Behavioral Support Before Anesthesia (STØB)
Behavioral Support to Cancer Patients Before Anesthesia
Studies shows that reduced nervousness before anaesthesia may improve a course past anaesthesia. Therefore it is interesting to investigate how we can best help patients shortly before anaesthesia. A RCT with three intervention arms (with different personal support) and a control arm (with usual personal support) is therefore performed.
Hypothesis: Nervousness is reduced by the new interventions compared to the usual help provided.
Study Overview
Status
Conditions
Detailed Description
All patients receive behavioral support the last half hour before anaesthesia, but at different times and provided by persons with different connection to the patients.
The last two patients in all arms will be interviewed about their experiences with the help offered.
Statistic will provide results in the quantitative part of the study and analysis and interpretation following ideas of the French philosopher Poul Ricoeur will provide results in the qualitative part of the study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Fyn
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Odense, Fyn, Denmark, 5000
- Gynækologisk obstetrisk afdeling D, Odense Universitetshospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All Danish-speaking expected gynaecological cancer patients, who are offered open surgery at Odense University Hospital, who can speak for themselves and have the opportunity to have close relative to follow before anaesthesia and who accept participation.
Exclusion Criteria:
- Senility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: An anaesthetic nurse
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Additional staff are only present if required by law.
Other Names:
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Active Comparator: Theatre nurse + An anaesthetic nurse
Support from theatre nurse and an anaesthetic nurse
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Theatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized
Other Names:
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Experimental: A nurse from ward + an anaesthesic nurse
Support from a nurse from the ward and an anaesthetic nurse
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A nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized.
Other Names:
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Experimental: Optional relative + an anaesthetic nurse
Support from an optional relative and an anaesthetic nurse
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Optional relative follows the patient to the operating table and stays with her until she is anaesthetized
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in nervousness at the operating table
Time Frame: Baseline and when the patient is on the operating table, on average 1½ days
|
VAS score shown by patients and written down by the anesthetic nurse correcte to one decimal place.
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Baseline and when the patient is on the operating table, on average 1½ days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with help from healthcare professionals
Time Frame: A questionnaire at discharge, an expected average of three days
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A validated questionnaire is filed out by patients.
The questionnaire have six items measuring satisfaction with help from healthcare professionals provided at the hospital.
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A questionnaire at discharge, an expected average of three days
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|
Healthcare professional time spent
Time Frame: The last half an hour before anaesthesia
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Healthcare professional time spent on interventions: Healthcare professional time used with patient and relative half an hour before anaesthesia byond what is required by law
|
The last half an hour before anaesthesia
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ole Mogensen, Professor, Southern University of Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA
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