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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06414980
Other study ID # B.30.2.ATA.0.01.00/688
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date July 2024

Study information

Verified date May 2024
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date July 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Those who do not accept to work, - Having problems in smelling, - Emergency surgeries that occur outside the daily surgery list

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Experimental
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.

Locations

Country Name City State
Turkey Mükremin Tasin Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Secondary 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.
1 day
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