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Completed

NCT Number: NCT01515683

Behavioral Support Before Anesthesia

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.

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Key information

Conditions

Nervousness Life Experiences

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gynækologisk obstetrisk afdeling D, Odense Universitetshospital

Odense, Fyn, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Only support from an anaesthetic nurse on the surgery ward

Behavioral

Additional staff are only present if required by law.

Other names: Nursing care from an anaesthetic nurse

Support: a theatre nurse + an anaesthetic nurse

Behavioral

Theatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized

Other names: Care from a theatre nurse

Support: a nurse from the ward + an anaesthetic nurse

Behavioral

A nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized.

Other names: Nursing care from a ward nurse

Optional relative supports

Behavioral

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

Other names: Care from an optional relative

Primary outcomes

  1. 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

    VAS score shown by patients and written down by the anesthetic nurse correcte to one decimal place.

Secondary outcomes

  1. Satisfaction with help from healthcare professionals

    Time frame: 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.

  2. Healthcare professional time spent

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Behavioral Support to Cancer Patients Before Anesthesia

Acronym: STØB

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 24, 2012
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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