The Effect of Informing the Relatives of Patients Undergoing Open Heart Surgery

May 24, 2024 updated by: Esra Akdeniz, Trakya University

The Effect of Informatıon Provıded to the Relatıves of Patıents Undergoıng Open Heart Surgery on the Qualıty of Lıfe and Caregıver Burden.

The goal of this type of study clinical trial is to determine the effect of informing the relatives of patients undergoing open heart surgery on the patients; quality of life and caregiver burden.The main question it aims to answer are:

H1: Informing caregivers of patients undergoing open heart surgery improves the quality of life of patients.

H2: Informing caregivers of patients undergoing open heart surgery reduces caregiver burden.Relatives of patients who have undergone open heart surgery will be informed about home care before discharge. The researcher will compare the study group with the control group to see if the information given to the caregiver makes a difference on the patient's quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the study, patients were assigned to the study and control groups via the randomizer.org website.

The Caregiver Information Form was administered by the nurse researcher in a face-to-face meeting with the caregiver. The Patient Introduction Form was filled out by the researcher from the patients'; files. The Multidimensional Quality of Life Scale was administered by the researcher through a face-to-face interview with the patient. The Caregiving Burden Scale was introduced to the caregiver by the researcher and filled in by the caregiver himself. The Caregiver Tracking Form, prepared to track the patient and the caregiver, was applied to the caregiver by the researcher in order to determine the caregivers zero point. The first data collection was carried out 48 hours after the patient was admitted to the service and before information was given. Caregivers in the study group were given 45 minutes of training and a booklet in line with the training booklet prepared according to daily life activities aimed at improving the patients quality of life and reducing the caregiver's care burden. The caregivers in the study group were given the researcher's contact number and were able to reach the researcher whenever they needed.

Patients in the control group underwent standard procedure; No information, training booklet or contact number was provided. The Caregiver Information Form was administered by the researcher in a face-to-face meeting with the caregiver. The Patient Introduction Form was filled out by the researcher from the patients'; files. Multidimensional Quality of Life Scale was administered by the researcher. The Caregiving Burden Scale was introduced to the caregiver by the researcher and filled in by the caregiver himself. The Caregiver Tracking Form, prepared to track the patient and the caregiver, was applied to the caregiver by the researcher in order to determine the caregiver's zero point. Initial data were collected between 48 hours after the patient was admitted to the ward and before discharge.

Caregiving burden scale and multidimensional quality of life form were applied to both groups at the 4th week, 8th week and 12th week. Patients in the intervention group were informed again according to their needs.

Study Type

Interventional

Enrollment (Actual)

94

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
      • Edirne, Turkey, 22030
        • Trakya 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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for patients:

  • Over 65 years of age,
  • Does not have any psychological problems and can communicate in Turkish
  • Literate,
  • Having undergone open heart surgery for the first time
  • After being taken to the Cardiovascular Surgery Service, they are stable after completing the 48-hour critical period,
  • Elderly individuals who agreed to participate in the research constituted the patient sample of the study.

Inclusion Criteria for caregivers

  • The person who is primarily responsible for the patient care and will accompany the patient for 12 weeks, Caregivers,
  • Between the ages of 18-65,
  • Does not have any psychological problems and can communicate in Turkish,
  • The caregiver sample was created by caregiver individuals who agreed to participate in the research.

Exclusion Criteria for patients:

  • Those with neurological or metabolic diseases that may cause functional disability
  • Previously had open heart surgery
  • Patients with mental and cognitive dysfunction
  • Patients who did not attend at least one of the post-surgical evaluations for any reason were excluded from the sample.

Exclusion Criteria for caregivers

  • Those with neurological or metabolic diseases that may cause functional disability
  • Transferring the patient care to someone else during the 12-week working period,
  • Caregivers who did not attend at least one of the post-surgical evaluations for any reason were excluded from the sample.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Caregivers in the study group were given 45 minutes of training and a booklet in line with the training booklet prepared according to daily life activities aimed at improving the patient's quality of life and reducing the caregiver's care burden. The caregivers in the study group were given the researcher's contact number and were able to reach the researcher whenever they needed.
Other: informing patients with using a booklet
The intervention group was informed before discharge and was given an information booklet. A phone number was given so that the researcher could contact the nurse. In the 4th week, 8th week and 12th week, information was given according to the information needs of the patient and caregiver.
No Intervention: Control Group
Patients in the control group underwent standard procedure; No information, training booklet or contact number was provided. The Caregiver Information Form was administered by the researcher in a face-to-face meeting with the caregiver. The Patient Introduction Form was filled out by the researcher from the patients' files. Multidimensional Quality of Life Scale was administered by the researcher. The Caregiving Burden Scale was introduced to the caregiver by the researcher and filled in by the caregiver himself. The Caregiver Tracking Form, prepared to track the patient and the caregiver, was applied to the caregiver by the researcher in order to determine the caregiver's zero point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional quality of life scale
Time Frame: 12 weeks
The multidimensional quality of life scale, which is psychometrically strong, short, easy to apply and suitable for patients diagnosed with Cardiovascular Disease, is a tool developed by Avis et al. for the purpose of multidimensional measurement of HRQoL and whose Turkish validity and reliability was obtained by Demir. The total score of the scale varies between 35-245.
12 weeks
Caregiver burden scale
Time Frame: 12 weeks
It was developed by Zarit, Reever and Bach-Peterson in 1980 to evaluate the stress experienced by caregivers of individuals in need of care. The evaluation of the scale is made based on the total score, and a minimum of 0 and a maximum of 88 points can be obtained from the scale. . 0-20 points obtained from the scale are classified as "little/no burden", 21-40 points as "moderate burden", 41-60 points as "severe burden" and 61-88 points as "extreme burden". A high scale score indicates that the distress experienced is high.
12 weeks

Collaborators and Investigators

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

Sponsor

Trakya University

Investigators

  • Principal Investigator: Esra Akdeniz, BSN, Trakya Üniversite

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)

May 27, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOBAEK-2022/206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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