Evaluation of music therapy effect on anxiety and pain level in impacted mandibular third molar surgery
Design
clinical trial has control group and also has parallel groups/single blinded/ on 102 patients/ randomised with statistical software
Settings and conduct
Location: Special clinic of Alborz Dental School
Patients are placed in one of three grops :1-control groups
2-Western classical music or 3- Iranian music.
after Completing the CORAH Dental Anxiety Assessment Questionnaire
they will be assessed for heart rate, blood pressure, and blood oxygen levels( 5 minutes before surgery, at the start of surgery, and in the middle of surgery ).24 and 48 hours after surgery, the level of perceptual pain will be recorded for them through oral and numerical pain scales.The surgeon will be blind in this study (all patients will have headphones.
Participants/Inclusion and exclusion criteria
inclusion criteria : patient in the age range of 18-30 - candidate for in impacted mandibular third molar surgery(mesioangular)
exclusion criteria:patient who is candidate for impacted wisdom tooth surgery and is out of the age range of 18-30 or the tooth is diagnosed as a C group and third class of Pell & Gregory's classification.also patients with systemic complications will be excluded duo to probable errors
Intervention groups
1-Intervention group 1 includes patients who are candidates for mandibular impacted wisdom tooth surgery who receive western classical music
2-Intervention group 2 includes patients who are candidates for mandibular impacted wisdom tooth surgery who receive Iranian classical music
3-The comparison group (control group) includes patients who are candidates for mandibular impacted wisdom tooth surgery who do not receive music.
Evaluation of music therapy effect on anxiety and pain level in impacted mandibular third molar surgery
Public title
Evaluation of music effect on anxiety and pain level in wisdom tooth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the age range of 18-30 years
impacted mandibular third molar (mesioangular)
Absence of active cardiovascular disease
Absence of normal auditory respiratory disease
Lack of disability and mental retardation
Exclusion criteria:
Age under 18 and over 30 years
Implanted wisdom tooth that is not mesiangular and is in group C and class 3 of Pell and Gregory classification
Existence of acute infection or swelling at the site during removal
Sensitivity to local anesthetic solution
Phobia and severe fear of the environment and dental treatment
Existence of active cardiovascular disease
Existence of active respiratory disease
Hearing problems
Disability and mental retardation
Prolonged surgical time longer than average minutes
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of samples to each of the three groups will be done by block randomization method with not similar blocks and randomization list using web at https://www.sealedenvelope.com/simple-randomiser/v1/ lists
will be provided
Blinding (investigator's opinion)
Single blinded
Blinding description
Surgeon: All patients will have headphones and the surgeon will not know which group the patient is in(We have three study groups in which patients in all three groups put headphones on their ears during surgery, music is played for two groups, and the control group does not receive music, so the surgeon does not know if the patient is receiving music or not because all patients have headphones)
Placebo
Not used
Assignment
Parallel
Other design features
he two intervention groups listen to music from different cultures, by analyzing the data, the cultural pre-familiarity with music on the surgical results is also examined.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of alborz university of medical sciences
5 minutes before surgery-at the start point of surgery-10 minutes after starting surgery
Method of measurement
heart rate and blood pressure: Digital sphygmomanometer -level of the blood oxygen:digital pulse oximeter(Physiological indicators of anxiety have been selected based on similar previous studies)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who are candidates for impacted wisdom tooth surgery and will receive Western classical music. Patients will receive Western classical music, which averagely has 60-80 beats per minute(5 minutes before the start of surgery until the end of it)
Category
Treatment - Other
2
Description
Intervention group: Patients who are candidates for impacted wisdom tooth surgery and will receive Iranian classical music. Patients will receive Iranian classical music, which averagely has 60-80 beats per minute(5 minutes before the start of surgery until the end of it)
Category
Treatment - Other
3
Description
control group:Candidate patients for mandibular impacted wisdom tooth who do not receive music (this group only puts headphones on their ears during surgery to blind the surgeon)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
dental clinic of alborz university of medical sciences
Full name of responsible person
Dr.Seyed Mostafa MOrtazavi
Street address
dental clinic, katoeizade street, golshahr
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5110
Email
melikaalishahi1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
dr seyed mostafa mortazavi
Street address
dental clinic, katoeizade street, golshahr
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5110
Email
melikaalishahi1373@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
alborz university of medical sciences
Proportion provided by this source
1
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
Karaj University of Medical Sciences
Full name of responsible person
melika alishahi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
dental clinic, katoeizade street, golshahr
City
Karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5110
Email
melikaalishahi1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
dr seyed mostafa mortazavi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
dental clinic, katoeizade street, golshahr
City
Karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5110
Email
ِDrmo_mortazavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
melika alishahi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
dental clinic-katoeizade street-golshahr
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5110
Email
melikaalishahi1373@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD