The Effect of Informing Relatives of Patients With Short Messages

Anxiety Clinical Trial

Official title:

The Effect of Informing Relatives of Patients With Short Messages on Anxiety Level During Cardiovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05157789
• Other study ID #: KMarcinkowskiUMS
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cardiovascular Surgery

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