Behavioral Support Before Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Behavioral Support to Cancer Patients Before Anesthesia

Conditions
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Nervousness, Life Experiences

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: An anaesthetic nurse<br> | Behavioral: Only support from an anaesthetic nurse on the surgery ward<br>* Additional staff are only present if required by law.<br>* Other names: Nursing care from an anaesthetic nurse;|
| Active Comparator: Theatre nurse + An anaesthetic nurse<br>Support from theatre nurse and an anaesthetic nurse | Behavioral: Support: a theatre nurse + an anaesthetic nurse<br>* Theatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized<br>* Other names: Care from a theatre nurse;|
| Experimental: A nurse from ward + an anaesthesic nurse<br>Support from a nurse from the ward and an anaesthetic nurse | Behavioral: Support: a nurse from the ward + an anaesthetic nurse<br>* A nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized.<br>* Other names: Nursing care from a ward nurse;|
| Experimental: Optional relative + an anaesthetic nurse<br>Support from an optional relative and an anaesthetic nurse | Behavioral: Optional relative supports<br>* Optional relative follows the patient to the operating table and stays with her until she is anaesthetized<br>* Other names: Care from an optional relative;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nervousness before anesthesia