- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405219
Smoking Cessation, Anxiety, Pain Relationship
Preoperative Smoking Cessation, Preoperative Anxiety, Postoperative Anxiety and Pain Relationship
Smoking, anxiety and pain are clearly related conditions. We aimed to reveal the relationship between smoking cessation before surgery and preoperative anxiety, postoperative anxiety and pain in chronic smokers.
METHODS ASA I-II group patients without chronic disease and history of drug use were included in the study. Those who did not want to participate in the study, patients with ASA III and above were excluded from the study. The patients were randomized into 2 groups: smokers (Group S, n = 60) and non-smokers (Group NS, n = 60). Group S was asked to quit smoking 2 weeks before the operation. Preoperative period and postoperative 0, 2, 4. And 6. hour Spielberger State-Trait Anxiety Inventory (STAI) values, postop 0., 2., 4., 6. hour Visual Analogue Scale (VAS) values were recorded.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tuşba
-
Van, Tuşba, Turkey, 65080
- Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
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Van, Tuşba, Turkey, 65080
- Van Yüzüncü Yil University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I,II patients
- planned Rhinoplasti cases
- accepted participating study
Exclusion Criteria:
- Patients with chronic systemic disorders,
- ASA III and above situation
- emergency and bleeding cases,
- patients with any cardiac and neurological disorders,
- refused to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: smokers (S)
|
Preoperative anxiety high score suggests stress related to surgery and anesthesia.
High anxiety scores independent of post-operative pain showed smoking withdrawal.
|
ACTIVE_COMPARATOR: non smokers (NS)
|
Preoperative anxiety high score suggests stress related to surgery and anesthesia.
High anxiety scores independent of post-operative pain showed smoking withdrawal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: 2 hours
|
assesed with STAI form
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain scores
Time Frame: 2 hours
|
independent of anxiety, assesed with VAS scores
|
2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arzu Esen Tekeli, MD, yuzuncu yil
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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