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Behavioral Support Before Anesthesia (STØB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marianne K. Thygesen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01515683
First received: December 15, 2011
Last updated: May 5, 2014
Last verified: May 2014

December 15, 2011
May 5, 2014
December 2008
March 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
VAS score shown by patients and written down by the anesthetic nurse correcte to one decimal place.
Same as current
Complete list of historical versions of study NCT01515683 on ClinicalTrials.gov Archive Site
  • Satisfaction with help from healthcare professionals [ Time Frame: A questionnaire at discharge, an expected average of three days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Behavioral Support Before Anesthesia
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Nervousness
  • Life Experiences
  • 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
  • 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
  • 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
  • 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
  • Experimental: An anaesthetic nurse
    Intervention: Behavioral: Only support from an anaesthetic nurse on the surgery ward
  • Active Comparator: Theatre nurse + An anaesthetic nurse
    Support from theatre nurse and an anaesthetic nurse
    Intervention: Behavioral: Support: a theatre nurse + an anaesthetic nurse
  • Experimental: A nurse from ward + an anaesthesic nurse
    Support from a nurse from the ward and an anaesthetic nurse
    Intervention: Behavioral: Support: a nurse from the ward + an anaesthetic nurse
  • Experimental: Optional relative + an anaesthetic nurse
    Support from an optional relative and an anaesthetic nurse
    Intervention: Behavioral: Optional relative supports
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
May 2012
March 2012   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01515683
AA
Yes
Marianne K. Thygesen, Odense University Hospital
Odense University Hospital
Not Provided
Study Chair: Ole Mogensen, Professor Southern University of Denmark
Odense University Hospital
May 2014

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