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IRCT20260224068930N1 IRCT 2026-04-29 Jahrom University of Medical Sciences Comparison of the Effects of Lavender and Rose Aromas on Vaccination Pain Comparison of the Effects of Lavender and Rose Aromas on Vaccination Pain in 2-Month-Old Infants: A Randomized Triple-Blind Clinical Trial 2026-05-22 anticipated 75 Complete https://irct.ir/trial/89424 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Target Population: All healthy two-month-old children who visit selected vaccination centers in Jahrom for their periodic vaccinations. Sampling Framework: The list of visitors to the vaccination center during the sampling period (designated shifts) will be considered as the framework, and samples will be selected from eligible visitors according to the established method. To maintain a balance in the number of individuals in each group, a block randomization method with block sizes of six will be used. In this method, for each block of six individuals, the sequence of group assignments will be determined randomly, ensuring that in each block, two children are assigned to the inhalation group of lavender essential oil, two to the inhalation group of rose essential oil, and two to the control group (distilled water). The random sequence for group assignment for each block will be generated by an independent researcher who does not play a role in the recruitment process, intervention implementation, or data collection, using Excel software. Then, each participant's assignment will be placed separately in opaque, sealed, and consecutively numbered envelopes (the block assignments are presented in the table below the text). Upon each participant's entry into the study, after confirming the inclusion criteria and obtaining informed consent from the parents, the researcher responsible for recording and enrolling participants will sequentially open the envelopes according to their numbers, and each child will be placed into one of the three study groups based on the group indicated on the envelope. Since the individual preparing the envelopes is different from the one opening them, and the outcome assessor is unaware of the group assignments, allocation concealment and blinding are maintained, thus reducing the likelihood of bias in the allocation process and the evaluation of results, Blinding description: This study will be conducted as a triple-blind trial. Given that the participants are two-month-old infants, blinding at the participant level is inherently established. Furthermore, the outcome assessor (pain intensity) and data analyst will remain unaware of the group assignments. The allocation process will also be conducted in a blinded manner using opaque and sealed envelopes. N/A Pain sensation during vaccination.. Intervention 1: Intervention group 1: Inhalation with lavender aroma involves diluting one drop of 100% pure lavender essential oil with four drops of distilled water, which is then placed on a piece of sterile cotton. The standard medicinal lavender essential oil is produced by Barij Essence Pharmaceutical Company, Mashhad Ardehal, Kashan, Iran. The cotton is positioned approximately two centimeters from the baby's nose, and inhalation continues from 5 minutes before to 2 minutes after vaccination, being performed once for each child. Intervention 2: Intervention group 2: Inhalation with the aroma of Rosa damascena involves moistening a piece of sterile cotton with two drops of 10% essential oil. The standard essential oil of rose is produced by Barij Essence Pharmaceutical Company, Mashhad Ardehal, Kashan, Iran. The cotton is positioned approximately two centimeters from the baby's nose, and inhalation continues from 5 minutes before to 2 minutes after vaccination, being performed once for each child. Intervention 3: Control group: In the control group, a piece of cotton soaked in distilled water is placed approximately two centimeters from the baby's nose, and inhalation continues from 5 minutes before to 2 minutes after vaccination, being performed once for each child. Yes - There is a plan to make this available What will be shared: Demographic information of the participants and pain scores based on the questionnaire will be released after anonymization. However, videos will only be shared if necessary and with the informed consent of the parents. When: Access period begins 6 months after the publication of the results To whom: Data is typically made available to researchers, universities, and organizations related to the research field. This includes students, researchers, and other interested parties. Additionally, many scientific journals request raw data for publication to verify the transparency and accuracy of the results. Conditions: 1. Clear Purpose: Applicants must state a clear purpose for using the data or documents. This purpose should align with research, educational, or social objectives. 2. Permitted Analyses: Analyses permitted on the data include statistical analyses, data modeling, and other non-destructive research methods. Any analysis must be conducted in a way that preserves the privacy and anonymity of individuals. 3. Permitted Uses of Documents: The use of documents is allowed for generating scientific and research results, presenting papers, or educational projects. Any commercial or non-scientific use is prohibited. 4. Legal Frameworks: Applicants must comply with legal and ethical requirements regarding privacy protection and data security. This includes signing confidentiality agreements and not disclosing information to third parties. 