SurgeryNCT06414980
Smell Memory Method for Patients Before Surgery
A study testing Experimental in people with Surgery and Gallbladder, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The research is planned as a randomized controlled experimental at Erzurum Atatürk University Health Application and Research Center. The population of the research will include patients who come to the General Surgery Gastroenterology service for laparoscopic cholecystectomy between the specified dates and who meet… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Gallbladder, Smell
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Students who do not have communication barriers or hearing, speaking or perception problems will participate in the research.
- Those who are over 18 years of age and under 80 years of age,
- Will participate in the study voluntarily,
- Those who will undergo elective laparoscopic cholecystectomy surgery,
- Operation duration of 1 hour or more,
- General anesthesia will be applied,
- Patients without chronic loss of smell
Who cannot join
- Those who do not accept to work,
- Having problems in smelling,
- Emergency surgeries that occur outside the daily surgery list
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mükremin Taşın
Erzurum
Mükremin TAŞKIN, +905395150257, mukremin.taskin@atauni.edu.tr
About this study
Official title: Examining the Effect of the Suggestion Given to Patients With the Olfactory Memory Method Before the Surgical Operation on the Vital Signs and Systemic Evaluation Scoring During Awakening.
The research is planned as a randomized controlled experimental at Erzurum Atatürk University Health Application and Research Center.
The population of the research will include patients who come to the General Surgery Gastroenterology service for laparoscopic cholecystectomy between the specified dates and who meet the criteria for inclusion in the study. In this research, 30 experimental and 30 control group patients will be included in the study in order to perform parametric tests.
Read more
The data of the research were prepared by the researcher using the literature and similar studies after obtaining ethics committee approval and written permission from the institution where the research would be conducted. "FR.3- Alertness and Sedation Observer Assessment Scale (OAA/S)" and Modified Aldrete Scoring, Awake and Sedation Observer Assessment Scale and "FR.4- MAS and OAA/S Scores Time-Dependent", which includes the Patient's Vital Signs, are used to evaluate the patient's condition. Patients determined by the "Change Table" will be collected by observing them before and after surgery.
In the research; In order to more easily overcome the anxiety and confusion that patients who have undergone surgical operations experience during the orientation process while waking up after the case, the patient will be given suggestions regarding the post-anesthesia waking period by testing the menthol smell in the preoperative period. When the patient hears the menthol scent applied during postoperative awakening; It is intended for the patient to remember that his surgery is over, that he needs to wake up and that the medical staff is waiting for him to wake up. In this way, it is thought that the patient's anxiety and complexity during the postoperative awakening period will be eliminated, the patient's vital signs will remain at an optimum level, and a more comfortable reanimation will occur.
- Conditions
- Surgery, Gallbladder, Smell
- Being tested
- Experimental
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
The effect of suggestion given to patients with the olfactory memory method before the surgical operation on vital signs and systemic evaluation scoring during awakening.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | On the day of the operation, patients will be given a menthol scent before the surgery. Data collection forms will be applied to the experimental group at specified intervals on the day of operation, at the clinic exit, before surgery, after surgery and in the recovery room (PACU). The day after the operation, a final interview will be held with the experimental group patients and questions will be asked about their experiences during the post-operative awakening process and these will be recorded. Receives: Behavioral: Experimental |
| Control | No intervention | In the control group, which did not undergo any intervention, at the clinic exit on the day of the operation, vital values (pulse, blood pressure) were recorded at preoperative, postoperative and recovery room (PACU) intervals (Unit entrance, 5th minute, 10th minute, 15th minute and 20th minute). , body temperature, blood pressure and SpO2) will be taken. At the same time, the Modified Aldrete Score (MAS) and the Alertness and Sedation Observer Rating Scale (OSS/S) will be independently evaluated and recorded by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Aldrete Score
The Aldrete score was first described in 1970 by Dr Antonio Aldrete as an analogue of Apgar scoring. This scoring system examines muscle activity, respiration, blood pressure, consciousness and skin color, with each given 0, 1 or 2 points, giving a maximum score of 10. Patients with a total score of 8 or above can be easily sent from the recovery room. The Modified Aldrete Scoring has become widely accepted in assessing postanesthetic recovery. It has been widely used in many postanesthesia care units41 since its description. When the Modified Aldrete Score is calculated as 9 or above, it indicates that patients are adequately prepared for transfer from the postanesthesia care unit to the service. Today, organizations such as the Canadian Association of Anesthesiologists, the Joint Commission on Accreditation of Healthcare Organizations, and the Ontario Perianesthesia Nurses Association recommend the use of the Modified Aldrete Scoring.
Measured: 1 day
Secondary outcomes (1)
Observer Rating of Alertness and Sedayson Scale (OSS/S)
The Alertness and Sedation Observer Assessment Scale (OAA/S) is a scoring system used to evaluate the alertness state in patients. In today's anesthesia practices, the OAA/S score is widely used to evaluate the level of consciousness suppression of hypnotic drugs and the alertness of patients.
