Smoking Cessation, Anxiety, Pain Relationship
Primary Purpose
Smoking Cessation, Anxiety, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
Sponsored by
About this trial
This is an interventional other trial for Smoking Cessation focused on measuring Smoking Cessation, anxiety, pain, VAS Scores, STAI Values
Eligibility Criteria
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
Sites / Locations
- Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
- Van Yuzuncu Yil University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
smokers (S)
non smokers (NS)
Arm Description
Outcomes
Primary Outcome Measures
Anxiety
assesed with STAI form
Secondary Outcome Measures
pain scores
independent of anxiety, assesed with VAS scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04405219
Brief Title
Smoking Cessation, Anxiety, Pain Relationship
Official Title
Preoperative Smoking Cessation, Preoperative Anxiety, Postoperative Anxiety and Pain Relationship
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 17, 2018 (Actual)
Primary Completion Date
February 18, 2019 (Actual)
Study Completion Date
January 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
it has been revealed in the current study that smoking, pain and anxiety are interrelated with each other. In the preoperative period, high anxiety scores are related to surgery and anesthesia stress. High anxiety scores in the smoker group both in the preoperative period and in the postoperative period are associated with smoking cessation. While the pain scores were similar in the postoperative period, high anxiety scores strengthened the idea of smoking withdrawal and this study gained value. We believe that future studies with a large number of patients, with different parameters and multiple centers will strengthen the results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Anxiety, Pain
Keywords
Smoking Cessation, anxiety, pain, VAS Scores, STAI Values
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
smokers (S)
Arm Type
Sham Comparator
Arm Title
non smokers (NS)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
Intervention Description
Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.
Primary Outcome Measure Information:
Title
Anxiety
Description
assesed with STAI form
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
pain scores
Description
independent of anxiety, assesed with VAS scores
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Esen Tekeli, MD
Organizational Affiliation
yuzuncu yil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey
Facility Name
Van Yuzuncu Yil University
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
I do not want to share before publishing
Learn more about this trial
Smoking Cessation, Anxiety, Pain Relationship
We'll reach out to this number within 24 hrs