Evaluation and comparison of European classical music and Iranian classical music on pain and anxiety level of dental patients.
Design
Randomized controlled clinical trial with 3 parallel groups designed of 90 participants
Randomization sequence carried out by using a table of computer generated
random numbers
Settings and conduct
The study will be carried out in private dental office on 90 patients undergoing root canal treatment. Participants will be allocated randomly in 3 groups of instrumental piano European classical music, instrumental piano Iranian classical music and no music as control group. In each group playing music via loudspeaker will be started since 5 minutes prior dental treatment until treatment completion. State-Trait Anxiety Inventory is used for stress level assessment before, during and after dental treatment. Pulse rate and respiratory rate are measured before, during and after dental treatment. Pain level following dental anesthesia injection is assessed by visual Analog Scale
Participants/Inclusion and exclusion criteria
Inclusion criteria: People aged between 18 to 65 years old with health status ASA 1 or 2; Exclusion criteria: People with nervous or psychiatric diseases and people who take nervous or psychiatric medications
Intervention groups
In two study groups, patients listen to Iranian classical or European classical music during dental treatment. In control group dental treatment will be done in silence.
Evaluation and comparison of European classical music and Iranian classical music on pain and anxiety level of dental patients.
Public title
Comparison of European classical music and Iranian classical music on anxiety level
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adults between 18 to 65 years old with medical condition ASA 1 and 2
Exclusion criteria:
People with nervous and psychiatric disorders
People who take neurology and psychiatry medication
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using stratified block randomization. First participants are allocated into homogeneous ternary blocks based on main background variables. Then in each ternary block, participants are randomly allocated to one of the study groups.
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
Ethics Committee of Mashhad University of Medical Sciences