Behavioral Support Before Anesthesia (STØB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01515683|
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : May 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Nervousness Life Experiences||Behavioral: Only support from an anaesthetic nurse on the surgery ward Behavioral: Support: a theatre nurse + an anaesthetic nurse Behavioral: Support: a nurse from the ward + an anaesthetic nurse Behavioral: Optional relative supports||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Behavioral Support to Cancer Patients Before Anesthesia|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||May 2012|
|Experimental: An anaesthetic nurse||
Behavioral: Only support from an anaesthetic nurse on the surgery ward
Additional staff are only present if required by law.
Other Name: Nursing care from an anaesthetic nurse
Active Comparator: Theatre nurse + An anaesthetic nurse
Support from theatre nurse and an anaesthetic nurse
Behavioral: Support: a theatre nurse + an anaesthetic nurse
Theatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized
Other Name: Care from a theatre nurse
Experimental: A nurse from ward + an anaesthesic nurse
Support from a nurse from the ward and an anaesthetic nurse
Behavioral: Support: a nurse from the ward + an anaesthetic nurse
A nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized.
Other Name: Nursing care from a ward nurse
Experimental: Optional relative + an anaesthetic nurse
Support from an optional relative and an anaesthetic nurse
Behavioral: Optional relative supports
Optional relative follows the patient to the operating table and stays with her until she is anaesthetized
Other Name: Care from an optional relative
- 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.
- Satisfaction with help from healthcare professionals [ Time Frame: A questionnaire at discharge, an expected average of three days ]A validated questionnaire is filed out by patients. The questionnaire have six items measuring satisfaction with help from healthcare professionals provided at the hospital.
- Healthcare professional time spent [ Time Frame: The last half an hour before anaesthesia ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515683
|Gynækologisk obstetrisk afdeling D, Odense Universitetshospital|
|Odense, Fyn, Denmark, 5000|
|Study Chair:||Ole Mogensen, Professor||Southern University of Denmark|