Smell Memory Method for Patients Before Surgery

NCT06414980 | Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/688
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Gallbladder; Smell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Observer Rating of Alertness and Sedayson Scale (OSS/S)

  1 day

Study Arms (2)

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.

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.

Interventions

Experimental BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those who do not accept to work,
• Having problems in smelling,
• Emergency surgeries that occur outside the daily surgery list

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Mükremin Taşın

Erzurum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TU (1)