NCT05157789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

October 18, 2021

Last Update Submit

August 27, 2023

Conditions

Cardiovascular SurgeryAnxietyShort Message

Keywords

Cardiovascular surgeryanxietyrelatives of the patientShort message

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (2)

Sms group

EXPERIMENTAL

Relatives of patients who were sent SMS

Other: SMS

Control Group

NO INTERVENTION

Relatives of patients who were no intervation

Interventions

SMSOTHER

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.

Sms group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırklareli University

Kırklareli, 39100, Turkey (Türkiye)

Location

Related Publications (1)

  • Sisman C, Digin F. The Effect of Informing Patient Relatives with a Short Message on Anxiety Levels during Cardiovascular Surgery in Turkiye: A Randomized Controlled Trial. Niger J Clin Pract. 2024 Jun 1;27(6):708-715. doi: 10.4103/njcp.njcp_607_23. Epub 2024 Jun 29.

    PMID: 38943294DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 18, 2021

First Posted

December 15, 2021

Study Start

October 10, 2021

Primary Completion

December 10, 2022

Study Completion

June 10, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations

TU(1)