Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349200
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-03-31
Brief Title:
Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients
Sponsor:
Dow University of Health Sciences
Organization:
Dow University of Health Sciences
Study Overview
Official Title:
Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients an RCT Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many patients suffer from dental anxiety and dont go to dentists for regular checkups This can lead to the initiation and progression of dental caries which if not controlled at the right time can lead to the loss of the tooth itself Many forms of distraction have been used to overcome this music is also one of them The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing root canal treatment in a dental teaching hospital The null hypothesis is that both binaural beats and 432 Hz-frequency music are not effective in reducing preoperative dental anxiety among patients undergoing routine endodontic therapy in a dental teaching hospital A total of three groups will be a part of this study with a total sample size of 99 participants 33 participants in each group Group A will listen to 432 Hz music for 10 minutes before the procedure Group B will listen to binaural beats for 10 minutes before the procedure and Group C active control group will listen to white noise for 10 minutes before the procedure The Visual Analog Scale for Anxiety will be used to assess the anxiety levels before local anesthesia administration after local anesthesia administration and 10 minutes after listening to sounds Then root canal treatment will be completed as a routine procedure
Detailed Description:
i Background Patients undergoing routine endodontic treatment often encounter severe preoperative and intraoperative anxiety that can increase the perception of pain intensity and decrease patients cooperation with the dentist Many audio distraction techniques have been used as a non-pharmacological means of anxiety reduction in dentistry for the past few years and they have shown great results
ii Objective The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing routine nonsurgical endodontic treatment in dental teaching hospital
iii Methodology In this randomized controlled clinical trial a total of 99 adult patients will be recruited and will be randomly divided into three groups based on the anxiety reduction method The first group n 33 will listen to music tuned to 432 Hz using wireless headphones The second group n 33 will listen to binaural beats using wireless headphones and the third group n 33 the control group will listen to white noise using wireless headphones All the patients will be informed about the procedure and anxiety will be measured using the Visual Analogue Scale before the administration of local anesthesia After the administration of local anesthesia a second measurement of anxiety level will be recorded After that the group A will be asked to listen to 432 Hz audios using wireless headphones group B will be requested to listen to binaural sounds using wireless headphones and the group C active control group will listen to white noise using wireless headphones After 10 minutes anxiety will be measured again using the Visual Analog Scale The root canal treatment will be completed in the usual way
vi Sequence Generation Participants will be randomized using a lottery method to either one of the interventional groups or the control group This method will ensure that each participant has an equal chance of being assigned to either group 99 small pieces of paper will be made 33 of them will have the letter A written on them 33 of them will have the letter B written on them and the remaining 33 will have the letter C written on them denoting their respective groups All of these chits will be folded four times and placed in a hat The participants will be asked to draw one piece of paper from the hat to be assigned to one group
vii Blinding The participants and outcome assessors will be blinded in this research double blinded The participants will not know about their group assignment or the intervention they will receive and the outcome assessors will not know about what intervention has been given to the patients
viii Allocation Concealment The lottery draw will be conducted by an independent person not involved in the study to ensure allocation concealment
ii Objective The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing routine nonsurgical endodontic treatment in dental teaching hospital
iii Methodology In this randomized controlled clinical trial a total of 99 adult patients will be recruited and will be randomly divided into three groups based on the anxiety reduction method The first group n 33 will listen to music tuned to 432 Hz using wireless headphones The second group n 33 will listen to binaural beats using wireless headphones and the third group n 33 the control group will listen to white noise using wireless headphones All the patients will be informed about the procedure and anxiety will be measured using the Visual Analogue Scale before the administration of local anesthesia After the administration of local anesthesia a second measurement of anxiety level will be recorded After that the group A will be asked to listen to 432 Hz audios using wireless headphones group B will be requested to listen to binaural sounds using wireless headphones and the group C active control group will listen to white noise using wireless headphones After 10 minutes anxiety will be measured again using the Visual Analog Scale The root canal treatment will be completed in the usual way
vi Sequence Generation Participants will be randomized using a lottery method to either one of the interventional groups or the control group This method will ensure that each participant has an equal chance of being assigned to either group 99 small pieces of paper will be made 33 of them will have the letter A written on them 33 of them will have the letter B written on them and the remaining 33 will have the letter C written on them denoting their respective groups All of these chits will be folded four times and placed in a hat The participants will be asked to draw one piece of paper from the hat to be assigned to one group
vii Blinding The participants and outcome assessors will be blinded in this research double blinded The participants will not know about their group assignment or the intervention they will receive and the outcome assessors will not know about what intervention has been given to the patients
viii Allocation Concealment The lottery draw will be conducted by an independent person not involved in the study to ensure allocation concealment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None