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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04405219
Other study ID # 2018/05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 17, 2018
Est. completion date January 13, 2020

Study information

Verified date May 2020
Source Yuzuncu Yil University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 13, 2020
Est. primary completion date February 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.

Locations

Country Name City State
Turkey Van Yuzuncu Yil University Van Tusba
Turkey Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation Van Tusba

Sponsors (1)

Lead Sponsor Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety assesed with STAI form 2 hours
Secondary pain scores independent of anxiety, assesed with VAS scores 2 hours
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