Comparing the effect of virtual reality and aromatherapy with lavender on anxiety caused by bone marrow biopsy
Design
A randomized controlled clinical trial with no blinding, with parallel groups, conducted on 132 patients. Sealed envelope software was used for randomization.
Settings and conduct
Sampling will be available and the names of these people will be recorded based on the order of entry and entry and exit criteria. The present research will be without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, age between 18 and 60 years, having the power of sight and hearing and the ability to read and write in Persian language, absence of severe psychiatric disorders, not having a history of allergies to aromatic substances and proven problems in the sense of smell, no prior allergy to lavender.
Exclusion criteria: withdrawal and unwillingness to continue participation at any stage, the occurrence of any acute medical condition that contradicts the patient's participation
Intervention groups
In all three groups, a questionnaire related to demographic characteristics and Spielberger anxiety will be completed. People will be subjected to aromatherapy or virtual reality intervention for 12-20 minutes while waiting. Virtual reality will be through a virtual reality device and headset, and the aromatherapy group will also be asked to smell the aromatherapy through natural breathing for 12-20 minutes. People in the control group also spend the same waiting period without intervention and according to the usual conditions, until they are called according to their turn.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240711062391N1
Registration date:2024-08-17, 1403/05/27
Registration timing:prospective
Last update:2024-08-17, 1403/05/27
Update count:0
Registration date
2024-08-17, 1403/05/27
Registrant information
Name
Erfan Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 8149
Email address
erfanmohammadiuniversity@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of virtual reality and aromatherapy with lavender on anxiety caused by bone marrow biopsy
Public title
Comparing the effect of virtual reality and aromatherapy with lavender on anxiety caused by bone marrow biopsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
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).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij St, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3818887174
Approval date
2024-06-23, 1403/04/03
Ethics committee reference number
IR.ARAKMU.REC.1403.133
Health conditions studied
1
Description of health condition studied
Anxiety caused by bone marrow biopsy
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after the intervention
Method of measurement
The State-Trait Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
3
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Atefeh Saleh Fard
Street address
Daneshgah St
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5007
Email
info_khansari@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/khansarihos/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Street address
Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
research@arakmu.ac.ir
Web page address
https://research.arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?