- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04385628
Breaking the Bad News to the Bereaved Family and Their Reactions
The Factors Affecting the Emotional Reactions of Relatives of Intensive Care Patients to the News of Death.
Study Overview
Status
Intervention / Treatment
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)
- Regular response; In this case, the relatives of the patients often describe the event as expected or my patient is now free from suffering.
- Initial shock reaction; It may be complete desperation and a state of closure,
- 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
- 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
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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İstanbul, Turkey, 34668
- Recruiting
- Sultan 2.Abdulhamidhan training hospital
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Contact:
- Bülent B güven
- Phone Number: 05336383445
- Email: barguv@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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
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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.
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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
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These three main data (Demographic data of the patient relatives, the most recent
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From admission to discharge, up to 3 month
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Denial to the bad news
Time Frame: From admission to discharge, up to 3 month
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These three main data (Demographic data of the patient relatives, the most recent
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From admission to discharge, up to 3 month
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Anger to the bad news
Time Frame: From admission to discharge, up to 3 month
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These three main data (Demographic data of the patient relatives, the most recent
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From admission to discharge, up to 3 month
|
|
Guilt to the bad news
Time Frame: From admission to discharge, up to 3 month
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These three main data (Demographic data of the patient relatives, the most recent
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From admission to discharge, up to 3 month
|
Collaborators and Investigators
Investigators
- Study Chair: selçuk Taşçı, Sultan Abdulhamidhan Training Hospital
- Study Director: ayşın ersoy, Sultan Abdulhamidhan Training Hospital
Publications and helpful links
General Publications
- 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.
- 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. doi: 10.1097/00005373-200005000-00009.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
Studies a U.S. FDA-regulated device product
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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