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IRCT20240711062391N1 IRCT 2024-08-17 Arak University of Medical Sciences Comparing the effect of virtual reality and aromatherapy with lavender on anxiety caused by bone marrow biopsy Comparing the effect of virtual reality and aromatherapy with lavender on anxiety caused by bone marrow biopsy 2024-09-22 anticipated 132 Complete https://irct.ir/trial/78145 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, random blocks will be used in order to hide the randomized allocation (concealment) and establish balance (balance) during and after the study. In this way, based on the sample size, people will be randomly placed in blocks of 3. Random sequence generation will be done by block building method by Sealed envelope software. In the mentioned software, the total sample size and the number of groups are entered into the software. The randomization unit in the mentioned software is a person. The output of the software is a grouped list that randomly distributes the number of samples in three groups. According to the mentioned list, patients are distributed in three groups according to the time of visit so that the sample size reaches the required number in each group. The randomized list in the form of an Excel file will only be available to the researcher (M-H). 3 Anxiety caused by bone marrow biopsy. Intervention 1: first Intervention group: After randomization, a questionnaire related to demographic characteristics and Spielberger anxiety will be completed. Then people will be subjected to aromatherapy intervention during the waiting time and for 12-20 minutes. In the aromatherapy group, 2 drops of lavender essential oil (Provided by Ellis Pharmaceutical Company, Kazeroon, Iran) will be poured with a dropper on a 10 x 10 cm gas and will be connected to a distance of 20 cm from the subject's nose and on their shirt. They will be asked to inhale the aromatherapy through natural breathing for 12-20 minutes. Intervention 2: second Intervention group: Intervention group: After randomization, a questionnaire related to demographic characteristics and Spielberger anxiety will be completed. Then people will be subjected to virtual reality intervention during the waiting time and for 12-20 minutes. The equipment used for the virtual reality technique will be a virtual reality device (Remax-RT-V03 audio visual glasses with internal memory) and headset, with the help of which, patients are exposed to the sound and pleasant scenes of nature with high quality. In this way, conditions are provided for them to experience more relaxation by diverting their thoughts and immersing themselves in a pleasant and enjoyable environment instead of focusing on the surgical process. Intervention 3: Control group: After randomization, a questionnaire related to demographic characteristics and Spielberger's anxiety will be completed. People in the control group spend the same waiting period without intervention and under usual conditions until they are called according to their turn. 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 Its release schedule is not yet known
public Erfan Mohammadi
Shahamat 2 Alley, Shahamat St., Moshaver Town, Arak, IRAN
Arak Iran (Islamic Republic of) 3818887174 +98 86 3368 8149 erfanmohammadiuniversity@gmail.com Arak University of Medical Sciences scientific Moloud Farmahini Farahani
Blue wing, Nursing school, Basij Square, Arak, Markazi Province, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3383 8246 mfarmahini@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Age between 18 and 60 years Having the necessary eyesight and hearing Having the ability to read and write in Persian Not suffering from severe psychiatric disorders such as psychotic disorders, bipolar mood disorder, panic disorder and depression. Not having a history of allergy to aromatic substances, proven problems in the sense of smell, previous allergy to lavender and an allergy 18 years 60 years Both Withdrawal and unwillingness to continue participating in any stage of the study according to the patient's choice and decision Occurrence of any special medical condition that is contrary to the continued participation of individuals F06.4 Anxiety disorder due to known physiological condition Rehabilitation Rehabilitation N/A first Intervention group: After randomization, a questionnaire related to demographic characteristics and Spielberger anxiety will be completed. Then people will be subjected to aromatherapy intervention during the waiting time and for 12-20 minutes. In the aromatherapy group, 2 drops of lavender essential oil (Provided by Ellis Pharmaceutical Company, Kazeroon, Iran) will be poured with a dropper on a 10 x 10 cm gas and will be connected to a distance of 20 cm from the subject's nose and on their shirt. They will be asked to inhale the aromatherapy through natural breathing for 12-20 minutes. second Intervention group: Intervention group: After randomization, a questionnaire related to demographic characteristics and Spielberger anxiety will be completed. Then people will be subjected to virtual reality intervention during the waiting time and for 12-20 minutes. The equipment used for the virtual reality technique will be a virtual reality device (Remax-RT-V03 audio visual glasses with internal memory) and headset, with the help of which, patients are exposed to the sound and pleasant scenes of nature with high quality. In this way, conditions are provided for them to experience more relaxation by diverting their thoughts and immersing themselves in a pleasant and enjoyable environment instead of focusing on the surgical process. Control group: After randomization, a questionnaire related to demographic characteristics and Spielberger's anxiety will be completed. People in the control group spend the same waiting period without intervention and under usual conditions until they are called according to their turn. Anxiety. Timepoint: Before and after the intervention. Method of measurement: The State-Trait Anxiety Inventory. Arak University of Medical Sciences Approved 2024-06-23 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij St, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)