Prolonged grief disorder due to the Covid-19 lockdown? - Impact of contact restrictions on the relatives of patients who died during lockdown

Organizational Data

DRKS-ID:
DRKS00023713
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2020-12-02
Last update in DRKS:
2023-06-27
Registration type:
Prospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

Does the statutory ban on contact during the Covid-19 pandemic have an impact on the grief of the bereaved of patients who died in hospital during this period?

Brief summary in scientific language

The Covid-19 crisis poses a challenge for the entire world. The health sector, in particular, is dramatically overloaded in many countries and has reached the limits of treatment options. In parts of Italy it was necessary to carry out triages in order to guarantee an allocation of the available resources. In order to prevent overloading the German health system, an emergency plan was implemented from mid-March with the aim of keeping the number of infections as low as possible and enabling treatment for all patients. Measures of the emergency plan included a lockdown of social life, comprehensive hygiene measures, medical treatments only to be carried out in cases that cannot be postponed and a ban for relatives on visiting their beloved ones in hospitals. The prolonged grief disorder was included in the ICD-11 as a diagnosis by the WHO in 2019. It is a pathological grief reaction after the loss of a mostly loved one. The grief response is characterized by: - strong desire for the deceased - atypical persistence of grief (more than 6 months) - prolonged preoccupation with the deceased, accompanied by severe emotional pain (e.g. grief, guilt, denial, reproaches, feeling of having lost a part of oneself, emotional numbness, social interaction difficulties and much more). It is known that pathological grief occurs particularly often due to the sudden, unforeseen loss of a loved one, as well as tragic accompanying circumstances such as natural disasters for example. In particular, additional fears about their own existence intensify the grief reactions. During the initial phase of the pandemic and the emergency plan imposed by the government, relatives on the one hand could not be part of the dying and farewell process and, on the other hand, they might not have the opportunity to say goodbye to the deceased in the usual way after they died. In addition, the usual psychosocial support offered by pastors, psychologists and volunteer helpers in the hospitals was also missing during the lockdown. Experts therefore suspect that the pandemic and the associated deaths will also lead to an increase in prolonged grief disorders among the bereaved. First studies during Covid-19 show the presence of depressive symptoms in people in whom a relative died from Covid-19 compared to people who did not have this experience, with an effect of d = .91. How high the prevalence of the prolonged grief disorder is and whether the pathological grief is caused by the sudden loss of a relative during the Covid-19 pandemic, or the lack of accompaniment due to the imposed contact bans and the ban on visiting relatives in hospitals, is still unclear.

Health condition or problem studied

Free text:
prolonged grief disorder
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Relatives of patients who died during the Covid-19 lockdown (period March 15 - May 31, 2020)
Arm 2:
Relatives of patients who died during the second german Covid-19 lockdown (period December 13 2020 - February 28, 2021)
Arm 3:
Relatives of patients who died in the same period as arm 1, just one year later, while no contact restrictions apply

Endpoints

Primary outcome:
Did the ban on contact during the Covid-19 lockdown lead to an increase in symptoms of prolonged grief disorder as well as depressive symptoms and anxiety among the bereaved? Various questionnaires are used for this, these are listed below: 1. General information about the person 2. Information on the hospital stay and the course of the illness 3. Inventory of Complicated Grief (ICG-D) 4. General and mental constitution (HADS-D) 5. Utrecht Grief Rumination Scale (UGRS-D)
Secondary outcome:
Did the relatives feel involved in decision-making processes despite the ban on contact? Did they have the opportunity to say goodbye? Are there differences in grief between the bereaved of deceased relatives who died of a long-term illness and those who died of an acute event?

Study Design

Purpose:
Supportive care
Retrospective/prospective:
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Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
Epidemiological study

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Abteilung für Ethik in der Medizin Marburg

Recruitment period and number of participants

Planned study start date:
2020-12-02
Actual study start date:
2020-12-02
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-10-13
Target Sample Size:
1227
Final Sample Size:
135

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Adult relatives of deceased patients from the period 15/03/20 - 31/05/20 and 13/12/20 - 28/02/21 of the University Hospital Marburg. Sufficient knowledge of German to participate in the survey

Exclusion Criteria

Relatives of deceased patients who are not of legal age Relatives of non-deceased patients during the study period Insufficient knowledge of German

Addresses

Primary Sponsor

Address:
Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
Dr. med. Christian Volberg
Baldingerstraße
35043 Marburg
Germany
Telephone:
064215864934
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
Dr. med. Christian Volberg
Baldingerstraße
35043 Marburg
Germany
Telephone:
064215864934
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Address:
Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
Dr. med. Christian Volberg
Baldingerstraße
35043 Marburg
Germany
Telephone:
064215864934
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Principal Investigator

Address:
Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
Dr. med. Christian Volberg
Baldingerstraße
35043 Marburg
Germany
Telephone:
064215864934
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
Baldingerstraße
35043 Marburg
Germany
Telephone:
064215864934
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Address:
AG Ethik in der Medizin Universitätsklinikum Marburg
Baldingerstr.
35043 Marburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethikommission Fachbereich Medizin der Philipps-Universität Marburg
Baldingerstr. 1
35032 Marburg
Germany
Telephone:
+49-6421-5866487
Fax:
+49-6421-5866585
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2020-10-12
Ethics committee number:
178/20
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-11-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
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Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
von Blanckenburg P, Seifart C, Ramaswamy A, Berthold D, Volberg C. Prolonged Grief in Times of Lockdown During the COVID-19 Pandemic. Omega (Westport). 2023 Jun 8:302228231182738. doi: 10.1177/00302228231182738. Epub ahead of print. PMID: 37291862; PMCID: PMC10261962.
Date of first publication of study results:
2023-06-09
DRKS entry published for the first time with results:
2023-06-27

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry