Behavioral Support Before Anesthesia
STØB
Behavioral Support to Cancer Patients Before Anesthesia
1 other identifier
interventional
350
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 6, 2014
May 1, 2014
3.2 years
December 15, 2011
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in nervousness at the operating table
VAS score shown by patients and written down by the anesthetic nurse correcte to one decimal place.
Baseline and when the patient is on the operating table, on average 1½ days
Secondary Outcomes (2)
Satisfaction with help from healthcare professionals
A questionnaire at discharge, an expected average of three days
Healthcare professional time spent
The last half an hour before anaesthesia
Study Arms (4)
An anaesthetic nurse
EXPERIMENTALTheatre nurse + An anaesthetic nurse
ACTIVE COMPARATORSupport from theatre nurse and an anaesthetic nurse
A nurse from ward + an anaesthesic nurse
EXPERIMENTALSupport from a nurse from the ward and an anaesthetic nurse
Optional relative + an anaesthetic nurse
EXPERIMENTALSupport from an optional relative and an anaesthetic nurse
Interventions
Additional staff are only present if required by law.
Theatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized
A nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized.
Optional relative follows the patient to the operating table and stays with her until she is anaesthetized
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Senility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gynækologisk obstetrisk afdeling D, Odense Universitetshospital
Odense, Fyn, 5000, Denmark
Study Officials
- STUDY CHAIR
Ole Mogensen, Professor
Southern University of Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Development Nurse - Researcher
Study Record Dates
First Submitted
December 15, 2011
First Posted
January 24, 2012
Study Start
December 1, 2008
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
May 6, 2014
Record last verified: 2014-05