STØB: Behavioral Support Before Anesthesia

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01515683
Collaborator
(none)
350
1
4
41
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Behavioral Support to Cancer Patients Before Anesthesia
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Care from an optional relative
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in nervousness at the operating table [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

    1. Satisfaction with help from healthcare professionals [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.

    2. Healthcare professional time spent [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marianne K. Thygesen, Development Nurse - Researcher, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT01515683
    Other Study ID Numbers:
    • AA
    First Posted:
    Jan 24, 2012
    Last Update Posted:
    May 6, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Marianne K. Thygesen, Development Nurse - Researcher, Odense University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2014