Behavioral Support Before Anesthesia

NCT ID: NCT01515683

Last Updated: 2014-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-05-31

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.

Conditions

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Nervousness Life Experiences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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An anaesthetic nurse

Group Type EXPERIMENTAL

Only support from an anaesthetic nurse on the surgery ward

Intervention Type BEHAVIORAL

Additional staff are only present if required by law.

Theatre nurse + An anaesthetic nurse

Support from theatre nurse and an anaesthetic nurse

Group Type ACTIVE_COMPARATOR

Support: a theatre nurse + an anaesthetic nurse

Intervention Type BEHAVIORAL

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

A nurse from ward + an anaesthesic nurse

Support from a nurse from the ward and an anaesthetic nurse

Group Type EXPERIMENTAL

Support: a nurse from the ward + an anaesthetic nurse

Intervention Type BEHAVIORAL

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

Optional relative + an anaesthetic nurse

Support from an optional relative and an anaesthetic nurse

Group Type EXPERIMENTAL

Optional relative supports

Intervention Type BEHAVIORAL

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

Interventions

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Only support from an anaesthetic nurse on the surgery ward

Additional staff are only present if required by law.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Optional relative supports

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Nursing care from an anaesthetic nurse Care from a theatre nurse Nursing care from a ward nurse Care from an optional relative

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne K. Thygesen

Development Nurse - Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ole Mogensen, Professor

Role: STUDY_CHAIR

Southern University of Denmark

Locations

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Gynækologisk obstetrisk afdeling D, Odense Universitetshospital

Odense, Fyn, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AA

Identifier Type: -

Identifier Source: org_study_id

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