Behavioral Support Before Anesthesia - Full Text View

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:	252
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

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 15, 2012
Health Authority:	Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:

Nervousness before anesthesia

Additional relevant MeSH terms:

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

Behavioral Support Before Anesthesia (STØB)