AnxietyNCT01958151
Pre-procedural Anxiety and Sedation.
An observational study of Anxiety, run by Basak Ceyda MECO at 1 site in Turkey (Türkiye).
Trial summary
Colonoscopy is an outpatient procedure performed frequently as a screening test for diagnosis and treatment of a wide range of gastrointestinal problems. It is often viewed as an invasive procedure with the potential for embarrassment, discomfort, and worry. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- State-Trait Anxiety Inventory Scores
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Sep 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 75 healthy patients undergoing elective colonoscopies as a screening test.
Who may be able to join
- American Society of Anaesthesiology Physiologic assessment score I-II patients
- 18-65 years old
- planned elective colonoscopy under sedation
Who cannot join
- the use of anxiolytic medications
- history of colonic resection or any intraabdominal surgery
- predicted allergy to propofol
- patients refusing sedation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab
Ankara, 06700
About this study
Official title: Does Pre-procedural Anxiety Affect the Consumption of Sedatives During Colonoscopy?
Colonoscopy is an outpatient procedure performed frequently as a screening test for diagnosis and treatment of a wide range of gastrointestinal problems. It is often viewed as an invasive procedure with the potential for embarrassment, discomfort, and worry. Such fears can result in anxiety that may decrease the tolerance and cooperation of the patient, limit the success of the procedure, and increase the likelihood of complications. Therefore, colonoscopy is frequently performed under sedation. The anxiety level of the patient before the procedure may increase the requirement for sedation. It is important for the anesthesiologist to predict the effective dosages of sedation before the procedure to ensure rapid and comfortable sedation as well as prompt recovery and discharge of the patient.
This prospective cohort study is planned to evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for patient and surgeon satisfaction during colonoscopy.
Read the detailed description
Patients scheduled for elective colonoscopy for screening are enrolled. On the day of the procedure, demographic data are collected and all patients are asked to complete the Spielberger State-trait Anxiety Inventory (STAI-I and STAI-II) in an isolated, calm room before being transferred to the procedure room.
All patients are monitored with electrocardiogram, pulse oximetry, noninvasive blood pressure and bispectral index measurement at 5-min intervals.
Oxygen is administered at 4 L/min via a face mask, Propofol 2% infusion is started via an effect-site target controlled infusion system (Marsh model).
Once the patient reaches the desired level of sedation as determined by BIS value of 60, the procedure is started.
This monitorization and sedation protocol is the routine management of outpatient colonoscopies and gastroscopies in our institution.
For this study the patients' anxiety levels are evaluated with the STAI score. This is not an intervention but an evaluation of the patients. Drug dosing or sedation management are not adjusted according to the anxiety scores but are calculated with the patients' weight.
During the procedure:
- hemodynamic parameters
- the total propofol dosage
- the number of TCI interventions
- complications (respiratory depression, need for ventilation, nausea, vomiting, laryngospasm, and agitation)
- the procedure duration
- surgeon satisfaction with sedation instrument scores are recorded.
These collected data are studies to determine a correlation between the propofol dose and the pre-procedural anxiety of the patients.
- Conditions
- Anxiety
- Being tested
- State-Trait Anxiety Inventory Scores
- Keywords
- colonoscopy, deep sedation, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-Trait Anxiety Inventory ScoresOther
Patients are evaluated before the procedure with State-Trait Anxiety Inventory scores to determine the anxiety level.
| Study group | Role | What they receive |
|---|---|---|
| Sedated colonoscopy | Planned colonoscopies for screening under propofol sedation titrated to reach a bispectal index value of 60.
Anxiety levels are assessed before the procedure with State-Trait Anxiety Inventory Scores. Receives: Other: State-Trait Anxiety Inventory Scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for sedation during the procedure.
The sedation protocol applied in this study is our routin approach for all outpatient colonoscopies and endoscopies. All patients are informed about the procedures and monitorized (EKG, spO2, Bispectral index, blood pressure). After that, the sedation protocol is started and once the appropriate BIS value is reached the procedure is started. For this study all patients were asked to complete the STAI scores to evaluate the pre-procedural anxiety. This is not an intervention but an evaluation of the patients' anxiety. The primary outcome measure is to evaluate the dose of propofol used in each patient and to find out if there is a correlation between the pre-procedural anxiety and the dose of propofol.
Measured: The anxiety of all patients is evaluated at the day of the procedure. The procedure is then performed under sedation. Once the procedure is ended and all patients are fully awake, study data are collected and patients are discharged home.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Basak Ceyda MECO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basak Ceyda MECO, Ankara University
- Investigators
- Basak Ceyda MECO, MD, DESA, Principal investigator, Ankara University Faculty of MedicineMehmet Ayhan Kuzu, Prof, Study director, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958151
- Sponsor's protocol ID
- 10-306-12
- Status last verified
- Oct 2013
- First submitted
- 25 Sep 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pre-procedural Anxiety Affect the Consumption of Sedatives During Colonoscopy?
