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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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8 May 2017 |
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Main ID: |
ACTRN12617000569303 |
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Date of registration:
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24/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluating the role of a diary in new onset stress,anxiety, depression and post traumatic stress disorder in relatives of patients in the intensive care unit
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Scientific title:
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Psychological support for relatives of patients in the intensive care unit using diaries- an exploratory study |
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Date of first enrolment:
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1/07/2015 |
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Target sample size:
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100 |
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Recruitment status: |
Stopped early |
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URL:
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http://www.anzctr.org.au/ACTRN12617000569303.aspx |
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Study type:
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Interventional |
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Study design:
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Non-randomised trial
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Phase:
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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Post-traumatic Stress Disorder ( PTSD)
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ANXIETY
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Stress
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Intervention(s)
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Family members of 100 consecutive patients admitted to the Royal Adelaide Hospital
Intensive Care Unit and remaining in the unit for 48hrs or more will be identified.
On day 3 of admission family members will be approached by the research team and asked to identify a primary next of kin or decision maker. This person will then be approached to participate in the study.The study will be explained to them and they will be asked if they consent to participate.
The diary is a free flowing manuscript that portrays the patient’s journey in a critical care environment. It has headings/ templates to be completed, and contains key points for the person writing in it. This is included under the title ‘this is me” and gives an opportunity for us to know the patient better. By divulging all possible information about the patient, we believe the relative is likely to be less stressed and this will hopefully impact on the incidence of PTSD. The diary does have a preamble and includes guidelines on how each entry should be written.
The family members were given the opportunity to contribute to the diary with photographs, testimonials and vignettes. Medical input was limited unless specifically requested by the patient’s relative. The diary was identified as “complete” only if it had an entry on every day of their ICU stay either by the family member or by the nurse. Family members were given an opportunity to document in the diary retrospectively, if they were unable to be present on a particular day.
During their stay in the ICU, the family members were encouraged to express their feelings in writing in the diary. At the time of discharge from the ICU, the diary was hand-delivered.by the Investigator to the designated family member. Family members who chose not to fill in diaries were compared to those who had. At 90 days post discharge of the patient from ICU, all the participants were telephoned to go through the IES-R and DASS21 questionnaires again.
A separate consent form will be provided. There will be a declination form given to the
consenting next of kin at the time of obtaining consent to give them the opportunity to
withdraw consent if their circumstances change. Even before the commencement of the
telephonic interview the interviewer will ask for a verbal consent before proceeding with
the questionnaire. In the event of the next of kin disagreeing to participate in the
interview, the interview will be abandoned.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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