Protocol summary

Study aim
Investigating the Effect of Aromatherapy on Herbal Remedies
Design
A clinical Trial with a Randomized, Randomized, Randomized, Randomized, Control Group
Settings and conduct
32 Female High school Students who Were Interviewed and Controlled inTwo Groups of 16 and Under a Clinical Trial using Three Herbal Remedies for 30 Working Days at a Specific Time with Placebo in the Control Group were Blinded. Students were Given only Detailed Information on the Herbal Remedy and its Function in the Body
Participants/Inclusion and exclusion criteria
The High school Entry Conditions of 16 to 17Years of Age Were 94-95. Conditions for not Getting all Boys
Intervention groups
A Combination of Three Notes of Rose, Lavender, Rosemary with Specific Dosage on 16 High school Girl Students Study of the Effect of Placebo (Sweet Almond Oil) in the Control Group for 30 Working Days
Main outcome variables
Combines Three Notes of Rose, Lavender and Rosemary

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180924041123N2
Registration date: 2018-12-29, 1397/10/08
Registration timing: retrospective

Last update: 2018-12-29, 1397/10/08
Update count: 0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
mehrafarin abolhasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4324 5362
Email address
sabolhasani61@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-18, 1394/10/28
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
2016-01-18, 1394/10/28
Actual recruitment end date
2016-01-21, 1394/11/01
Trial completion date
2016-02-22, 1394/12/03
Scientific title
Effect of Aromatherapy on Anxiety in High school Girl Students
Public title
Investigating the Effect of Aromatherapy on Herbal Remedies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at Least 16 Year Old and 17 Year Old in Maximum Girl Dosn,t Have Any Allergy to Medicinal Plants Which Use During Experiencing Period
Exclusion criteria:
Ageing Conditions Gender of Prticipants Who Be Boy Allergy to Medicinal Plants
Age
From 16 years old to 17 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random,and Also Participants Have Concluded in to Tow Groups Randomly; Interfiering and Control Group
Blinding (investigator's opinion)
Single blinded
Blinding description
At the First Session, Abrief Explanation was Given to Students about Traditional Medicine and the Implementation of Psychological Tests, and Students were Asked to Give the Best Answer they Thought is Correct and to Inhale and Recapture over 30 Days Handkerchiefs Containing Aromatic Substances. They were TestedNote the attention that students did not know about the topic of research and only knew that the topic of research was related to psychology and aromatherapy.
Placebo
Used
Assignment
Factorial
Other design features
The Statistical Group Was The High School Girls (16_17)Who Had Educafed in Dorud in 1394_95 Eduction Years .The Sample of Study Was 32 Student Who Mentioned Included in to Two Experimental and Control Group Randomly (16 Students in each Group).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad Unversity Borujerd
Street address
Islamic Azad University Squar
City
Borujerd
Province
Lorestan
Postal code
6881745768
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
IR.IAU.B.REC

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The Study of Aromatherapy on Girls at High School According to Anxity to Anxity Test
Timepoint
The Effect of Aromatherapy on Anxity in 30 Days at 8 in the Morning Through 20 Minutes Beside Tow days for Doning Anxity Test.
Method of measurement
In Order to Data Collection in Used Beck(1990) Anxity After That to Analysis The data Used Mancova covalent Analysis.

Secondary outcomes

1

Description
Aromatherapy
Timepoint
The Effect of Aromatherapy on Anxity in 30 Days at 8 in The Morning Throught 20 Minutes Beside Two Days for Doing Anxity Test.
Method of measurement
After That to Analysis The Data Used. Mancova Covalent Analysis.

Intervention groups

1

Description
Intervention group: 16 students Have Inserted in Intervention Group Simple Randomly After The Anxiety Test by Beck During 30 days at 8 in The Morning Had Taken Another Test After 30 Days The Students Have Breathe Three Selected Smells (Rosemary,Roses,Spike Lavender) Through lissue Every Day by 20 Minutes.
Category
Treatment - Drugs

2

Description
Control group: 16 of Control Group Have Inserted in Cntorol Group Simple Randomly After The Anxiety Test During 30 Days 8 In The Morning Had Taken Another Test After 30 days Through Perfumed Tissus as Plasibo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Girls High School Hadis
Full name of responsible person
Mehrafarin Abolhasani
Street address
Alghadir Stret
City
Dorud
Province
Lorestan
Postal code
6881745768
Phone
+98 66 4324 5362
Email
sabolhasani61@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrafarin Abolhasani
Street address
No 45768, Bahar 14, Alghader Ave
City
Dorud
Province
Lorestan
Postal code
6881745768
Phone
+98 66 4324 5362
Email
sabolhasani61@gimail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Azad Eslamic University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Mehrafarin Abolhasani
Position
Clinical Psycologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Alghader Ave
City
Dorud
Province
Lorestan
Postal code
6881745768
Phone
+98 66 4324 5362
Email
sabolhasani61@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrafarin Abolhasani
Position
Clinical Psycologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Alghadir Ave
City
Dorud
Province
Lorestan
Postal code
6881745768
Phone
+98 66 4324 5362
Email
sabolhasano61@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrafarin Abolhasani
Position
Clinicl Psycologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Alghader Ave
City
Dorud
Province
Lorestan
Postal code
6881745768
Phone
+98 66 4324 5362
Email
sabolhasani61@gmail.com

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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Printable is Part of The Research Results.
When the data will become available and for how long
After Printing in Journals 6 Months
To whom data/document is available
Researchers Working inuniversitiys
Under which criteria data/document could be used
Printed in Prestigious Magazines
From where data/document is obtainable
Mehrafarin Abolhasani
What processes are involved for a request to access data/document
After 3 Month Receive Emil
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