NCT07437599

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress48%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

February 22, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 22, 2026

Last Update Submit

February 27, 2026

Conditions

Keywords

Postanesthesia NursingLaparoscopic CholecystectomyCoffee

Outcome Measures

Primary Outcomes (2)

  • 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.

    This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).

  • VAS

    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.

    This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).

Study Arms (2)

Coffee Smelling Group

EXPERIMENTAL

The patient inhales the scent of coffee for 3-5 minutes using a cotton pad.

Behavioral: Coffee Smell

Placebo Group

PLACEBO COMPARATOR

The patient inhales an empty cotton bag for 3-5 minutes.

Behavioral: Placebo

Interventions

Coffee SmellBEHAVIORAL

The patient inhales the scent of coffee for 3-5 minutes using a cotton pad.

Coffee Smelling Group
PlaceboBEHAVIORAL

The patient inhales an empty cotton bag for 3-5 minutes.

Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with intervention and placebo groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Student

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

February 22, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations