Protocol summary

Study aim
Determining and comparing the effect of aromatherapy with peppermint and rosemary essential oils on memory function and anxiety of operating room technology and anesthesia students
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 90 patients. Sealed envelopes will be used for randomization
Settings and conduct
On the first day of the intervention, a cotton ball dipped in two drops of peppermint oil or rosemary oil or a placebo (distilled water) will be presented to the participant and then asked to place it at a distance of 5 cm from the nose. They breathe deeply for 15 minutes slowly and focusing on the smell of essential oil. The interventions will be repeated in the same way for 2 weeks (4 times a week) (8 sessions in total). Finally, after the end of the interventions, the evaluations including memory performance and anxiety will be completed on the morning of the 15th day using questionnaires, and the person who analyzes the results will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: passing at least one unit of internship in the operating room (semester 2 and above); not allergic to peppermint and rosemary essential oil; absence of cardiovascular, respiratory, neurological or psychiatric disorders based on self-report. Exclusion criteria: participating in an aromatherapy study now; taking any medication that affects memory and anxiety; absence of the person during intervention sessions; occurrence of any allergic reaction, shortness of breath or sudden change in hemodynamic status.
Intervention groups
The participant will be presented with a cotton ball dipped in two drops of peppermint oil or rosemary oil or a placebo (distilled water) and then asked to place it 5 cm away from the nos. Participants breathe deeply for 15 minutes, slowly focusing on the scent of the essential oil.
Main outcome variables
Memory function and anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200206046395N6
Registration date: 2024-11-27, 1403/09/07
Registration timing: prospective

Last update: 2024-11-27, 1403/09/07
Update count: 0
Registration date
2024-11-27, 1403/09/07
Registrant information
Name
Mobin Mottahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3233 8090
Email address
mobinmottahedi1372@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-10, 1403/09/20
Expected recruitment end date
2025-12-11, 1404/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the effect of aromatherapy with peppermint and rosemary essential oils on memory function and anxiety of operating room technology and anesthesia students
Public title
Investigating and comparing the effect of aromatherapy with peppermint and rosemary essential oils on memory function and anxiety of operating room technology and anesthesia students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Passing at least one course of internship in the operating room (semester 2 and above) Not allergic to peppermint and rosemary essential oil Absence of cardiovascular, respiratory, neurological or psychiatric disorders based on self-report
Exclusion criteria:
Participating in an aromatherapy study now Taking any medication that affects memory and anxiety Absence of the person during intervention sessions Occurrence of any allergic reaction, shortness of breath or sudden change in hemodynamic status
Age
From 19 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization sequence: The randomization sequence will be established by a statistician who is not involved in participant enrollment or assignment to interventions. Participant enrollment: Participants will be enrolled by a research assistant who is aware of inclusion and exclusion criteria but blind to group assignments. Allocation of interventions: After registration, the participant will be assigned to the peppermint essential oil group, the rosemary essential oil group, or the control based on the sequence determined by the sealed envelope method. Meanwhile, the research assistant opens the sealed envelope related to the participant's registration number.
Blinding (investigator's opinion)
Single blinded
Blinding description
The individual involved in data collection and outcome assessment is intentionally blinded to the allocation of participants (e.g., intervention or control group) to minimize the potential for bias affecting the study results.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrood University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2024-11-10, 1403/08/20
Ethics committee reference number
IR.SHMU.REC.1403.137

Health conditions studied

1

Description of health condition studied
Anxiety disorder, unspecified
ICD-10 code
F41.9
ICD-10 code description
Anxiety NOS

2

Description of health condition studied
Other amnesia
ICD-10 code
R41.3
ICD-10 code description
Amnesia NOS

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention (morning of the first day) - after the last session of interventions (15th day)
Method of measurement
Questionnaire Beck Anxiety Inventory

2

Description
Memory function
Timepoint
Before intervention (morning of the first day) - after the last session of interventions (15th day)
Method of measurement
Questionnaire Prospective and Retrospective Memory Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: On the first day of the intervention, a cotton ball dipped in two drops of peppermint oil will be presented to the participant and then he will be asked to place it at a distance of 5 cm from the nose. This intervention will be done as the first aromatherapy session in the operating room in a private room shortly before the student's internship (7:30-7:45 in the morning). In addition, the essential oil used in this research is 100% pure. Peppermint essential oil is produced by Shafa Herbs Company (Kurdistan, Iran). The ingredients in peppermint essential oil are: menthol, menthone, menthyl acetate, cineole, limonene, pulegone, borneol and carvone.
Category
Treatment - Other

2

Description
Intervention group: On the first day of the intervention, the participant will be presented with a cotton ball dipped in two drops of rosemary oil and then asked to place it 5 cm away from the nose. This intervention will be done as the first aromatherapy session in the operating room in a private room shortly before the student's internship (7:30-7:45 in the morning). In addition, the essential oil used in this research is 100% pure. Peppermint essential oil is produced by Barij Essential Oil Company in Kashan. The compounds found in rosemary are as follows: α-pinene, 1-8-cineole, beta-pinene, borneol, p-cymene, d-limonene, camphor, camphene and α-terpineol.
Category
Treatment - Other

3

Description
Control group: On the first day of the intervention, a cotton ball dipped in two drops of placebo (distilled water) will be presented to the participant and then asked to place it at a distance of 5 cm from the nose. This intervention will be done as the first aromatherapy session in the operating room department in a private room shortly before the start of the student's internship (7:30-7:45 in the morning).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein (AS) Shahroud Hospital
Full name of responsible person
Mobin Mottahedi
Street address
Imam Hossein (AS) Shahrood Hospital, Imam St., at the end of 28 meters of Ayat A... Tawhidi, Shahrood
City
Shahroud
Province
Semnan
Postal code
3616951835
Phone
+98 23 3234 2000
Email
Mobinmottahedi1372@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hossein Bagheri
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3251 2173
Email
Mobinmottahedi1372@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3251 2173
Email
Mobinmottahedi1372@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahrood
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3251 2173
Email
Mobinmottahedi1372@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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