5. Requirements for Submitting Requests: -Provide identification information including name, title, and affiliated organization. -Clearly state the type of data or documents needed for access. -Provide a scientific justification for the need for access to the data or documents. -Confirm that the applicant agrees to the terms of use for the data and documents. Where to obtain: Applicants should follow the methods below to request data/documents: Email: F.Nazari@jums.ac.ir; Liliom75.af@gmail.com Contact Numbers: 00989172233032; 00989368412261 Postal Address: Iran - Fars - Jahrom - Jahrom University of Medical Sciences - Nursing School - First Floor Fatemeh Nazari - Faculty Member Office Phone: 00987154340405-10; Extension 385 How to obtain: 1. Submitting the Request: The applicant must first submit their request via email or the contact numbers provided in the notice. At this stage, it is essential for the applicant to provide their complete details, the type of documents or data files required, and the purpose of the request. 2. Reviewing the Request: After receiving the request, the relevant team will review it. This stage may take up to 3 business days. If additional information is needed, the applicant may be contacted. 3. Approval and Preparation: If the request is approved, the process of gathering and preparing the documents or data files will begin. The duration of this stage may take between 5 to 10 business days, depending on the type and volume of the request. 4. Sending the Documents: Once prepared, the documents or data files will be sent to the applicant via email, or if a postal delivery is requested, they will be sent to the specified address. Postal delivery may take longer, usually between 5 to 15 business days. In total, the applicant can expect the entire process from submitting the request to receiving the documents to take about 2 to 4 weeks. If any delays occur during this period, the applicant can follow up by contacting the provided numbers. Comments:
public Fatemeh Nazari
Motahhari Street - Pardis Site - Jahrom University of Medical Sciences - Faculty of Nursing - Jahrom
Jahrom Iran (Islamic Republic of) 7414846199 +98 71 5447 5601 F.Nazari@jums.ac.ir Jahrom University of Medical Sciences scientific Fatemeh Nazari
Motahhari Street - Pardis Site - ahrom University of Medical Sciences - Faculty of Nursing - Jahrom
Jahrom Iran (Islamic Republic of) 7414846199 +98 71 5447 5601 F.Nazari@jums.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Children aged 2 months to 2 months and 29 days. Only healthy children (without any illness or symptoms such as fever, runny nose, diarrhea, etc.) Children with suitable weight and general condition for vaccination. Parents/legal guardians must sign an informed consent form. Children who do not have systemic diseases (such as diabetes, vascular diseases, congenital anomalies, etc.). Children with no history of hospitalization for any reason (as hospitalization has long been recognized as a painful experience that may affect children's outcomes). No known allergies to essential oils or herbal oils. No bleeding disorders or hematological conditions (as these disorders may cause bleeding post-injection and complicate the situation, interfering with the assessment of the desired outcome). 2 months 89 days Both Occurrence of any unusual and observable adverse events related to the vaccine injection, including active bleeding, trauma, bruising, or hematoma, which should be recorded in the "Intervention Cessation or Possible Adverse Effects" section of the researcher's data collection form. Children for whom vaccination may be difficult due to any skin or subcutaneous tissue problems (such as old hematomas, skin infections, etc.). Any use of analgesic/sedative medications within 24 hours prior to vaccination. Occurrence of an allergic reaction or severe restlessness prior to the intervention. Other Other Placebo Intervention group 1: Inhalation with lavender aroma involves diluting one drop of 100% pure lavender essential oil with four drops of distilled water, which is then placed on a piece of sterile cotton. The standard medicinal lavender essential oil is produced by Barij Essence Pharmaceutical Company, Mashhad Ardehal, Kashan, Iran. The cotton is positioned approximately two centimeters from the baby's nose, and inhalation continues from 5 minutes before to 2 minutes after vaccination, being performed once for each child. Intervention group 2: Inhalation with the aroma of Rosa damascena involves moistening a piece of sterile cotton with two drops of 10% essential oil. The standard essential oil of rose is produced by Barij Essence Pharmaceutical Company, Mashhad Ardehal, Kashan, Iran. The cotton is positioned approximately two centimeters from the baby's nose, and inhalation continues from 5 minutes before to 2 minutes after vaccination, being performed once for each child. Control group: In the control group, a piece of cotton soaked in distilled water is placed approximately two centimeters from the baby's nose, and inhalation continues from 5 minutes before to 2 minutes after vaccination, being performed once for each child. Pain score measurement based on the NIPS questionnaire. Timepoint: 1 minute before the intervention, during the intervention, 2 minutes after the intervention. Method of measurement: NIPS questionnaire. Jahrom University of Medical Sciences Approved 2026-02-17 Research Ethics committee of Jahrom University of Medical Sciences Jahrom, at the end of Shahid Beheshti Boulevard, Office of the President and Vice Chancellor for Development of Jahrom University of Medical Sciences. Jahrom Fars Iran (Islamic Republic of)