The OAA/S score was first introduced by Chernik et al. in 1990. This scoring system is an evaluation based on scoring the patient's response between 0-5. The patient's reaction status is examined, starting with calling the patient in a normal tone of voice, progressing to light poking and shaking, and if necessary, giving painful stimuli (squeezing the trapezius). Patients with scores of 5-4-3 are considered responsive, while patients with scores of 0-1 are considered unresponsive. Patients with scores between 2 and 3 are considered to have loss of consciousness.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mükremin Taşkın, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414980
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/688
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of the Suggestion Given to Patients With the Olfactory Memory Method Before the Surgical Operation on the Vital Signs and Systemic Evaluation Scoring During Awakening.
- ClinicalTrials.gov ID
- NCT06414980
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/688
- Conditions
- Surgery, Gallbladder, Smell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 16 May 2024 (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.
The research is planned as a randomized controlled experimental at Erzurum Atatürk University Health Application and Research Center.
The population of the research will include patients who come to the General Surgery Gastroenterology service for laparoscopic cholecystectomy between the specified dates and who meet the criteria for inclusion in the study. In this research, 30 experimental and 30 control group patients will be included in the study in order to perform parametric tests.
The data of the research were prepared by the researcher using the literature and similar studies after obtaining ethics committee approval and written permission from the institution where the research would be conducted. "FR.3- Alertness and Sedation Observer Assessment Scale (OAA/S)" and Modified Aldrete Scoring, Awake and Sedation Observer Assessment Scale and "FR.4- MAS and OAA/S Scores Time-Dependent", which includes the Patient's Vital Signs, are used to evaluate the patient's condition. Patients determined by the "Change Table" will be collected by observing them before and after surgery.
In the research; In order to more easily overcome the anxiety and confusion that patients who have undergone surgical operations experience during the orientation process while waking up after the case, the patient will be given suggestions regarding the post-anesthesia waking period by testing the menthol smell in the preoperative period. When the patient hears the menthol scent applied during postoperative awakening; It is intended for the patient to remember that his surgery is over, that he needs to wake up and that the medical staff is waiting for him to wake up. In this way, it is thought that the patient's anxiety and complexity during the postoperative awakening period will be eliminated, the patient's vital signs will remain at an optimum level, and a more comfortable reanimation will occur.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: ExperimentalOn the day of the operation, patients will be given a menthol scent before the surgery. Data collection forms will be applied to the experimental group at specified intervals on the day of operation, at the clinic exit, before surgery, after surgery and in the recovery room (PACU). The day after the operation, a final interview will be held with the experimental group patients and questions will be asked about their experiences during the post-operative awakening process and these will be recorded. |
| Control | No intervention | –In the control group, which did not undergo any intervention, at the clinic exit on the day of the operation, vital values (pulse, blood pressure) were recorded at preoperative, postoperative and recovery room (PACU) intervals (Unit entrance, 5th minute, 10th minute, 15th minute and 20th minute). , body temperature, blood pressure and SpO2) will be taken. At the same time, the Modified Aldrete Score (MAS) and the Alertness and Sedation Observer Rating Scale (OSS/S) will be independently evaluated and recorded by the researcher. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Students who do not have communication barriers or hearing, speaking or perception problems will participate in the research.
- Those who are over 18 years of age and under 80 years of age,
- Will participate in the study voluntarily,
- Those who will undergo elective laparoscopic cholecystectomy surgery,
- Operation duration of 1 hour or more,
Key exclusion criteria (3 listed)
- Those who do not accept to work,
- Having problems in smelling,
- Emergency surgeries that occur outside the daily surgery list
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 |
|---|---|---|
| ExperimentalThe effect of suggestion given to patients with the olfactory memory method before the surgical operation on vital signs and systemic evaluation scoring during awakening. | Behavioural | Experimental |
Primary outcome
Modified Aldrete Score
Time frame: 1 day
The Aldrete score was first described in 1970 by Dr Antonio Aldrete as an analogue of Apgar scoring. This scoring system examines muscle activity, respiration, blood pressure, consciousness and skin color, with each given 0, 1 or 2 points, giving a maximum score of 10. Patients with a total score of 8 or above can be easily sent from the recovery room. The Modified Aldrete Scoring has become widely accepted in assessing postanesthetic recovery. It has been widely used in many postanesthesia care units41 since its description. When the Modified Aldrete Score is calculated as 9 or above, it indicates that patients are adequately prepared for transfer from the postanesthesia care unit to the service. Today, organizations such as the Canadian Association of Anesthesiologists, the Joint Commission on Accreditation of Healthcare Organizations, and the Ontario Perianesthesia Nurses Association recommend the use of the Modified Aldrete Scoring.
1 secondary outcome
Observer Rating of Alertness and Sedayson Scale (OSS/S)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Related trials for Surgery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Surgery and Gallbladder, run by Ataturk University 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Aldrete Score (time frame: 1 day). 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 16 May 2024.