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The Effect of Lavender Aromatherapy on Aggression and Quality of Life in Patients with Schizophrenia

Protocol summary

Study aim
Investigating the effect of lavender aromatherapy on aggression and quality of life in patients with schizophrenia
Design
A Randomized Crossover Clinical Trial
Settings and conduct
The present study will be performed in the Ghaem Psychiatric Center in Shahroud county. In the intervention group, a lavender essential oil with a concentration of 1.5% for participants every night for 30 nights, before going to bed, three Pour a drop of essential oil on a piece of cotton and place it under the outer cover of the pillow. For the control group, sunflower oil will be used instead of lavender in the same way. The data collector, intervener and statistical analyst will not be aware of the contents of the containers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Be at least 15 years old, History of at least one month of hospitalization, Definitive diagnosis of schizophrenia by a psychiatrist, No cognitive impairment Exclusion criteria: Occurrence of stressful events one month before the study Drug addiction, Having an acute psychiatric condition that disrupts communication, Escape, death or transfer of the patient to other centers, Allergies to plants and their extracts, Perceptual disorders related to the sense of smell
Intervention groups
In the intervention group, lavender essential oil (from Stoechas species prepared by distillation method with a concentration of 1.5%, prepared by Barijessence Pharmaceutical co. Kashan) for participants every night for 30 nights, before going to bed, three Pour a drop of essential oil on a piece of cotton and place it under the outer cover of the pillow. For the control group, sunflower oil will be used instead of lavender in the same way.
Main outcome variables
Aggression and Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180728040617N5
Registration date: 2023-03-27, 1402/01/07
Registration timing: prospective

Last update: 2023-03-27, 1402/01/07
Update count: 0
Registration date
2023-03-27, 1402/01/07
Registrant information
Name
Seyedmohammad Mirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 3811
Email address
mirhoseinim@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Lavender Aromatherapy on Aggression and Quality of Life in Patients with Schizophrenia
Public title
The Effect of Lavender Aromatherapy on Aggression and Quality of Life in Patients with Schizophrenia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
History of at least one month of hospitalization Definitive diagnosis of schizophrenia by a psychiatrist No cognitive impairment Be at least 15 years old
Exclusion criteria:
Occurrence of stressful events one month before the study Drug addiction Having an acute psychiatric condition that disrupts communication Escape, death or transfer of the patient to other centers Allergies to plants and their extracts Perceptual disorders related to the sense of smell
Age
From 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 22. According to the sample size of 74 in the present study, 19 quadruple blocks will be considered. Each patient will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.SEMUMS.REC.1401.299

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Aggression
Timepoint
At the beginning of the study (before the intervention), one day and one week after the intervention
Method of measurement
Buss & Perry aggression questionnaire

2

Description
Quality of life
Timepoint
At the beginning of the study (before the intervention), one day and one week after the intervention
Method of measurement
Schizophrenia Quality of Life Scale (SQLS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The lavender essential oil (from Stoechas species prepared by distillation method with a concentration of 1.5%, prepared by Barijessence Pharmaceutical co. Kashan) for participants every night for 30 nights, before going to bed, three Pour a drop of essential oil on a piece of cotton and place it under the outer cover of the pillow.
Category
Rehabilitation

2

Description
Control group: Sunflower oil for participants will be poured three drops of it on a piece of cotton every night for 30 nights before going to bed and put a pillow under the outer cover.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Rehabilitation Center for Chronic Psychiatric Patients
Full name of responsible person
Seyedmohammad Mirhosseini
Street address
Shahid motahari St.
City
Shahroud
Province
Semnan
Postal code
3617645133
Phone
+98 23 3233 6043
Email
smohammadmh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Mir Mohammadkhani
Street address
Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmir@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Seyedmohammad Mirhosseini
Position
Instructor of Psychiatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th Tir Sq, Shahroud University of Medical Sciences, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 3811
Email
mirhoseinim@shmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Seyedmohammad Mirhosseini
Position
Instructor of Psychiatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th Tir Sq, Shahroud University of Medical Sciences, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 3811
Email
mirhoseinim@shmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Seyedmohammad Mirhosseini
Position
Instructor of Psychiatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th tir Sq, Shahroud University of Medical Sciences, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 3811
Fax
Email
mirhoseinim@shmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the patients' demographic information can be shared after unidentifying individuals. All quality of life and aggression assessment information can be shared with unidentified individuals.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Project partners
Under which criteria data/document could be used
People who do similar research
From where data/document is obtainable
It will be done by email with the person in charge of the project.
What processes are involved for a request to access data/document
Data is made available to individuals via email.
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