Cardiopulmonary Resuscitation Witnessing by a Relative (PRESENCE)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01009606
First received: November 6, 2009
Last updated: January 17, 2013
Last verified: December 2012

November 6, 2009
January 17, 2013
November 2009
December 2011   (final data collection date for primary outcome measure)
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01009606 on ClinicalTrials.gov Archive Site
  • Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG) [ Time Frame: 3 and 12 months ] [ Designated as safety issue: Yes ]
  • Psychological follow-up [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Suicide [ Time Frame: 3 and 12 months ] [ Designated as safety issue: Yes ]
  • Medico-legal recourse [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quality of the cardiopulmonary resuscitation [ Time Frame: day 0 ] [ Designated as safety issue: Yes ]
  • Questionnaire evaluating the stress of the medical and paramedical team [ Time Frame: day 0 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cardiopulmonary Resuscitation Witnessing by a Relative
Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest

The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.

This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:

Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.

Control group: the medical team will not modify its usual management of care.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiac Arrest
  • Other: Usual strategy
    Usual strategy
  • Other: Modified strategy
    Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation
  • Active Comparator: Arm 1 : Control : usual strategy
    Intervention: Other: Usual strategy
  • Experimental: Arm 2: Comparator : modified strategy
    Intervention: Other: Modified strategy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
570
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient victim of a cardiac arrest and resuscitation initiated
  • Occurrence of cardiac arrest at home
  • Presence of a relative :

    • husband or spouse
    • father or mother
    • son or daughter
    • brother or sister
  • Patient's age ≥ 18 years
  • Relative's age ≥ 18 years
  • Consent of the relative to the participation in the study

Exclusion Criteria:

  • No understanding of the explanations (language problem, important agitation)
  • Non-affiliated to social security
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01009606
P071239
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Principal Investigator: Frédéric ADNET, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP