Protocol summary

Summary
For most of patients dental environment is always an stressful place, because of some reasons such as fear of anesthesia and a history of past painful treatments .the purpose of this study is to explore the Effect of music therapy on pain and anxiety in patients undergoing root canal treatment in dental clinic. method and materials: 60 patients who came to a dental clinic for endodontic treatment were selected for this study. The subjects were randomly assigned to the music intervention and the control group.not having hearing defects and any other systemic problems and not using any sedative or analgesic drugs are the most important inclusion criteria.Subjects in the music group listened to selected music using headphones throughout the root canal treatment procedure but the control group subjects didn't . the subjects’ heart rate, blood pressure were measured before the study, after anesthesia, during and end of the root canal treatment procedure .Patients completed the anxiety questionnaire both before and after the procedure and reported pain severity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205209805N1
Registration date: 2012-05-30, 1391/03/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-30, 1391/03/10
Registrant information
Name
Sara Mohammadi Sepahvand
Name of organization / entity
Dental Faculty, Lorestan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1322 4165
Email address
smohammadis66@gmail.com
Recruitment status
Recruitment complete
Funding source
Dental Research Center, School of Dentistry, Isfahan University of Medical Science
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of music therapy on pain and anxiety in patients undergoing root canal treatment
Public title
Effect of music therapy on anxiety and pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patient who has a tooth with endodontic treatment need; agree to participate in this investigation; no hearing problems; without heart problem and any other systemic problems such as immune suppressive diseases; non-pregnant females; ability to endure local anesthesia ; not using any sedative or analgesic drugs; without any Psychiatric Disorders. exclusion criteria:patient who refuse to continuing the treatment; patient who need complicated treatment during the endodontic procedure; having systematic problems dusring the treatment; endodontic procedure more than one hour
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
dental faculty ,Isfahan University Of medical science
Street address
School of Dentistry, Isfahan University of Medical Science, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2011-10-17, 1390/07/25
Ethics committee reference number
290249

Health conditions studied

1

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

2

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

Primary outcomes

1

Description
pain
Timepoint
at the end of procedure
Method of measurement
visual analoge scale

2

Description
anxiety
Timepoint
before and after procedure
Method of measurement
questionnaire

Secondary outcomes

1

Description
systolic blood pressure
Timepoint
before procedure,after anesthesia,during and after prosedure
Method of measurement
Arm-type blood pressure monitor

2

Description
diastolic blood pressure
Timepoint
before procedure,after anesthesia,during and after prosedure
Method of measurement
Arm-type blood pressure monitor

3

Description
heart rate
Timepoint
before procedure,after anesthesia,during and after prosedure
Method of measurement
Arm-type blood pressure monitor

Intervention groups

1

Description
patients in intervention group listened to selected music using headphones throughout the root canal treatment procedure.
Category
Treatment - Other

2

Description
patients in control group just using headphones without listening to any type of music throughout the root canal treatment procedure.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
َAfzal dental clinic
Full name of responsible person
Dr.Seyyed Hamidreza Razavian
Street address
Soroush Street,Ahmadabad square,Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan university of medical science
Full name of responsible person
Dr.Omid Savvabi
Street address
Isfahan university of medical science
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 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
dental faculty
Full name of responsible person
Dr.Seyyed HamidReza Razavian
Position
endodontist,Assistant Professor of Endodontics
Other areas of specialty/work
Street address
dental faculty,Isfahan University Of medical Science,Hezar jerib street,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1624 3998
Fax
Email
hamidrazavian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
dental faculty
Full name of responsible person
Dr.Behnaz Barekatain
Position
Endodontist,Assistant Professor of Endodontics
Other areas of specialty/work
Street address
5th floor,Kongereh building,Abuzar street
City
Isfahan
Postal code
Phone
+98 31 1236 2316
Fax
Email
Barekatain@dnt.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of medical science
Full name of responsible person
sara mohammadi sepahvand
Position
dentistry student
Other areas of specialty/work
Street address
No.52,9th Arasteh alley,Enghelab street
City
Khorram abad
Postal code
6816834677
Phone
+98 66 1322 4165
Fax
Email
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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