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Effect of implementing relaxing music and aromatherapy on anxiety in patients undergoing root canal therapy

Protocol summary

Study aim
The effect of aromatherapy and relaxing music on anxiety index and vital signs during dental treatment
Design
A randomized controlled clinical trial with parallel, single-blind, randomized groups
Settings and conduct
‏72patient sampling method will be selected from patients referring to root canal treatment in Afz Esfahan Dental Clinic based on inclusion criteria. Control group(group one), patients treated with lavender aroma (group two),patients treated with music listening (group three), patients treated with lavender aroma and music listening(group four) ‏None of the patients were given any explanation about the effects of music and the aroma of lavender on their anxiety in order to avoid the psychological and placebo effects. Patients fill out the Dental Anxiety Questionnaire before starting treatment. Their blood pressure and heart rate will be measured in two stages before and after treatment.
Participants/Inclusion and exclusion criteria
Patients referred to the Specialty Clinic of Dentistry will be selected at the examination session for patients with irreversible pulpitis, in terms of healthy olfactory and hearing, non-smoker, non-pregnant, no history of allergies, cardiovascular disease, diabetes and mental disorders.If patient is not willing to cooperate during treatment session, colds, allergies, painkillers, sedation, emergency treatment during treatment, injection of more than one carpal anesthetic, prolonged treatment, patient from The study will be deleted.
Intervention groups
Control,Music,Lavender Aroma,Music and Lavender Aroma
Main outcome variables
Decrease in cardiovascular parameters and anxiety during treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191228045910N1
Registration date: 2020-06-21, 1399/04/01
Registration timing: retrospective

Last update: 2020-06-21, 1399/04/01
Update count: 0
Registration date
2020-06-21, 1399/04/01
Registrant information
Name
fateme nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5742 2950
Email address
f.nasiri.8090100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-01, 1398/10/11
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of implementing relaxing music and aromatherapy on anxiety in patients undergoing root canal therapy
Public title
Effect of implementing relaxing music and aromatherapy on anxiety in patients undergoing root canal therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the Special Clinic of Dentistry patients with irreversible pulpitis in terms of healthy olfactory in terms of healthy hearing non-smoker non-pregnant no history of allergies no history of cardiovascular disease no history of diabetes no history of mental disorders
Exclusion criteria:
If patient is not willing to cooperate during treatment session common colds allergies painkillers or sedative medication injection of more than one carpal anesthetic prolonged treatment emergency during treatment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
For individual Randomization We will add 72 patients to the desired population size. Then we have 2 single-digit columns in the table of random numbers. We will then randomly select a starting point for patient selection. Finally, we started the selection process from this point and considered any number that is smaller or equal to 72 as the sample of choice
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the patients are given any explanation about the effects of music and lavender aromas on their anxiety in order to avoid the psychological and placebo effect.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Isfahan University of Medical Sciences
Street address
Hezar jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-12-04, 1398/09/13
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.526

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety Disorder

Primary outcomes

1

Description
blood pressure
Timepoint
Before and after treatment
Method of measurement
Digital blood pressure monitor

Secondary outcomes

1

Description
Pulse rate
Timepoint
Before and after treatment
Method of measurement
Digital pulse detector

2

Description
Anxiety
Timepoint
before and after treatment
Method of measurement
Questionnaire

Intervention groups

1

Description
Control group: Five drops of water as placebo dispersed in an electronic deodorizing chamber in an area of ​​20square meters during the treatment (30-60 minutes).
Category
Placebo

2

Description
Intervention group: music listening during treatment (30-60 minutes) via external spaekers
Category
Treatment - Other

3

Description
Intervention group: Five drops of lavender essential oils produced by Kazerun Agro Company at a concentration of 2% and containing emulsifiers dispersed in an electronic deodorizing chamber in an area of ​​20square meters during the treatment (30-60 minutes).
Category
Treatment - Other

4

Description
Intervention group: Intervention # 1 and # 2 are performed simultaneously
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzal private clinic,isfahan dental faculty
Full name of responsible person
Seyed Amir Mousavi
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5742 2950
Email
mousavi@dnt.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Nosouhian
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Email
Nosouhian@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Nasiri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5742 2950
Email
f.nasiri.8090100@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Nasiri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5742 2950
Email
F.nasiri.8090100@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Nasiri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5742 2950
Email
F.nasiri.8090100@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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