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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Behavioral Support to Cancer Patients Before Anesthesia

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ 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


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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marianne K. Thygesen, Development Nurse - Researcher, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01515683     History of Changes
Other Study ID Numbers: AA
Study First Received: December 15, 2011
Last Updated: May 5, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Nervousness before anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014