Determination of the effect of aromatherapy with Melissa officinalis L. on anxiety and Physiologic parameters of patients candidate for coronary angiography and their spouses at Koosar hospital of Semnan city.
Design
The second phase of the clinical trial with control groups and a parallel group design that will be conducted by age stratified (18-45 years and older than 45 years) randomized block design with a sample size of 72 couples.
Settings and conduct
This study will be done at men internal ward of Koosar hospital in Semnan city.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes: age of 18 and above, Literacy at least end of elementary education, being married, No previous history of coronary angiography, healthy olfactory sense, No drug addiction, No history of asthma and allergies.
Exclusion criteria includes: Use of sedatives and anxiolytic drugs, Use of any perfume or fragrance
Intervention groups
Intervention group 1: 36 male with eligible criteria.
Intervention group 2: 36 wives of intervention group 1 participants.
Control group 1: 36 male with eligible criteria.
Control group 2: 36 wives of control group 1 participants.
Intervention, involves inhaling a cotton ball impregnated with 3 drops of 1% essential oil of Melissa Officinalis L. (manufactured by Abatage Pharmaceutical Company) attach to the collar of the cloth for 20 minutes. The control groups will use a cotton ball impregnated with sterile water attach to the collar for 20 minutes.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
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IRCT registration information
IRCT registration number:IRCT20140721018550N8
Registration date:2020-01-28, 1398/11/08
Registration timing:prospective
Last update:2020-01-28, 1398/11/08
Update count:0
Registration date
2020-01-28, 1398/11/08
Registrant information
Name
Nayyereh Raiesdana
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 3867
Email address
nr_dana@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Aromatherapy with Melissa Officinalis L. on Anxiety of Patients candidate for coronary angiography and their spouses
Public title
ٍEffects of Aromatherapy with Melissa Officinalis L. on Anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Literacy at least end of elementary education
Being married
No previous history of coronary angiography
No olfactory deficiency
No previous history of asthma and allergies
No addiction
Exclusion criteria:
Use of sedatives or anxiolytic drugs
Use of any perfume and fragrance
Severe changes in vital signs or medical condition
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
More than 1 sample in each individual
Number of samples in each individual:
2
36 eligible men and their spouses were included in the intervention groups and 36 eligible men and their spouses were placed in the control groups.
Randomization (investigator's opinion)
Randomized
Randomization description
To ensure matching between the two groups as well as to achieve a completely random and balanced assignment, we will use a randomized classification using Stratified permuted block randomization. Individuals are then divided into two stratum of age 18-45 years and over 45 years, and for each class a separate random assignment is continued until the sample size is reached. For random assignment in each class based on different sequences of two methods A (intervention) and B (control), 6 blocks are defined and numbered from left to right from 1 to 6. Then using 1 to 6 random blocks of blocks are randomly selected. (Numbers 0, 7, 8 and 9 are not decided). Thus, the assignment type is determined from left to right, respectively. Since we need 36 pairs in each group, we have to randomly select the block 9 times for that class).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
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
Semnan University of Medical Sciences, Basij Bolverd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.SEMUMS.REC.1398.157
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F09
ICD-10 code description
Mental disorders due to known physiological conditions
Non-invasive blood pressure measurement with Monitoring SAADAT
2
Description
Pulse rate
Timepoint
Before and after intervention
Method of measurement
Monitoring SAADAT
3
Description
O2 Saturation
Timepoint
Before and after intervention
Method of measurement
Pulse Oximeter Monitoring SAADAT
4
Description
Body temperature
Timepoint
Before and after intervention
Method of measurement
Digital Tympanic Thermometer (Beurer Mark)
Intervention groups
1
Description
Intervention group 1: Participants will inhale 3 drops of 1% essence of lemon balm on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments.
Category
Prevention
2
Description
Intervention group 2: Participants will inhale 3 drops of 1% essence of lemon balm on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments.
Category
Prevention
3
Description
Control group1: Participants will inhale 3 drops of sterile water on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments.
Category
Placebo
4
Description
Control group 2: Participants will inhale 3 drops of sterile water on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Kowsar hospital
Full name of responsible person
ِDr.Mohammad Memarian
Street address
َAmin Blvd.,Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3104 3200
Email
draria2018@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz kokhaei
Street address
Deputy of Research and Technology, Semnan University of Medical Sciences, Basij boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
kokhaei@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
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
َAssisstant professor.Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Faculty member(Assisstant professor)
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nr_dana@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
َAssistant professor.Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@semums.ac.ir
Web page address
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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