- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437599
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Variables: The independent variables of the study are the participant's age, gender, height, weight, smoking, and alcohol use; the dependent variables are the length of stay in the Post-anesthesia care unit (PACU) after anesthesia, the Modified Aldrete score, the pain score (visual analogue scale), and physiological values.
Study Location and Time: This study is planned to be conducted at Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital PACU, between February 2026 and August 2026.
Study Population: The study population will consist of patients who underwent cholecystectomy surgery and received general anesthesia with the same anesthesia protocol at Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital PACU.
Data Collection Tools: A Patient Demographic Information Form, created by the researcher in accordance with the literature, will be used for data collection. The Modified Aldrete Score and the Visual Analog Scale, both valid and reliable, will be used.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Istanbul University Cerrahpasa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years of age or older,
- Having no prior history of surgery,
- Having undergone laparoscopic cholecystectomy surgery,
- Being physically and mentally able to communicate,
- Having received the same anesthesia protocol,
- Having no known allergy or sensitivity to the smell of coffee,
- Being willing and cooperative to smell coffee for the specified duration in the experimental group,
- Providing written consent after being informed about the study,
- Having an ASA I or II rating.
Exclusion Criteria:
- The following are contraindications for a patient's sense of smell:
- No complications developing during surgery,
- No indication for postoperative intensive care,
- Special circumstances (pregnancy, etc.),
- Being under active treatment for depression, anxiety, or other psychiatric disorders,
- Having anatomical abnormalities that may cause a problem with the sense of smell.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coffee Smelling Group
The patient inhales the scent of coffee for 3-5 minutes using a cotton pad.
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The patient inhales the scent of coffee for 3-5 minutes using a cotton pad.
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Placebo Comparator: Placebo Group
The patient inhales an empty cotton bag for 3-5 minutes.
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The patient inhales an empty cotton bag for 3-5 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Aldrete Score
Time Frame: This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
|
The Modified Aldrete Score is a clinical scoring system used to assess a patient's recovery and readiness for discharge from the post-anesthesia care unit (PACU) based on activity, respiration, circulation, consciousness, and oxygen saturation.
Ensures objective and standardized assessment of postoperative recovery Reduces risk of premature discharge from PACU Enhances patient safety by identifying respiratory, cardiovascular, or neurological instability Provides measurable criteria for clinical decision-making Commonly, a score of ≥ 9 indicates readiness for PACU discharge.
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This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
|
|
VAS
Time Frame: This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
|
The Visual Analog Scale (VAS) for pain is a simple tool used to measure a patient's pain intensity.
It usually consists of a 10-centimeter horizontal line with one end labeled "no pain" and the other end labeled "worst pain imaginable."
The patient marks a point on the line that represents their level of pain, and the distance from the "no pain" end is measured to determine a numerical score.
VAS is widely used in clinical practice and research because it provides a quick, subjective, and reliable assessment of pain severity.
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This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- IstanbulUC-FNHF-CH-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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