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IRCT20241125063850N1 IRCT 2025-04-18 Khomein Faculty of Medical Sciences The Effect of Lavender Aromatherapy and Virtual Reality on the Sleep Quality of Patients with Type 2 Diabetes Virtual Reality (VR) Comparing the Effects of Lavender Aromatherapy with Virtual Reality on the Quality of Sleep in Type 2 Diabetic Patients 2025-04-21 anticipated 90 Complete https://irct.ir/trial/82115 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 1. Method of Randomization: - Simple randomization using a random number table will be employed. 2. Unit of Randomization: - Individual-based randomization will be applied, meaning each diabetic patient will be independently assigned to a group. 3. Randomization Tools: - A random number table will be used to generate the sequence. - Sealed, opaque envelopes will be prepared to conceal group assignments, ensuring they remain undisclosed until the intervention begins. 4. Procedure for Generating Random Sequence: - The sequence will be generated using statistical software such as SPSS, ensuring both randomness and reproducibility. - The generated sequence will be securely stored and used exclusively by an independent team member responsible for allocation. 5. Allocation Concealment: - Allocation concealment will be achieved through sealed, opaque envelopes prepared in advance. These envelopes will be carefully shuffled and sequentially numbered. Each participant will select an envelope upon enrollment, and their group assignment will be determined accordingly, eliminating bias. - The individual responsible for recruiting and enrolling participants will have no involvement in the allocation process, ensuring no potential bias occurs, Blinding description: In the present study, only the statistician, who will be responsible for data analysis and final conclusions, will be blinded. This means they will be unaware of the group assignment related to the questionnaire data and will not know whether the data belong to the aromatherapy group, the VR group, or the control group. N/A Type 2 Diabetes. Intervention 1: The aromatherapy intervention group with lavender essential oil: In this group, each patient will apply 2 drops of lavender essential oil (in this study, the essential oil is obtained from the Gia Kala company, which holds production licenses from the Food and Drug Administration, Ministry of Industry, and certifications including ISO 14001, 22000, and HACCP. The lavender essential oil is produced using completely standard and organic raw materials. The analysis method is HPLC, the production process is 100% hygienic and antimicrobial, and the extraction is carried out with scientific and knowledge-based methods using an ethanol-water solvent) onto a piece of cotton every night before sleep. The cotton is then placed in front of the patient's nose, where they will perform 10 deep breaths. The cotton will be pinned to the patient's shirt and will remain attached until 8 a.m. the following morning. This intervention will be carried out for three consecutive nights. Intervention 2: Intervention group VR: In the VR group, a video featuring high-quality calming images of nature will be played for the patient for 15 minutes before sleep. Intervention 3: Control group: In the control group, no intervention will be performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no additional information.
public Melika Jafari Dehnayebi
Quds Avenue
khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 melika.jafry@gmail.com Khomein Faculty of Medical Sciences scientific Mahdi Safar Abadi
Quds Avenue
khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mahdisafarabadi@gmail.com Khomein Faculty of Medical Sciences Iran (Islamic Republic of) Age 18 years or older Informed consent and willingness to participate in the research A confirmed diagnosis of type 2 diabetes by an endocrinologist Having a score of 5 or higher on the Pittsburgh Sleep Quality Index (PSQI) 18 years no limit Both Sensitivity to the scent of lavender Having conditions such as asthma, migraines, and headaches Impairments in the sense of smell or vision, or having respiratory diseases Use of complementary medicine in the past month E11.6 Type 2 diabetes mellitus with other specified complications Rehabilitation Rehabilitation N/A The aromatherapy intervention group with lavender essential oil: In this group, each patient will apply 2 drops of lavender essential oil (in this study, the essential oil is obtained from the Gia Kala company, which holds production licenses from the Food and Drug Administration, Ministry of Industry, and certifications including ISO 14001, 22000, and HACCP. The lavender essential oil is produced using completely standard and organic raw materials. The analysis method is HPLC, the production process is 100% hygienic and antimicrobial, and the extraction is carried out with scientific and knowledge-based methods using an ethanol-water solvent) onto a piece of cotton every night before sleep. The cotton is then placed in front of the patient's nose, where they will perform 10 deep breaths. The cotton will be pinned to the patient's shirt and will remain attached until 8 a.m. the following morning. This intervention will be carried out for three consecutive nights. Intervention group VR: In the VR group, a video featuring high-quality calming images of nature will be played for the patient for 15 minutes before sleep. Control group: In the control group, no intervention will be performed. The sleep quality score in the Pittsburgh Sleep Quality Index (PSQI). Timepoint: Measurement of sleep quality using a questionnaire at the beginning of the intervention (before the start of the intervention) and three days after the initiation of lavender aromatherapy or VR intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Khomein Faculty of Medical Sciences Approved 2025-03-04 Ethics Committee of Khomein University of Medical Sciences Quds Avenue khomein Markazi Iran (Islamic Republic of)