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Completed

NCT Number: NCT05157789

The Effect of Informing Relatives of Patients With Short Messages

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırklareli University

Kırklareli, 39100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMS

Other

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 outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Kırklareli University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 15, 2021
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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