Breaking the Bad News to the Bereaved Family and Their Reactions

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Unknown status
CT.gov ID
NCT04385628
Collaborator
(none)
100
1
19.2
5.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: the patient' relatives satisfaction questionnaire

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Family-Based
Time Perspective:
Prospective
Official Title:
The Factors Affecting the Emotional Reactions of Relatives of Intensive Care Patients to the News of Death.
Actual Study Start Date :
Apr 25, 2019
Anticipated Primary Completion Date :
Sep 29, 2020
Anticipated Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm 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.

Behavioral: the patient' relatives satisfaction questionnaire
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.

Outcome Measures

Primary Outcome Measures

  1. Regular response to the bad news [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.

  2. Initial shock reactions to the bad news [From admission to discharge, up to 3 month]

    These three main data (Demographic data of the patient relatives, the most recent

  3. Denial to the bad news [From admission to discharge, up to 3 month]

    These three main data (Demographic data of the patient relatives, the most recent

  4. Anger to the bad news [From admission to discharge, up to 3 month]

    These three main data (Demographic data of the patient relatives, the most recent

  5. Guilt to the bad news [From admission to discharge, up to 3 month]

    These three main data (Demographic data of the patient relatives, the most recent

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sultan 2.Abdulhamidhan training hospital İstanbul Turkey 34668

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bülent Barış Güven, medical doctor, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT04385628
Other Study ID Numbers:
  • 48670771-514.10
First Posted:
May 13, 2020
Last Update Posted:
May 13, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bülent Barış Güven, medical doctor, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2020