NervousnessPhase 2STØBNCT01515683
Behavioral Support Before Anesthesia
A Phase 2 study testing Only support from an anaesthetic nurse on the surgery ward, Support: a theatre nurse + an anaesthetic nurse and Support: a nurse from the ward + an anaesthetic nurse in people with Nervousness and Life Experiences, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Nervousness, Life Experiences
- What is being tested?
- Only support from an anaesthetic nurse on the surgery ward, Support: a theatre nurse + an anaesthetic nurse and Support: a nurse from the ward + an anaesthetic nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2008to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Senility
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gynækologisk obstetrisk afdeling D, Odense Universitetshospital
Odense, Fyn, 5000
About this study
Official title: Behavioral Support to Cancer Patients 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.
Read the 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.
- Conditions
- Nervousness, Life Experiences
- Being tested
- Only support from an anaesthetic nurse on the surgery ward, Support: a theatre nurse + an anaesthetic nurse, Support: a nurse from the ward + an anaesthetic nurse, Optional relative supports
- Keywords
- Nervousness before anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only support from an anaesthetic nurse on the surgery wardBehavioural
Also called Nursing care from an anaesthetic nurse
Additional staff are only present if required by law.
Support: a theatre nurse + an anaesthetic nurseBehavioural
Also called Care from a theatre nurse
Theatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized
Support: a nurse from the ward + an anaesthetic nurseBehavioural
Also called Nursing care from a ward nurse
A nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized.
Optional relative supportsBehavioural
Also called Care from an optional relative
Optional relative follows the patient to the operating table and stays with her until she is anaesthetized
| Study group | Role | What they receive |
|---|---|---|
| An anaesthetic nurse | Experimental | Not described Receives: Behavioral: Only support from an anaesthetic nurse on the surgery ward |
| Theatre nurse + An anaesthetic nurse | Active comparator | Support from theatre nurse and an anaesthetic nurse Receives: Behavioral: Support: a theatre nurse + an anaesthetic nurse |
| A nurse from ward + an anaesthesic nurse | Experimental | Support from a nurse from the ward and an anaesthetic nurse Receives: Behavioral: Support: a nurse from the ward + an anaesthetic nurse |
| Optional relative + an anaesthetic nurse | Experimental | Support from an optional relative and an anaesthetic nurse Receives: Behavioral: Optional relative supports |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and when the patient is on the operating table, on average 1½ days
Secondary outcomes (2)
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.
Measured: 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
Measured: The last half an hour before anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startDec 2008
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NervousnessStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne K. Thygesen, Odense University Hospital
- Investigators
- Ole Mogensen, Professor, Study chair, Southern University of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515683
- Sponsor's protocol ID
- AA
- Acronym
- STØB
- Status last verified
- May 2014
- First submitted
- 15 Dec 2011
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Support to Cancer Patients Before Anesthesia
- ClinicalTrials.gov ID
- NCT01515683
- Acronym / sponsor ID
- STØB / AA
- Conditions
- Nervousness, Life Experiences
- Keywords
- Nervousness before anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| An anaesthetic nurse | Experimental | Behavioral: Only support from an anaesthetic nurse on the surgery ward |
| Theatre nurse + An anaesthetic nurse | Active comparator | Behavioral: Support: a theatre nurse + an anaesthetic nurseSupport from theatre nurse and an anaesthetic nurse |
| A nurse from ward + an anaesthesic nurse | Experimental | Behavioral: Support: a nurse from the ward + an anaesthetic nurseSupport from a nurse from the ward and an anaesthetic nurse |
| Optional relative + an anaesthetic nurse | Experimental | Behavioral: Optional relative supportsSupport from an optional relative and an anaesthetic nurse |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Senility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Only support from an anaesthetic nurse on the surgery wardAlso: Nursing care from an anaesthetic nurseAdditional staff are only present if required by law. | Behavioural | An anaesthetic nurse |
| Support: a theatre nurse + an anaesthetic nurseAlso: Care from a theatre nurseTheatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized | Behavioural | Theatre nurse + An anaesthetic nurse |
| Support: a nurse from the ward + an anaesthetic nurseAlso: Nursing care from a ward nurseA nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized. | Behavioural | A nurse from ward + an anaesthesic nurse |
| Optional relative supportsAlso: Care from an optional relativeOptional relative follows the patient to the operating table and stays with her until she is anaesthetized | Behavioural | Optional relative + an anaesthetic nurse |
Primary outcome
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.
2 secondary outcomes
Satisfaction with help from healthcare professionals
Time frame: A questionnaire at discharge, an expected average of three days
Healthcare professional time spent
Time frame: The last half an hour before anaesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Mogensen, Professor study chair
Southern University of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Only support from an anaesthetic nurse on the surgery ward, Support: a theatre nurse + an anaesthetic nurse and Support: a nurse from the ward + an anaesthetic nurse in people with Nervousness and Life Experiences, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.