The Effect of Informing Relatives of Patients With Short Messages

August 27, 2023 updated by: Figen Dıgın, Kırklareli University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

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
      • Kırklareli, Turkey, 39100
        • Kırklareli University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 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: Sms group
Relatives of patients who were sent SMS
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.
No Intervention: Control Group
Relatives of patients who were no intervation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anxiety of relatives of patients in the field of cardiovascular surgery assessed by the State Anxiety Inventory (SAI)
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Kırklareli 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)

October 10, 2021

Primary Completion (Actual)

December 10, 2022

Study Completion (Actual)

June 10, 2023

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMarcinkowskiUMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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