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Behavioral Support Before Anesthesia (STØB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01515683
First Posted: January 24, 2012
Last Update Posted: May 6, 2014
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.
Information provided by (Responsible Party):
Marianne K. Thygesen, Odense University Hospital
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Behavioral Support to Cancer Patients Before Anesthesia

Resource links provided by NLM:


Further study details as provided by Marianne K. Thygesen, Odense University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 350
Study Start Date: December 2008
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Denmark
Gynækologisk obstetrisk afdeling D, Odense Universitetshospital
Odense, Fyn, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Chair: Ole Mogensen, Professor Southern University of Denmark
  More Information

Responsible Party: Marianne K. Thygesen, Development Nurse - Researcher, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01515683     History of Changes
Other Study ID Numbers: AA
First Submitted: December 15, 2011
First Posted: January 24, 2012
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Marianne K. Thygesen, Odense University Hospital:
Nervousness before anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs