Behavioral Support Before Anesthesia

Phase 2

Completed

• Conditions: Nervousness; Life Experiences
• Interventions: Behavioral: Optional relative supports; Behavioral: Only support from an anaesthetic nurse on the surgery ward

• Registration Number: NCT01515683
• Lead Sponsor: Odense University Hospital

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.

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-24
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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.

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Exclusion Criteria

• Senility

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optional relative + an anaesthetic nurse	Optional relative supports	Support from an optional relative and an anaesthetic nurse
An anaesthetic nurse	Only support from an anaesthetic nurse on the surgery ward	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Gynækologisk obstetrisk afdeling D, Odense Universitetshospital; 🇩🇰 Odense, Fyn, Denmark