Breaking the Bad News to the Bereaved Family and Their Reactions

May 9, 2020 updated by: Bülent Barış Güven, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

The Factors Affecting the Emotional Reactions of Relatives of Intensive Care Patients to the News of Death.

The demographic characteristics, satisfaction survey evaluations and emotional reactions of the relatives of the patients who are admitted to the intensive care unit and who have an expected mortality rate higher than 50% according to the Apache-2 scoring system will be investigated.

Study Overview

Detailed Description

Patients with an APACHE-2 score> 25 (Expected mortality rate> 50%) during the first 24 hours of hospitalization in the Intensive Care Unit will be included in the study. A person who comes to the most frequent visit from relatives of patients will be included in the study. Demographic data of the relative of the patient after the informed volunteer consent form has been approved (age, proximity, educational background, patient co-existence, ethnicity, marital status, number of children, history of psychological treatment and the presence of an intensive care treatment history of any family member before) will be registered. After the 3rd, 10th, and 30th days of patient admission, and once a month, the patient satisfaction survey will be filled face to face during informing the patient's relative. In this patient group with an expected mortality of> 50%, if death occurs, the information will be made to the visitor of the patient who frequently visits the patient and agrees to participate in the study. The emotional reaction of the relative of the patient participating in the study during the declaration of death will be recorded in the case report form.

Grief reaction is unique, and it will differ from one individual to another. Possible reactions of relatives of patients during the death notification (Emotional Reactions)

  1. Regular response; In this case, the relatives of the patients often describe the event as expected or my patient is now free from suffering.
  2. Initial shock reaction; It may be complete desperation and a state of closure,
  3. Denial- This is an initial defense mechanism after the unexpected, devastating news, and it should be recognized and tolerated. Acceptance may be possible by encouraging the relatives to view the body of the deceased, especially to those relatives who were not present at the time of death
  4. Anger- This is a common reaction after the sudden death of a beloved relative. The expression of this anger can vary from mild irritation to violent behavior. This can be expressed on self, hospital staff, or any other person. Anger will gradually diminish once expressed
  5. Guilt- This is nothing but the inward expression of anger and self-blame. Consoling words of the health care team will help to do away with this emotion.

Study Type

Observational

Enrollment (Anticipated)

100

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

      • İstanbul, Turkey, 34668
        • Recruiting
        • Sultan 2.Abdulhamidhan training hospital
        • Contact:

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Relatives of patients hospitalized in intensive care unit

Description

Inclusion Criteria:

  • Apache 2 score> 25 or Expected death rate> 50%,
  • Hospitalization period> 72 hours in intensive care unit -

Exclusion Criteria:

  • Apache 2 score <25 or Expected death rate <50%,
  • Those who have a stay in ICU <72 hours
  • Currently receiving psychological medication
  • Those who do not accept one of the legal heirs to participate in the study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Relatives of patients hospitalized in the intensive care unit
Demographic data of the relative of the patient (age, proximity, educational background, patient co-existence, ethnicity, marital status, number of children, history of psychological treatment and the presence of an intensive care treatment history of any family member before) will be recorded. After the 3rd, 10th, and 30th days of patient admission, and once a month, the patient satisfaction survey will be filled face to face during informing the patient's relative. These three main data (Demographic data of the patient relatives, the most recent satisfaction questionnaire and emotional reactions observed while reporting death) will be evaluated and interpreted.
The patient' relatives satisfaction questionnaire will be filled face to face during informing the patient's relatives after the 3rd, 10th, and 30th days of patient admission, and once a month. We will evaluate the most recent questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regular response to the bad news
Time Frame: From admission to discharge, up to 3 month
These three main data (Demographic data of the patient relatives, the most recent satisfaction questionnaire and emotional reactions observed while reporting death) will be evaluated and interpreted.
From admission to discharge, up to 3 month
Initial shock reactions to the bad news
Time Frame: From admission to discharge, up to 3 month
These three main data (Demographic data of the patient relatives, the most recent
From admission to discharge, up to 3 month
Denial to the bad news
Time Frame: From admission to discharge, up to 3 month
These three main data (Demographic data of the patient relatives, the most recent
From admission to discharge, up to 3 month
Anger to the bad news
Time Frame: From admission to discharge, up to 3 month
These three main data (Demographic data of the patient relatives, the most recent
From admission to discharge, up to 3 month
Guilt to the bad news
Time Frame: From admission to discharge, up to 3 month
These three main data (Demographic data of the patient relatives, the most recent
From admission to discharge, up to 3 month

Collaborators and Investigators

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

Investigators

  • Study Chair: selçuk Taşçı, Sultan Abdulhamidhan Training Hospital
  • Study Director: ayşın ersoy, Sultan Abdulhamidhan Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

April 25, 2019

Primary Completion (ANTICIPATED)

September 29, 2020

Study Completion (ANTICIPATED)

November 30, 2020

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 9, 2020

First Posted (ACTUAL)

May 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48670771-514.10

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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