Protocol summary

Summary
The aim of this study is evalution of effect of saliva cortisol after smelling of orange oil.Inclusion criteria:healthy patients with 20-45 years old. Exclusion criteria:Systemic disease;taking medication and phsycologic disorder.The study population 30 patients that referred to dental school for class I restoration that devided in two groups. intervention group :after smelling of orange oil the saliva is collected before injection ,between and the end of treatment for evaluation of saliva cortisol .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071625819N3
Registration date: 2016-12-26, 1395/10/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-26, 1395/10/06
Registrant information
Name
Somaye Salari Sedigh
Name of organization / entity
Rafsanjan Dental school
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0030
Email address
s_salarisedigh@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Science
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of using orange essential oils in the environment on stress management through salivary cortisol measurement in patients referred to the Rafsanjan dental clinics in 2016
Public title
Effect of orange oil on stress value in dentistry
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:Having aged between 20 and 45 years Exclusion criteria:Systemic disease;taking medication;infectious disease;Adrenal gland failure;Hormonal disorders and mood disorders
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Imam Ali Boulevard, Central Intelligence Agency
City
Rafsanjan
Postal code
7717933777
Approval date
2016-05-16, 1395/02/27
Ethics committee reference number
IR.RUMS.REC.1395.45

Health conditions studied

1

Description of health condition studied
Effect of orange essential oil on stress
ICD-10 code
E27
ICD-10 code description
Other disorders of adrenal gland

Primary outcomes

1

Description
stress
Timepoint
Before dentistry treatment- after anesthesia- After dentistry treatment
Method of measurement
Measurement of stress through determination of salivary cortisol by centrifuge samples in the laboratory

Secondary outcomes

1

Description
decrease of pain
Timepoint
before anesthesia whitin dental work after anesthesia
Method of measurement
threshold of patients pain

Intervention groups

1

Description
25 ml orange essential oil distribution in intervention group in the first session by 5-liter cool-mist humidifier during dental treatment done
Category
Diagnosis

2

Description
In control group dont use any oil.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Rafsanjan Dental College
Full name of responsible person
Somaye Salari Sedigh
Street address
Rafsanjan, Ali Ibn Abi Talib Hospital of Rafsanjan Boulevard near the western Mofateh
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
financial assistance of rafsanjan university of medical science
Full name of responsible person
Dr.ali ravari
Street address
Bolvar Emam Ali
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
financial assistance of rafsanjan university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rafsanjan university of medical Sciences
Full name of responsible person
Somaye salari sedigh
Position
Assistant Professor
Other areas of specialty/work
Street address
Rafsanjan, Ali Ibn Abi Talib Hospital of Rafsanjan Boulevard near the western Mofateh
City
Rafsanjan
Postal code
7716614618
Phone
+98 34 3322 0031
Fax
Email
s_salarisedigh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan university of Medical Sciences
Full name of responsible person
Somaye salari Sedigh
Position
Assistant Professor
Other areas of specialty/work
Street address
Rafsanjan, Ali Ibn Abi Talib Hospital of Rafsanjan Boulevard near the western Mofateh
City
Rafsanjan
Postal code
7716614618
Phone
+98 34 3322 0031
Fax
Email
s_salarisedigh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Somaye salari sedigh
Position
Assistant Professor
Other areas of specialty/work
Street address
Rafsanjan, Ali Ibn Abi Talib Hospital of Rafsanjan Boulevard near the western Mofateh
City
Rafsanjan
Postal code
7716614618
Phone
+98 34 3428 0030
Fax
Email
ssalarisedigh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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