The effect of aromatherapy with lavender essential oil on pain intensity and sleep quality in patients with sickle cell disease

Determining the effect of lavender aromatherapy on pain intensity and sleep quality in patients with sickle cell disease

This randomized, single-blind, parallel-group clinical trial includes 56 patients, with randomization conducted via permuted blocks of four using www.sealedenvelope.com

This two-group randomized clinical trial at Baghaei 2 Hospital, Ahvaz, will randomly assign participants to an intervention (lavender essential oil) or control (placebo) group. Both assessor and researcher will be blinded, and pain intensity and sleep quality will be measured using standardized self-report instruments pre- and post-intervention.

Inclusion Criteria: Definitive diagnosis of sickle cell disease Age between 18 and 65 years Willingness to participate in the study and provision of written informed consent Ability to read and write in Persian Intact olfactory function A score of 5 or higher on the Pittsburgh Sleep Quality Index A score of 3 or higher on the Numeric Rating Scale for pain intensity Exclusion Criteria: Presence of severe psychiatric disorders Pregnancy Use of complementary medicine therapies Current or past (within the previous 12 months) diagnosis of stimulant, cannabinoid, or hallucinogen use disorder, alcohol use disorder, or high-risk alcohol consumption Diagnosis of opioid use disorder Presence of acute illnesses or unstable medical conditions Presence of chronic respiratory diseases

Participants in the intervention group applied three drops of 100% pure lavender essential oil onto a 2 × 2 cm cotton pad each night at 10:00 PM for two weeks, attaching it to their clothing collar at 20 cm and removing it at 8:00 AM. The control group received aromatherapy in the same manner using a placebo (sweet almond oil).

Pain intensity and sleep quality

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.

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.

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.

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.

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.

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.

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.

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.