Cholecystectomy, LaparoscopicNCT07437599
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
A study testing Coffee Smell in people with Cholecystectomy, Laparoscopic, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This research was designed as a randomized controlled trial to determine the effects of coffee sniffing on pain and physiological parameters in patients undergoing cholecystectomy surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- Coffee Smell
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This research was designed as a randomized controlled trial to determine the effects of coffee sniffing on pain and physiological parameters in patients undergoing cholecystectomy surgery.
Read the 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 (numeric rating 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.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Coffee Smell, Placebo
- Keywords
- Postanesthesia Nursing, Laparoscopic Cholecystectomy, Coffee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee SmellBehavioural
The patient inhales the scent of coffee for 3-5 minutes using a cotton pad.
PlaceboBehavioural
The patient inhales an empty cotton bag for 3-5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Coffee Smelling Group | Experimental | The patient inhales the scent of coffee for 3-5 minutes using a cotton pad. Receives: Behavioral: Coffee Smell |
| Placebo Group | Placebo comparator | The patient inhales an empty cotton bag for 3-5 minutes. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Aldrete Score
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.
Measured: This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
NRS (numeric rating scale)
The Numeric Rating Scale (NRS) is a simple, closed-ended survey tool that asks respondents to assign a number to measure feelings, preferences, or symptoms. It is widely used across healthcare, market research, and customer service to translate subjective experiences into quantifiable, easy-to-analyze data. 0-10 Scale (Pain Management): The most common format. In clinical settings, the Numeric Pain Rating Scale (NPRS) asks patients to rate pain from 0 ("no pain") to 10 ("worst possible pain").
Measured: This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start22 Jan 2026
- Primary completion29 Aug 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with intervention and placebo groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Kugu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437599
- Sponsor's protocol ID
- IstanbulUC-FNHF-CH-01
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07437599
- Acronym / sponsor ID
- IstanbulUC-FNHF-CH-01
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- Postanesthesia Nursing, Laparoscopic Cholecystectomy, Coffee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 29 Aug 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research was designed as a randomized controlled trial to determine the effects of coffee sniffing on pain and physiological parameters in patients undergoing cholecystectomy surgery.
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 (numeric rating 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled trial with intervention and placebo groups.
| Arm | Type | Receives |
|---|---|---|
| Coffee Smelling Group | Experimental | Behavioral: Coffee SmellThe patient inhales the scent of coffee for 3-5 minutes using a cotton pad. |
| Placebo Group | Placebo comparator | Behavioral: PlaceboThe patient inhales an empty cotton bag for 3-5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coffee SmellThe patient inhales the scent of coffee for 3-5 minutes using a cotton pad. | Behavioural | Coffee Smelling Group |
| PlaceboThe patient inhales an empty cotton bag for 3-5 minutes. | Behavioural | Placebo Group |
Primary outcome
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.
NRS (numeric rating scale)
Time frame: This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
The Numeric Rating Scale (NRS) is a simple, closed-ended survey tool that asks respondents to assign a number to measure feelings, preferences, or symptoms. It is widely used across healthcare, market research, and customer service to translate subjective experiences into quantifiable, easy-to-analyze data. 0-10 Scale (Pain Management): The most common format. In clinical settings, the Numeric Pain Rating Scale (NPRS) asks patients to rate pain from 0 ("no pain") to 10 ("worst possible pain").
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee Smell in people with Cholecystectomy, Laparoscopic, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.