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Study of orange's odor effectiveness on reduction patient's anxiety for mandibular third molar surgery

Protocol summary

Summary
Objective:study of orange's odor on referring patient's stress for wisdom tooth surgery in Isfahan Afzal clinic. Designing:random and single blind. Inclusion criteria :Volunteer; healthy smell;9< DAS>14 Exclusion criteria:smoking;surgery's difficulty degree must not B2;person's age>45 In check up session,persons are filled DAS questionnaire in during the time of 5 min and persons that their stress is between 9 to 14 ,are entered to study.patient's are divided to in 2 groups,each group contains 28 persons (A total :58 patient). In therapy session,for two groups,we check patient's vital signs that include Blood pressure,heart beat and number of patient's respiration at 5 time.(2 time in waiting room :at the time of patient's entry to clinic and 10 min afterward,before anesthesia,before surgery,after surgery). for case group 25 ML(equal to 5 drops) of orange essence is poured in 5 Lit cold vapor device and before coming of patient,the odor in distributed in the air and in the whole of therapy session(in waiting & surgery room) the odor is distributing. for control group ,without odor distribution, therapy session is done. patient vital signs in two group is drawn in diagrams,we investigate acquired changes and effect of orange odor on decreasing of patient stress.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201212277949N3
Registration date: 2013-01-29, 1391/11/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-29, 1391/11/10
Registrant information
Name
Daryosh Hasheminia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2882
Email address
d_hasheminia@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of orange's odor effectiveness on reduction patient's anxiety for mandibular third molar surgery
Public title
Study of orange's odor on surgical patient's anxiety
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria :Volunteer; healthy smell;9< DAS >14 Exclusion criteria:smoking;surgery's difficulty degree must not B2;person's age>45
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sience
Street address
University St,Azadi Square
City
Isfahan
Postal code
Approval date
2011-10-17, 1390/07/25
Ethics committee reference number
391286

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F40
ICD-10 code description
Specific (isolated) phobias

Primary outcomes

1

Description
anxiety
Timepoint
In the waiting room, before anesthesia, before surgery, after surgery
Method of measurement
blood pressure,MmHg, by using brachial pressure, heart rate, pulses per minute by pulse oximetr,number of respiration; using objective observation by the number of breaths per minute

Secondary outcomes

empty

Intervention groups

1

Description
for case group ,25 Ml (equal 5 drop) of orange essence is poured in 5 Lit cold vapor device and before coming of patient,the odor is distributed in the air. in the whole of therapy session (in waiting & surgery room ),the odor is distributing.
Category
Other

2

Description
for control group :without odor distribution,therapy session is done .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzal dentistry clinic
Full name of responsible person
Dr Daryush Hasheminia
Street address
Soroush St, Ahmad abad Square
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Savabi
Street address
University St, Azadi Square, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Science
Full name of responsible person
Fatima Karimi
Position
student
Other areas of specialty/work
Street address
No.91, Lane 31, Navab safavi St
City
Ardakan
Postal code
Phone
+98 35 2723 6549
Fax
Email
fk84125@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan of Medical Sience
Full name of responsible person
fatima karimi
Position
Dentistry student
Other areas of specialty/work
Street address
No.91, Lane 31, Navab safavi St
City
Ardakan
Postal code
Phone
+98 35 2723 6549
Fax
Email
fk84125@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sience
Full name of responsible person
daryosh hasheminia
Position
PhD
Other areas of specialty/work
Street address
University St,Azadi Square
City
Isfahan
Postal code
Phone
+98 31 1792 2812
Fax
Email
d_hasheminia@dnt.mui.ac.irfk84125@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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