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IRCT20260120068622N1 IRCT 2026-02-27 Ahvaz University of Medical Sciences The effect of lavender on pain intensity and sleep quality in patients with sickle cell disease The effect of aromatherapy with lavender essential oil on pain intensity and sleep quality in patients with sickle cell disease 2026-03-09 anticipated 56 Complete https://irct.ir/trial/89039 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be conducted using a convenience sampling method. To allocate participants to the two groups, namely the “intervention” and “control” groups, a four-part block randomization method will be used. In this method, all eligible participants will first enter the allocation process. Then, by forming blocks consisting of four participants, group allocation will be performed randomly while maintaining an equal allocation ratio. In each four-part block, two participants will be assigned to the intervention group and two participants to the control group. The website www.sealedenvelope.com will be used to generate random blocks for assigning participants to the groups. Considering that this study includes two groups, the four-part blocks may be arranged as follows: • C C M M • C M C M • M C M C • M M C C • C M M C • M C C M In these combinations, C denotes the control group and M denotes the intervention group. Subsequently, these six blocks will be numbered and randomly selected from among them (for example, using a random number table or software). Then, these blocks will be placed sequentially to form the randomization sequence, and allocation to the control and intervention groups will be performed using block randomization without blinding, Blinding description: Because of the nature of aromatherapy, blinding of participants is not feasible; therefore, in the present study, blinding will be applied at the level of the researcher and the outcome assessor. In this regard, both the researcher and the assessor will be unaware of the type of aroma received by the participants. N/A sickle cell disease. Intervention 1: Intervention group: Participants in the intervention group will be instructed to, for two weeks, place three drops of 100% pure lavender essential oil, prepared by Barij Essence Kashan Pharmaceutical Company, onto a 2 × 2 cm cotton pad each night at 22:00 before bedtime. The cotton pad will then be attached to the collar of their clothing at a distance of 20 cm from the neck and removed in the morning at 08:00 upon waking. The placement and attachment procedure of the cotton pad to the collar will be demonstrated to the participants practically by the researcher. Intervention 2: Control group: Participants in the control group will be instructed to, for two weeks, place three drops of 100% pure sweet almond oil, prepared by Barij Essence Kashan Pharmaceutical Company, onto a 2 × 2 cm cotton pad each night at 22:00 before bedtime, attach it to the collar of their clothing at a distance of 20 cm from the neck, and remove it in the morning at 08:00 upon waking. The placement and attachment procedure of the cotton pad to the collar will be demonstrated to the participants practically by the researcher. Yes - There is a plan to make this available What will be shared: Dataset title: Data dictionary for the study on the effect of aromatherapy with lavender essential oil on pain intensity and sleep quality in patients with sickle cell disease Sharing plan details: The data dictionary includes: • Definitions of all demographic variables of participants • Definitions of variables related to primary and secondary outcomes (pain intensity, sleep quality) • Data coding methods and measurement units • Permissible values and range for each variable • Description of data standardization and coding procedures This data dictionary enables researchers to accurately analyze and interpret the study data while ensuring that no identifiable participant information is included. When: The study-related data and documents (including de-identified individual participant data, the data dictionary, statistical analysis plan, final protocol, informed consent form, and clinical study reports) will be available to qualified researchers from the time of publication of the primary study results.The data and documents will remain accessible for up to five years after the publication of the primary results, which is a standard period allowing for secondary analyses and further scientific use. To whom: The study data and documents will be available only to qualified researchers. Qualified researchers are defined as individuals with a verified academic or scientific background in the relevant field and who can provide a clearly defined research proposal with specific scientific objectives. Eligible recipients may be affiliated with universities, research centers, or other recognized scientific institutions. Industry-based researchers may also request access, provided that the intended use is for scientific purposes and ethical considerations are fully addressed. Conditions: The provided data and documents may only be used for scientific and research purposes directly related to the study topic. Researchers requesting access must submit a detailed research proposal clearly outlining the objectives, methods, and types of analyses planned on the data. Permitted analyses include: • Examination of primary and secondary study outcomes • Secondary statistical analyses with valid scientific objectives • Meta-analyses or systematic reviews based on the provided data Use of the data for commercial or promotional purposes is not permitted. All researchers must adhere to research ethics, confidentiality, and participant