order to examine the effect of this information on the anxiety level of the relatives of the patients by informing the relatives of the patients about the operation process with a short message during cardiovascular surgery. In data collection; Introductory information form for the patient and patient relatives, a short message follow-up form, state and trait anxiety inventory will be used during the surgical intervention. The sample of the study will be the relatives of the patients who are willing to participate in the study. Considering the change in the state anxiety scale scores between the experimental and control groups in the study of Baydemir S. (2019), it is calculated that there is a large effect size difference. Based on this finding, in order to test a large effect size (d=0.8) difference in anxiety scale scores of patient relatives between our experimental and control groups with 5% margin of error and 95% power, a total of 84 relatives of patients, 42 from each group, were included in the study. needed was calculated. H0: Informing by text message has no effect on the anxiety of patient relatives. H1: Informing by text message has an effect on the anxiety of patient relatives.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date June 10, 2023
Est. primary completion date December 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years and over, - To know Turkish, - Being literate - Having mental adequacy, - Willingness to participate in the research, - Having an active mobile line, - Ability to use a telephone - Being in the hospital before, during and after the operation Exclusion Criteria: - Be under the age of 18, - Not knowing Turkish, - Being illiterate - Lack of mental adequacy, - Lack of active mobile line, - Inability to use the phone - Absence from the hospital before, during and after the operation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SMS
In the study, text message will be sent to relatives of the patients for informing and the effect will be determine on the level of anxiety during cardiovascular surgery.

Locations

Country Name City State
Turkey Kirklareli University Kirklareli

Sponsors (1)

Lead Sponsor Collaborator
Kirklareli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety of relatives of patients in the field of cardiovascular surgery assessed by the State Anxiety Inventory (SAI) 1 year
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