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:
- No Entry
- 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 MarburgDr. med. Christian VolbergBaldingerstraße35043 MarburgGermany
- 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 MarburgDr. med. Christian VolbergBaldingerstraße35043 MarburgGermany
- 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 MarburgDr. med. Christian VolbergBaldingerstraße35043 MarburgGermany
- 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 MarburgDr. med. Christian VolbergBaldingerstraße35043 MarburgGermany
- 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 MarburgBaldingerstraße35043 MarburgGermany
- 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 MarburgBaldingerstr.35043 MarburgGermany
- 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 MarburgBaldingerstr. 135032 MarburgGermany
- 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
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:
- No Entry
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