Comparison of Inhalation Scent of Lavendola and Benson relaxation for Anxiety in Patients with Major Depressive Disorder under ECT
Design
Clinical trial with two groups of intervention and control group, with parallel groups, blinded, randomized
Settings and conduct
This study was performed on 90 patients with major depression disorder in Ibn -Sina Hospital in Mashhad. They were selected on the basis of available sampling and randomly divided into three groups: control (30) and Benson relaxation intervention (30) Lavendula aroma (30 people) will be placed. The data gathering tool is Spielberger's anxiety questionnaire, which will be done in four stages one day before the intervention and after intervention before the first, third and six sessions of the ECT treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1- Mood disorders diagnosed by a psychiatrist
2- Ability of listening, speaking, and acceptable consciousness to answer questions.
3- lack of psychotic disorder at the time of the Electroconvulsive Therapy (ECT).
4- Aged 20 to 60 years and signed a consent form .
5- lack of olfactory disorder and sensitivity to the smell of lavender.
Exclusion criteria: 1- Less than four sessions of shock therapy at the time of the study.
2- The use of sedative drugs or any non-pharmacological method to reduce stress and fatigue during the intervention period.
3- Failure to comply with the study plan.
Intervention groups
Benson relaxation groups and groups with aromatherapy Lavendola routine intervention control group
Main outcome variables
anxiety
General information
Reason for update
Acronym
ECT
IRCT registration information
IRCT registration number:IRCT20181211041922N1
Registration date:2019-05-27, 1398/03/06
Registration timing:retrospective
Last update:2019-05-27, 1398/03/06
Update count:0
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
Reza Hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2055
Email address
hesarir941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Lavendola Inhalation aroma and Benson relaxation on Anxiety in Patients with Major Depressive Disorder under ECT
Public title
Comparison of the effect of Lavendola Inhalation aroma and Benson relaxation on Anxiety in Patients with Major Depressive Disorder under ECT
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A definitive diagnosis of major depressive disorder is given by the psychiatrist
No history of previous ECT
Would like to participate in the study
The level of upper secondary education is high
Speech and voice noproblems
Lack of physical illness leads to cognitive impairment
Lack of psychotic disorder during ECT
Lack of Mental retardation
There are no major medical and medical problems involved in the research
Anxiety disorder is not severe and not synchronous
Exclusion criteria:
Unwillingness of the family or patient to continue to collaborate and participate in research for any reason
If sensitized to the lavender extract
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with the help of throwing coins
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
NO
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Crossing Doctora, Street Ibn Sina University School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-10-04, 1397/07/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.033
Health conditions studied
1
Description of health condition studied
Major Depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Significant anxiety score in patients with major depressive disorder under ECT
Timepoint
The beginning of the study before intervention and after the intervention of the first and the sixth session of shock therapy
Method of measurement
Spielberger Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Usual care control group, such as fasting, voiding, and will be carried out jewelry and metals
Category
Other
2
Description
Intervention group 2: Benson relaxation technique: The Benson's muscle relaxation is performed by the patient in six steps. 1- Stay in a comfortable position 2. Close eyes. 3. Expansion the muscles of the body from the tip to the head 4. Performing the inhale through the nose and exhaling through the mouth and whisper the word desired when exhaling. 5- Perform the above steps for 20 minutes, then open the eyes and do not move for a few minutes. 6. Lack of worry and ignoring disturbing thoughts during relaxation. During the intervention, remove the disturbing thoughts from your mind as much as possible and choose a word that has always reminded him of calm, such as (God, love, sea). Instructions for doing these steps will be provided through the MP3 player and headphones. In this audio file, the instructions are set for 20 minutes and there is no need to set the clock to determine the method duration. In this file, 30 seconds before the completion of the technique, a gentle song will be put to inform the patient about the end of the procedure. To perform muscle relaxation by pulling the curtains at the patient's bed, the patient's privacy is observed and the privacy of the person and providing a quiet and silent environment for sitting with the department's officials is coordinated so that nobody gets into the patient's unit. One day after training the procedures In addition to the usual care of the department, Benson's relaxation procedure is performed once a day between the hours (6-8) for six consecutive days by patients and supervised by the researcher.
Category
Other
3
Description
Intervention group 1:Aromatherapy with lavender:Our point is an aroma of lavender extract in the form of an inhaler, in which people will be asked to smear two drops of 2% lavender smeared on 10-10 cm of gas and inhale it for at least 5 cm distance from the nose for 20 minutes.Patients will do this action Once a day, between 6:00 and 8:00 for six consecutive days.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abne Sina hospital
Full name of responsible person
Reza Hesari
Street address
Hor Amli Street, Bu'ali, Ibn Sina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195773391
Phone
+98 51 3711 2055
Email
www.HesariR941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Hesari
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, next to the Hovezeh cinema, Daneshgah avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9317744839
Phone
+98 51 3711 2055
Email
HesariR941@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reza Hesari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Education
Street address
Abne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195773391
Phone
+98 51 3711 2055
Email
www.HesariR941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Hesari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Department Of Science and Technology, Mashhad University Of Medical Sciences, Next to the Hoveyze Cinema, University Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9195773391
Phone
+98 51 3859 1511
Fax
Email
HesariR941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Hesari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Medical Education
Street address
Abne Sena Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195773391
Phone
+98 51 3711 2055
Email
www.HesariR941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available