Smoking Cessation, Anxiety, Pain Relationship
Preoperative Smoking Cessation, Preoperative Anxiety, Postoperative Anxiety and Pain Relationship
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2020
CompletedFirst Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedMay 28, 2020
May 1, 2020
1 year
May 18, 2020
May 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety
assesed with STAI form
2 hours
Secondary Outcomes (1)
pain scores
2 hours
Study Arms (2)
smokers (S)
SHAM COMPARATORnon smokers (NS)
ACTIVE COMPARATORInterventions
Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.
Eligibility Criteria
You may qualify if:
- ASA I,II patients
- planned Rhinoplasti cases
- accepted participating study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
Van, Tuşba, 65080, Turkey (Türkiye)
Van Yuzuncu Yil University
Van, Tuşba, 65080, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arzu Esen Tekeli, MD
yuzuncu yil
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor Doctor
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 28, 2020
Study Start
February 17, 2018
Primary Completion
February 18, 2019
Study Completion
January 13, 2020
Last Updated
May 28, 2020
Record last verified: 2020-05