Behavioral Support Before Anesthesia

Life Experiences Clinical Trial

— STØB  

Official title:

Behavioral Support to Cancer Patients Before Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515683
• Other study ID #: AA
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2011
• Last updated: May 5, 2014
• Start date: December 2008
• Est. completion date: May 2012

Study information

• Verified date: May 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Life Experiences
• Nervousness

Intervention

Behavioral:
• Only support from an anaesthetic nurse on the surgery ward
Additional staff are only present if required by law.
• 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
• 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.
• Optional relative supports
Optional relative follows the patient to the operating table and stays with her until she is anaesthetized

Locations

Country	Name	City	State
Denmark	Gynækologisk obstetrisk afdeling D, Odense Universitetshospital	Odense	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in nervousness at the operating table	VAS score shown by patients and written down by the anesthetic nurse correcte to one decimal place.	Baseline and when the patient is on the operating table, on average 1½ days	No
Secondary	Satisfaction with help from healthcare professionals	A validated questionnaire is filed out by patients. The questionnaire have six items measuring satisfaction with help from healthcare professionals provided at the hospital.	A questionnaire at discharge, an expected average of three days	No
Secondary	Healthcare professional time spent	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	The last half an hour before anaesthesia	No