The Effect of Informing Relatives of Patients With Short Messages
Primary Purpose
Cardiovascular Surgery, Anxiety, Short Message
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SMS
Sponsored by

About this trial
This is an interventional health services research trial for Cardiovascular Surgery focused on measuring Cardiovascular surgery, anxiety, relatives of the patient, Short message
Eligibility Criteria
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
Sites / Locations
- Kırklareli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sms group
Control Group
Arm Description
Relatives of patients who were sent SMS
Relatives of patients who were no intervation
Outcomes
Primary Outcome Measures
Anxiety of relatives of patients in the field of cardiovascular surgery assessed by the State Anxiety Inventory (SAI)
Secondary Outcome Measures
Full Information
NCT ID
NCT05157789
First Posted
October 18, 2021
Last Updated
August 27, 2023
Sponsor
Kırklareli University
1. Study Identification
Unique Protocol Identification Number
NCT05157789
Brief Title
The Effect of Informing Relatives of Patients With Short Messages
Official Title
The Effect of Informing Relatives of Patients With Short Messages on Anxiety Level During Cardiovascular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
June 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Surgery, Anxiety, Short Message
Keywords
Cardiovascular surgery, anxiety, relatives of the patient, Short message
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sms group
Arm Type
Experimental
Arm Description
Relatives of patients who were sent SMS
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Relatives of patients who were no intervation
Intervention Type
Other
Intervention Name(s)
SMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety of relatives of patients in the field of cardiovascular surgery assessed by the State Anxiety Inventory (SAI)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Kırklareli University
City
Kırklareli
ZIP/Postal Code
39100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Informing Relatives of Patients With Short Messages
We'll reach out to this number within 24 hrs