The Effect of Informing Relatives of Patients With Short Messages

Sponsor
Kırklareli University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05157789
Collaborator
(none)
84
1
2
20
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SMS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Effect of Informing Relatives of Patients With Short Messages on Anxiety Level During Cardiovascular Surgery
Actual Study Start Date :
Oct 10, 2021
Anticipated Primary Completion Date :
Dec 10, 2022
Anticipated Study Completion Date :
Jun 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Anxiety of relatives of patients in the field of cardiovascular surgery assessed by the State Anxiety Inventory (SAI) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kırklareli University Kırklareli Turkey 39100

Sponsors and Collaborators

  • Kırklareli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Figen Dıgın, Assistant Professor, Kırklareli University
ClinicalTrials.gov Identifier:
NCT05157789
Other Study ID Numbers:
  • KMarcinkowskiUMS
First Posted:
Dec 15, 2021
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Figen Dıgın, Assistant Professor, Kırklareli University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022