NCT04405219

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 18, 2020

Last Update Submit

May 22, 2020

Conditions

Keywords

Smoking CessationanxietypainVAS ScoresSTAI Values

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 COMPARATOR
Other: The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain

non smokers (NS)

ACTIVE COMPARATOR
Other: The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain

Interventions

Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.

non smokers (NS)smokers (S)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

Van Yuzuncu Yil University

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking CessationAnxiety DisordersPain

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arzu Esen Tekeli, MD

    yuzuncu yil

    PRINCIPAL INVESTIGATOR

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

Locations