Skip to content

Behavioral Support Before Anesthesia

Behavioral Support to Cancer Patients Before Anesthesia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01515683
Acronym
STØB
Enrollment
350
Registered
2012-01-24
Start date
2008-12-31
Completion date
2012-05-31
Last updated
2014-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Life Experiences, Nervousness

Keywords

Nervousness before anesthesia

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.

Interventions

BEHAVIORALOnly support from an anaesthetic nurse on the surgery ward

Additional staff are only present if required by law.

BEHAVIORALSupport: 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

BEHAVIORALSupport: 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.

BEHAVIORALOptional relative supports

Optional relative follows the patient to the operating table and stays with her until she is anaesthetized

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in nervousness at the operating tableBaseline and when the patient is on the operating table, on average 1½ daysVAS score shown by patients and written down by the anesthetic nurse correcte to one decimal place.

Secondary

MeasureTime frameDescription
Satisfaction with help from healthcare professionalsA questionnaire at discharge, an expected average of three daysA 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 spentThe last half an hour before anaesthesiaHealthcare professional time spent on interventions: Healthcare professional time used with patient and relative half an hour before anaesthesia byond what is required by law

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026