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IRCT20251208068253N2 IRCT 2026-05-15 Mashhad University of Medical Sciences The Effect of Aromatherapy with the Scent of Moist Soil on Anxiety and Concentration The Effect of Aromatherapy with the Scent of Moist Soil on Reducing Exam Anxiety and Enhancing Concentration in Pharmacy Students 2026-06-22 anticipated 142 Recruiting https://irct.ir/trial/89855 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is designed as a double blind randomized controlled trial. Participants will be randomly allocated to the intervention group receiving the petrichor aroma or the control group receiving the placebo solution. The aromatic solutions will be prepared and coded by an independent researcher who is not involved in participant recruitment, outcome assessment, or data analysis. Both solutions will be placed in identical containers with similar appearance. Participants, investigators involved in data collection, and outcome assessors will remain unaware of the group allocation throughout the study. The allocation code will be kept confidential and will only be revealed after completion of data collection and primary data analysis, Blinding description: This study is designed as a double blind randomized controlled trial. Participants will be randomly allocated to the intervention group receiving the petrichor aroma or the control group receiving the placebo solution. The aromatic solutions will be prepared and coded by an independent researcher who is not involved in participant recruitment, outcome assessment, or data analysis. Both solutions will be placed in identical containers with similar appearance. Participants, investigators involved in data collection, and outcome assessors will remain unaware of the group allocation throughout the study. The allocation code will be kept confidential and will only be revealed after completion of data collection and primary data analysis. 3 Condition 1: Generalized anxiety disorder. Condition 2: Adjustment disorders. Intervention 1: Intervention group: Participants in the intervention group are exposed to aromatherapy with the smell of moist soil before the examination. For this purpose a specified amount of moist soil scent extract is placed on a sterile absorbent pad positioned approximately 30 centimeters from the participant allowing the aroma to be inhaled naturally. The intervention is performed in a quiet and controlled environment for 10 minutes prior to the beginning of the examination. Participants remain seated and breathe normally during the exposure period. Intervention 2: Control group: Participants in the control group are exposed to a neutral smelling solution that is used as a placebo before the examination. For this purpose a specified amount of an inactive odorless solution is placed on a sterile absorbent pad positioned approximately 30 centimeters from the participant. The intervention is performed in a quiet and controlled environment for 10 minutes prior to the beginning of the examination. Participants remain seated and breathe normally during the exposure period. The environmental conditions, duration of exposure and procedure are identical to the intervention group and the only difference is the absence of the moist soil smell in the solution used for the control group. Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Data (IPD) that will be available for sharing with other researchers upon reasonable request after the study's completion and publication of the main results. This includes demographic information, complete responses to the questionnaires and other secondary outcomes. The final study protocol (approved by the ethics committee), Statistical Analysis Plan (SAP), informed consent form, final Clinical Study Report (CSR), SPSS analysis code, and data dictionary will also be shared. When: Access to data and documents will begin 12 months after the publication of the primary study results in a peer-reviewed journal and will be available for 5 years. To whom: Researchers and scientists affiliated with recognized academic, research, or healthcare institutions who have a valid research question and a specified analysis plan. Requests for purposes such as meta-analysis, validation of results, or other research projects will be considered. Conditions: The data and documents can only be used for non-commercial, scientific research purposes. The requester must provide a brief research proposal (max 2 pages) outlining the scientific objectives, proposed analysis methodology, and a commitment to ethical use and source attribution. Data use must comply with ethical and privacy regulations, and results derived must be published in scientific formats (articles, conferences). Where to obtain: Requesters can send their application along with a brief proposal in Persian or English to the official email address of the Principal Investigator at [Abeditf@mums.ac.ir]. The requester's name and institutional affiliation must be clearly stated. How to obtain: Upon receiving a request, the Principal Investigator and the study steering committee will review the proposal for its scientific and ethical merit. An initial response will be provided within 4 weeks. If preliminarily approved, a Data Transfer Agreement (DTA) outlining the terms of use will be executed. Following the signed DTA, the requested data/documents will be provided via a secure platform (e.g., encrypted cloud drive) within 2 weeks. The entire process may take 6 to 8 weeks. Comments: All data will be completely de-identified before sharing. We reserve the right to revoke or restrict access in the event of potential abuse.
public Farshad Abedi
Faculty of Pharmacy, East Gate of University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1589 Abeditf@mums.ac.ir Mashhad University of Medical Sciences scientific Farshad Abedi
Faculty of Pharmacy, East Gate of University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1589 Abeditf@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Pharmacy students currently enrolled at the School of Pharmacy of Mashhad University of Medical Sciences Age between 20 and 40 years Participation in the specified pharmacotherapy course examination during the current semester Willingness to participate in the study and signing the written informed consent 20 years 40 years Both History of major psychiatric disorders Use of anxiolytics or other medications affecting mood or stress during the past four weeks History of severe allergy or hypersensitivity to fragrances or perfumes Presence of serious respiratory diseases that limit inhalation of fragrances Presence of acute illness or unstable medical condition at screening F41.1 F43.2 Generalized anxiety disorder Adjustment disorders Treatment - Drugs Treatment - Drugs Intervention group: Participants in the intervention group are exposed to aromatherapy with the smell of moist soil before the examination. For this purpose a specified amount of moist soil scent extract is placed on a sterile absorbent pad positioned approximately 30 centimeters from the participant allowing the aroma to be inhaled naturally. The intervention is performed in a quiet and controlled environment for 10 minutes prior to the beginning of the examination. Participants remain seated and breathe normally during the exposure period. Control group: Participants in the control group are exposed to a neutral smelling solution that is used as a placebo before the examination. For this purpose a specified amount of an inactive odorless solution is placed on a sterile absorbent pad positioned approximately 30 centimeters from the participant. The intervention is performed in a quiet and controlled environment for 10 minutes prior to the beginning of the examination. Participants remain seated and breathe normally during the exposure period. The environmental conditions, duration of exposure and procedure are identical to the intervention group and the only difference is the absence of the moist soil smell in the solution used for the control group. Exam anxiety score according to the Depression, Anxiety and Stress Scale consisting of 21 items (DASS-21) questionnaire. Timepoint: Measured at two time points including before the intervention and immediately after the exam. Method of measurement: Depression, Anxiety and Stress Scale consisting of 21 items with calculation of the anxiety subscale score. Exam anxiety intensity measured using the Visual Analogue Scale for anxiety severity (VAS). Timepoint: Measured at two time points including before the intervention and immediately after the exam. Method of measurement: Visual Analogue Scale consisting of a 10 centimeter line on which the participant marks the perceived anxiety level ranging from zero meaning no anxiety to ten meaning the worst imaginable anxiety. Students academic performance score in the written course examination. Timepoint: The examination score at the end of the test. Method of measurement: Recording the written examination score of students according to the official university grading system. Students heart rate as a physiological indicator of stress. Timepoint: Measured at two time points including before the intervention and immediately after the examination. Method of measurement: Digital heart rate monitoring device. Students systolic and diastolic blood pressure as a physiological indicator of stress. Timepoint: Measured at two time points including before the intervention and immediately after the examination. Method of measurement: Digital blood pressure monitoring device. Mashhad University of Medical Sciences Approved 2026-04-11 Ethics Committee of Mashhad University of Medical Sciences Faculty of Medicine, East Gate of University Campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)