Objectives:evaluation the effect of aromatherapy and music on patients systolic and diastolic blood pressure,heart rate and anxiety during periodontal surgery.
study Design:This single center study for90 patients referring to the department of periodantics,scool of dentistry, shahid sadoughy university of yazd who wrer randomly divided in to three groups will be done.
Material and Methods:For the first group calming music will be played during surgery.in the second group 10 drops of the essential oil of lavandola will be used and the third group will recived no intervention.bllod pressure and heart rate of the patiens will be measured before and after surgery by digital pressure guage and anxiety level in patients will be measured by standard anxiety test(spiel berger).datas will ba analayzed with related software and tests.
inclusion criteriae:Inclusion critrriae for this study included informed consent to participate in the study,healthy hearing and smelling ability,no medical history of mood disorders,lack of systemic disorders such as cardiovascular disease and diabetes,no use od sedative-narcotic drugs and lack of drug addiction.
Interventions:use ofessential oil of lavandola and music.
main outcome measures:systolic blood pressure.diastolic blood pressure.Anxiety
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101324509N2
Registration date:2016-05-30, 1395/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-30, 1395/03/10
Registrant information
Name
Fahimeh Rashidi Maybodi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 519 6227
Email address
f-rashidi63@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Dentistry, shahid sadoughy university,yazd,iran
Expected recruitment start date
2016-01-17, 1394/10/27
Expected recruitment end date
2016-06-16, 1395/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music and aroma on patients' anxiety during periodontal surgery
Public title
The effect of music and aromatherapy on patients' anxiety during periodontal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: patient satisfaction; absence of defects in the senses of hearing and smelling; no medical history of mood disorders; cardiovascular disease or diabetes; no usage of sedative and analgesic drugs as well as a lack of drug addiction.
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
90
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
ethics comittee of Shahid Sadoughi University
Street address
Shahid Bahonar blv, Yazd
City
Yazd
Postal code
12345
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
IR.SSU.REC.1394.151
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F40
ICD-10 code description
phobic anxiety disorders
Primary outcomes
1
Description
Anxiety
Timepoint
before surgery, after surgery
Method of measurement
Depending on the answers to questions, a number considered to be
Secondary outcomes
1
Description
blood pressure
Timepoint
before surgery, a little while before ending of surgery
Method of measurement
Systolic and diastolic pressure
2
Description
Heart rate
Timepoint
before surgery, a little while before ending of surgery
Method of measurement
The number of beats you feel in minutes
Intervention groups
1
Description
aromatherapy( lavender smell)
Category
Treatment - Drugs
2
Description
Playing music
Category
Treatment - Other
3
Description
control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Shahid Sadouhi University
Full name of responsible person
Dr.jalali
Street address
Yazd - right Bahonar - Building No. 2 University - Research Department
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Houshang Mehrparvar
Street address
Bahonar square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Sadoughi 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
School of Dentistry, Yazd
Full name of responsible person
Dr. Fahimeh Rashidi Maybodi
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Dentistry, Yazd
City
Yazd
Postal code
17689
Phone
+98 357240171
Fax
Email
f-rashidi63@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences
Full name of responsible person
Mehrdad Jalali
Position
Student
Other areas of specialty/work
Street address
Dental Faculty of Shahid Sadoughi Uiversity
City
Yazd
Postal code
17689
Phone
+98 357240171
Fax
Email
mehrdad.jalali@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Yazd
Full name of responsible person
Mehrdad Jalali
Position
Student
Other areas of specialty/work
Street address
Dental Faculty of Shahid Sadougi University
City
Yazd
Postal code
17689
Phone
008357240171
Fax
Email
mehrdad.jalali@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)