The Effect of Aromatherapy with the Scent of Moist Soil on Reducing Exam Anxiety and Enhancing Concentration in Pharmacy Students

To evaluate the effect of aromatherapy with petrichor aroma containing geosmin on exam anxiety and academic performance in pharmacy students

A double blinded randomized controlled clinical trial with parallel groups. Participants are allocated to intervention or control groups using block randomization based on a computer generated sequence and sealed opaque envelopes. The sample size is 64 patients in each groups.

The trial will be conducted at the School of Pharmacy of Mashhad University of Medical Sciences during the pharmacotherapy course examination. After eligibility screening and informed consent, participants are randomly assigned to the study groups. Aromatherapy or placebo is administered before the exam. Exam anxiety questionnaires are completed and exam scores are obtained from the education office. Participants and outcome assessors are blinded.

Participants are pharmacy students at Mashhad University of Medical Sciences; age 20 to 40 years; scheduled to take the pharmacotherapy course exam in the current semester. Non inclusion criteria include recent use of anxiolytics, acute respiratory illness, severe fragrance allergy, unstable medical conditions, or unwillingness to participate.

Participants in the intervention group receive an aromatherapy solution containing petrichor aroma with geosmin through inhalation shortly before the exam. The control group receives a placebo solution consisting of sterile distilled water without geosmin using the same procedure and duration. The containers and procedures are identical in both groups.

Change in exam anxiety severity based on a standardized anxiety questionnaire score before and immediately prior to the exam; pharmacotherapy course exam score as a measure of academic performance.

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.

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.

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.

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.

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.

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).

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.

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.

All data will be completely de-identified before sharing. We reserve the right to revoke or restrict access in the event of potential abuse.