The Effective Factors on the Grief Reactions to the Death InformationNCT04385628
Breaking the Bad News to the Bereaved Family and Their Reactions
An observational study of The Effective Factors on the Grief Reactions to the Death Information, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- The Effective Factors on the Grief Reactions to the Death Information
- What is being tested?
- the patient' relatives satisfaction questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2019to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Relatives of patients hospitalized in intensive care unit
Who may be able to join
- Apache 2 score> 25 or Expected death rate> 50%,
- Hospitalization period> 72 hours in intensive care unit -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan 2.Abdulhamidhan training hospital
Istanbul, 34668
Bülent B güven, 05336383445, barguv@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- the patient' relatives satisfaction questionnaire
- Keywords
- patient death , grief reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the patient' relatives satisfaction questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: the patient' relatives satisfaction questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission to discharge, up to 3 month
Initial shock reactions to the bad news
These three main data (Demographic data of the patient relatives, the most recent
Measured: From admission to discharge, up to 3 month
Denial to the bad news
These three main data (Demographic data of the patient relatives, the most recent
Measured: From admission to discharge, up to 3 month
Anger to the bad news
These three main data (Demographic data of the patient relatives, the most recent
Measured: From admission to discharge, up to 3 month
Guilt to the bad news
These three main data (Demographic data of the patient relatives, the most recent
Measured: From admission to discharge, up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start25 Apr 2019
- Primary completion29 Sep 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for The Effective Factors on the Grief Reactions to the Death InformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bülent Barış Güven, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- selçuk Taşçı, Study chair, Sultan Abdulhamidhan Training Hospitalayşın ersoy, Study director, Sultan Abdulhamidhan Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385628
- Sponsor's protocol ID
- 48670771-514.10
- Status last verified
- May 2020
- First submitted
- 9 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 24082616Jurkovich 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.
PubMed 10823529
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Factors Affecting the Emotional Reactions of Relatives of Intensive Care Patients to the News of Death.
- ClinicalTrials.gov ID
- NCT04385628
- Acronym / sponsor ID
- 48670771-514.10
- Keywords
- patient death , grief reactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 29 Sep 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relatives of patients hospitalized in the intensive care unit | – | Behavioral: the patient' relatives satisfaction questionnaireDemographic 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Relatives of patients hospitalized in intensive care unit
Key inclusion criteria (2 listed)
- Apache 2 score> 25 or Expected death rate> 50%,
- Hospitalization period> 72 hours in intensive care unit -
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the patient' relatives satisfaction questionnaireThe 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. | Behavioural | Relatives of patients hospitalized in the intensive care unit |
Primary outcome
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.
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Results publication: PubMed 24082616Naik 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.
- Results publication: PubMed 10823529Jurkovich 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
selçuk Taşçı study chair
Sultan Abdulhamidhan Training Hospital
ayşın ersoy study director
Sultan Abdulhamidhan Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Effective Factors on the Grief Reactions to the Death Information, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bülent barış güven (05336383445, barguv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regular response to the bad news (time frame: From admission to discharge, up to 3 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04385628, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.