Breaking the Bad News to the Bereaved Family and Their Reactions

The Effective Factors on the Grief Reactions to the Death Information Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385628
• Other study ID #: 48670771-514.10
• Status: Recruiting
• Start date: April 25, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: May 2020
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: bülent baris güven
• Phone: 05336383445
• Email: barguv[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• The Effective Factors on the Grief Reactions to the Death Information

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sultan 2.Abdulhamidhan training hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Jurkovich GJ, Pierce B, Pananen L, Rivara FP. Giving bad news: the family perspective. J Trauma. 2000 May;48(5):865-70; discussion 870-3. — View Citation

Naik SB. Death in the hospital: Breaking the bad news to the bereaved family. Indian J Crit Care Med. 2013 May;17(3):178-81. doi: 10.4103/0972-5229.117067. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regular response to the bad news	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
Primary	Initial shock reactions to the bad news	These three main data (Demographic data of the patient relatives, the most recent	From admission to discharge, up to 3 month
Primary	Denial to the bad news	These three main data (Demographic data of the patient relatives, the most recent	From admission to discharge, up to 3 month
Primary	Anger to the bad news	These three main data (Demographic data of the patient relatives, the most recent	From admission to discharge, up to 3 month
Primary	Guilt to the bad news	These three main data (Demographic data of the patient relatives, the most recent	From admission to discharge, up to 3 month