anonymization. Accompanying documents may be used solely to support scientific analyses and interpretation of the data and must not be reproduced or redistributed without permission. Where to obtain: The study data and documents will be available through direct communication with the corresponding author. Interested researchers must submit a formal request via official institutional email to the corresponding author. Upon review and approval by the research team, the requested data and documents will be provided in encrypted format through secure data transfer methods. The data will not be deposited in a public repository, and access will be granted exclusively through formal communication with the research team. How to obtain: Researchers seeking access to the study data and documents must follow these steps: 1. Submit a formal request: The researcher must send a formal request via official institutional email to the corresponding author. The request should include a detailed research proposal specifying objectives, methods, and planned analyses. 2. Scientific and ethical review: The research team will review the request for scientific validity and ethical compliance. This step typically takes 2 to 4 weeks, depending on the complexity of the request and the number of requests received. 3. Approval and preparation of data and documents: Upon approval, the requested data and documents will be prepared in a secure, de-identified format. This preparation usually takes 1 to 2 weeks. 4. Delivery to the requester: The data and documents will be delivered to the approved researcher through secure data transfer methods. Comments:
public Zahra Abdollahi
Faculty of Nursing and Midwifery, North Esfand Street, Ahvaz Jondishapur University of Medical Sciences, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8538 abdollahi.za@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mehrnaz Ahmadi
Faculty of Nursing and Midwifery, North Esfand Street, Ahvaz Jondishapur University of Medical Sciences, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8538 ahmadi-me@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of sickle cell disease based on valid medical documentation and standard laboratory tests (such as hemoglobin electrophoresis) Age between 18 and 65 years Willingness to participate in the study and to provide informed consent Ability to read and write in Persian (for completing the questionnaires) Intact olfactory function based on self-report and a simple olfactory test A score of 5 or higher on the Pittsburgh Sleep Quality Index (PSQI) A score of 3 or higher on the Numeric Rating Scale (NRS) for pain intensity 18 years 65 years Both Presence of severe psychiatric disorders (based on medical records). Pregnancy. Use of complementary medicine approaches (such as yoga and massage). Presence of stimulant substance use disorders (e.g., amphetamines), cannabinoid use disorders, hallucinogen use, or alcohol use or high-risk alcohol consumption within the past 12 months (based on medical records or self-report). Presence of opioid use disorder (according to clinical criteria or evidence of misuse as determined by the treating physician). Presence of acute illnesses or unstable medical conditions that would preclude safe participation in the study (based on medical records or self-report). Presence of confirmed chronic respiratory diseases such as asthma and chronic obstructive pulmonary disease. D57 Sickle-cell disorders Other Placebo Intervention group: Participants in the intervention group will be instructed to, for two weeks, place three drops of 100% pure lavender essential oil, prepared by Barij Essence Kashan Pharmaceutical Company, onto a 2 × 2 cm cotton pad each night at 22:00 before bedtime. The cotton pad will then be attached to the collar of their clothing at a distance of 20 cm from the neck and removed in the morning at 08:00 upon waking. The placement and attachment procedure of the cotton pad to the collar will be demonstrated to the participants practically by the researcher. Control group: Participants in the control group will be instructed to, for two weeks, place three drops of 100% pure sweet almond oil, prepared by Barij Essence Kashan Pharmaceutical Company, onto a 2 × 2 cm cotton pad each night at 22:00 before bedtime, attach it to the collar of their clothing at a distance of 20 cm from the neck, and remove it in the morning at 08:00 upon waking. The placement and attachment procedure of the cotton pad to the collar will be demonstrated to the participants practically by the researcher. Pain intensity score measured by the Brief Pain Inventory. Timepoint: Measurement of pain intensity at the beginning of the study (before the intervention) and 14 days after the start of lavender essential oil administration (after the end of the intervention). Method of measurement: Brief Pain Inventory. Pain intensity score on the Numeric Rating Scale. Timepoint: Measurement of pain intensity at the beginning of the study (before the intervention) and on days 7 and 14 after the start of lavender essential oil administration. Method of measurement: Numeric Rating Scale for pain intensity. Sleep quality score on the Pittsburgh Sleep Quality Index. Timepoint: Measurement of sleep quality at the beginning of the study (before the intervention) and 14 days after the start of lavender essential oil administration (after the end of the intervention). Method of measurement: Pittsburgh Sleep Quality Index. Ahvaz University of Medical Sciences Approved 2025-12-28 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University of Medical Sciences, Esfand Shomali St., Golestan Alley, Ahvaz, Khuzestan Ahvaz Khouzestan Iran (Islamic Republic of)