Trial document




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  DRKS00023713

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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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?

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00023713
  •   2020/12/02
  •   [---]*
  •   yes
  •   Approved
  •   178/20, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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Health Condition or Problem studied

  •   prolonged grief disorder
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Interventions/Observational Groups

  •   Relatives of patients who died during the Covid-19 lockdown (period March 15 - May 31, 2020)
  •   Relatives of patients who died in the same period as arm 1, just one year later, while no contact restrictions apply
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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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)

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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?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/12/02
  •   567
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Adult relatives of deceased patients from the period 15/03/20 - 31/05/20 and 15/03/21 - 31/05/21 of the University Hospital Marburg.
Sufficient knowledge of German to participate in the survey

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
    • Mr.  Dr. med.  Christian  Volberg 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • AG Ethik in der Medizin Universitätsklinikum Marburg
    • Ms.  PD. Dr. med  Carola  Seifart 
    • Baldingerstr.
    • 35043  Marburg
    • Germany
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    • Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
    • Mr.  Dr. med.  Christian  Volberg 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
    • Mr.  Dr. med.  Christian  Volberg 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesie und Intensivmedizin Universitätsklinikum Gießen und Marburg Standort Marburg
    • Mr.  Dr. med.  Christian  Volberg 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • AG Ethik in der Medizin Universitätsklinikum Marburg
    • Ms.  PD. Dr. med  Carola  Seifart 
    • Baldingerstr.
    • 35043  Marburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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