Investigating the effect of permitted music on reducing anxiety, heart rate and blood pressure in patients undergoing mandibular third molar tooth surgery in the specialized department of the faculty of dentistry and special clinic in Isfahan in 1403
Determining the effect of favorite music on reducing anxiety, heart rate and blood pressure in patients undergoing dental surgery
Design
This study is a randomized controlled clinical trial conducted on patients aged 20-35 years who are candidates for dental surgery in 1403 AH at Isfahan Dental School. Among the eligible patients, 120 patients will be included in the study. Patients will be divided into two groups of 60 using random allocation software: the intervention group will listen to their favorite music with hands-free headphones, and the control group will receive standard care.
Settings and conduct
The statistical population includes all patients who are candidates for dental surgery and have referred to the specialized surgical department of the School of Dentistry and the Isfahan Special Clinic.
Before surgery, patients complete the MDAS questionnaire and their blood pressure and heart rate are recorded. During surgery, music is played for the intervention group and their blood pressure and heart rate are recorded. After surgery, patients complete the MDAS questionnaire again and their blood pressure and heart rate are recorded, and satisfaction is assessed with a VAS scale.
Participants/Inclusion and exclusion criteria
Entry requirements: Patients between 20 and 35 years of age who have referred to the specialized surgery department of Isfahan Faculty of Dentistry and Special Clinic for dental surgery and do not have any specific diseases.
Conditions of non-entry: failure to answer more than 20% of the questions in the questionnaire
Incomplete surgery for various reasons
Patients with unusual fear of dentistry (phobia)
Prolonged surgery
Intervention groups
Using patients' favorite music to check the effect on reducing anxiety, blood pressure and heart rate
Main outcome variables
Playing music during dental surgery reduces anxiety levels and increases patient satisfaction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250217064756N1
Registration date:2025-04-20, 1404/01/31
Registration timing:registered_while_recruiting
Last update:2025-04-20, 1404/01/31
Update count:0
Registration date
2025-04-20, 1404/01/31
Registrant information
Name
mohamadhossein manouchehri naeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5554
Email address
mh.manouchehri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-14, 1404/01/25
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of permitted music on reducing anxiety, heart rate and blood pressure in patients undergoing mandibular third molar tooth surgery in the specialized department of the faculty of dentistry and special clinic in Isfahan in 1403
Public title
Investigating the effect of permitted music on reducing anxiety, heart rate and blood pressure in patients undergoing mandibular third molar tooth surgery in the specialized department of the faculty of dentistry and special clinic in Isfahan in 1403
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the dental school who do not have specific diseases
Exclusion criteria:
Patients with unusual fear of dentistry (phobia)
Incomplete surgery for various reasons
Prolonged surgery
Failure to answer more than 20% of the questionnaire questions
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups of 60 using random allocation software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Dentistry, Health Sciences and Advanced Medical Technologie
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Dentistry
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2025-02-03, 1403/11/15
Ethics committee reference number
IR.MUI.DHMT.REC.1403.204
Health conditions studied
1
Description of health condition studied
Investigating the effect of permitted music on reducing anxiety, heart rate and blood pressure in patients undergoing mandibular third molar surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of anxiety
Timepoint
Before and after surgery
Method of measurement
MDAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Playing the patient's favorite music playlist
Category
Other
2
Description
Control group: Participants in this group will receive standard care, which includes anesthesia and verbal sedation from the dental team.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Isfahan
Full name of responsible person
Seyyed Mohammad Razavi
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Dentistry
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5500
Email
mh.manouchehri90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hazar Jarib Street, Aluk Medical University of Isfahan, Faculty of Dentistry
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5500
Email
mh.manouchehri90@gmail.com
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
Mohammad Hossein Manouchehri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Dentistry
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5500
Email
mh.manouchehri90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Manouchehri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Dentistry
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5500
Email
mh.manouchehri90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Manouchehri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Dentistry
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5500
Email
mh.manouchehri90@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