- ClinicalTrials.gov ID
- NCT01958151
- Acronym / sponsor ID
- 10-306-12
- Conditions
- Anxiety
- Keywords
- colonoscopy, deep sedation, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Basak Ceyda MECOUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Oct 2013 (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.
Colonoscopy is an outpatient procedure performed frequently as a screening test for diagnosis and treatment of a wide range of gastrointestinal problems. It is often viewed as an invasive procedure with the potential for embarrassment, discomfort, and worry. Such fears can result in anxiety that may decrease the tolerance and cooperation of the patient, limit the success of the procedure, and increase the likelihood of complications. Therefore, colonoscopy is frequently performed under sedation. The anxiety level of the patient before the procedure may increase the requirement for sedation. It is important for the anesthesiologist to predict the effective dosages of sedation before the procedure to ensure rapid and comfortable sedation as well as prompt recovery and discharge of the patient.
This prospective cohort study is planned to evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for patient and surgeon satisfaction during colonoscopy.
Detailed description
Patients scheduled for elective colonoscopy for screening are enrolled. On the day of the procedure, demographic data are collected and all patients are asked to complete the Spielberger State-trait Anxiety Inventory (STAI-I and STAI-II) in an isolated, calm room before being transferred to the procedure room.
All patients are monitored with electrocardiogram, pulse oximetry, noninvasive blood pressure and bispectral index measurement at 5-min intervals.
Oxygen is administered at 4 L/min via a face mask, Propofol 2% infusion is started via an effect-site target controlled infusion system (Marsh model).
Once the patient reaches the desired level of sedation as determined by BIS value of 60, the procedure is started.
This monitorization and sedation protocol is the routine management of outpatient colonoscopies and gastroscopies in our institution.
For this study the patients' anxiety levels are evaluated with the STAI score. This is not an intervention but an evaluation of the patients. Drug dosing or sedation management are not adjusted according to the anxiety scores but are calculated with the patients' weight.
During the procedure:
- hemodynamic parameters
- the total propofol dosage
- the number of TCI interventions
- complications (respiratory depression, need for ventilation, nausea, vomiting, laryngospasm, and agitation)
- the procedure duration
- surgeon satisfaction with sedation instrument scores are recorded.
These collected data are studies to determine a correlation between the propofol dose and the pre-procedural anxiety of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sedated colonoscopy | – | Other: State-Trait Anxiety Inventory ScoresPlanned colonoscopies for screening under propofol sedation titrated to reach a bispectal index value of 60. Anxiety levels are assessed before the procedure with State-Trait Anxiety Inventory Scores. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 75 healthy patients undergoing elective colonoscopies as a screening test.
Key inclusion criteria (3 listed)
- American Society of Anaesthesiology Physiologic assessment score I-II patients
- 18-65 years old
- planned elective colonoscopy under sedation
Key exclusion criteria (4 listed)
- the use of anxiolytic medications
- history of colonic resection or any intraabdominal surgery
- predicted allergy to propofol
- patients refusing sedation
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 |
|---|---|---|
| State-Trait Anxiety Inventory ScoresPatients are evaluated before the procedure with State-Trait Anxiety Inventory scores to determine the anxiety level. | Other | Sedated colonoscopy |
Primary outcome
To evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for sedation during the procedure.
Time frame: The anxiety of all patients is evaluated at the day of the procedure. The procedure is then performed under sedation. Once the procedure is ended and all patients are fully awake, study data are collected and patients are discharged home.
The sedation protocol applied in this study is our routin approach for all outpatient colonoscopies and endoscopies. All patients are informed about the procedures and monitorized (EKG, spO2, Bispectral index, blood pressure). After that, the sedation protocol is started and once the appropriate BIS value is reached the procedure is started. For this study all patients were asked to complete the STAI scores to evaluate the pre-procedural anxiety. This is not an intervention but an evaluation of the patients' anxiety. The primary outcome measure is to evaluate the dose of propofol used in each patient and to find out if there is a correlation between the pre-procedural anxiety and the dose of propofol.
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 9 Oct 2013.
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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.
Basak Ceyda MECO, MD, DESA principal investigator
Ankara University Faculty of Medicine
Mehmet Ayhan Kuzu, Prof study director
Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Basak Ceyda MECO at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 9 Oct 2013. 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 Turkey (Türkiye). 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.
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?
To evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for sedation during the procedure. (time frame: The anxiety of all patients is evaluated at the day of the procedure. The procedure is then performed under sedation. Once the procedure is ended and all patients are fully awake, study data are collected and patients are discharged home.). 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 9 Oct 2013.