Comparing the Effects of Lavender Aromatherapy with Virtual Reality on the Quality of Sleep in Type 2 Diabetic Patients

The Comparison of the Effects of Lavender Aromatherapy and Virtual Reality on the Sleep Quality of Patients with Type 2 Diabetes.

A clinical trial with a control group, two parallel intervention groups, and a single-blind design.90 patients were randomized using a random number table.

In this single-blind clinical trial, 90 type 2 diabetic patients at Hazrat Zahra (S) Hospital in Khomein were randomly assigned to control, aromatherapy, and VR groups. The statistician responsible for data analysis will be blinded. Aromatherapy Group: Patients apply 2 drops of lavender essential oil on a cotton ball before bedtime and take 10 deep breaths. VR Group: Soothing nature videos play for 15 minutes before sleep. Control Group: No intervention is performed.Patients complete the Pittsburgh Sleep Quality Index (PSQI) questionnaire before and after the intervention.

Inclusion Criteria: Age 18+, informed consent, willingness to participate, diagnosed with type 2 diabetes by an endocrinologist, and a PSQI score of 5+. Exclusion Criteria: Sensitivity to lavender, asthma, migraines, headaches, using sleeping pills/antidepressants, olfactory/visual impairments, respiratory diseases, and using complementary medicine in the past month.

Aromatherapy Group: Each night, 2 drops of lavender essential oil are placed on a cotton ball before sleep. Patients take 10 deep breaths, and the cotton ball is attached to their shirt until morning. This is repeated for three consecutive nights. Virtual Reality (VR) Group: High-quality soothing nature videos are played for 15 minutes before sleep. Control Group:No intervention is performed.

The sleep quality score in the Pittsburgh Sleep Quality Index (PSQI).

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.

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.