Comparison of the effectiveness of the music therapy with and without virtual reality in reducing the anxiety of patients undergoing implant surgery in a parallel randomized controlled trial
General purpose:
Comparing the effectiveness of music therapy with and without virtual reality glasses in reducing anxiety in patients undergoing Implant surgery in the Department of Dental Implants of Tehran School of Dentistry in a parallel randomized clinical controlled trial study.
Design
Clinical trials with control group, with parallel groups, one-blind, randomized, were used on 28 patients, for randomization of Microsoft Excel software.
Settings and conduct
This study is conducted in the Implant Department of Tehran University of Medical Sciences. Patients are selected randomly divided into control or intervention group. Patients receive relaxing music during surgery. Patients in the intervention group, in addition to relaxing music, also receive nature video by VR glasses. The anxiety score of patients in both groups is measured by MDAS questionnaire before and after surgery. Blood pressure of patients before and after surgery is measured. The heart rate of patients before, during and after surgery is measured. In this study, analyzers are blinded. In this way, data is delivered to the analyzers as A and B codes.
Participants/Inclusion and exclusion criteria
exclusion criteria: the age of the patient is between 18 and 70 years and the patient is satisfied with the study.
exclusion criteria: Mental Disease; Synchronous treatment with sinus surgery; Consumption of all types of blood pressure controllers or cardiac drugs or types of benzodiazepines everyday; Need to treat broad bone marrow; Complex surgicals such as the number of implants above 4 and more than one hour and a half
Intervention groups
Control group: Perform implant surgery with sedative music playback
intervention group: Perform implant surgery with sedative music playback and video playback from nature by virtual reality glasses(VR)
Main outcome variables
.Blood pressure; Heartbeat; Questionnaire MDAS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240714062433N1
Registration date:2025-04-23, 1404/02/03
Registration timing:retrospective
Last update:2025-04-23, 1404/02/03
Update count:0
Registration date
2025-04-23, 1404/02/03
Registrant information
Name
Zahra Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2295 5981
Email address
nooriyalda106@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-02, 1403/08/12
Expected recruitment end date
2024-11-17, 1403/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of the music therapy with and without virtual reality in reducing the anxiety of patients undergoing implant surgery in a parallel randomized controlled trial
Public title
Comparison of the effectiveness of the music therapy with and without virtual reality in reducing the anxiety of patients undergoing implant surgery in a parallel randomized controlled trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing implant surgery (18 to 70 years old) if the patient consents to participate in the study.
Exclusion criteria:
The patient is being treated for any type of mental illness, especially anxiety.
Patients undergoing closed sinus transplant treatment with the osteotom method (due to the use of trauma).
Patients who take blood pressure control drugs or heart drugs or benzodiazepines on a daily basis.
Patients who need extensive bone grafting during surgery. (Because the dimensions of the VR glasses may hinder the comfortable operation of the surgeon.)
Patients who need more than 4 implants.
Complex surgeries that require more than an hour and a half from the start of surgery.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
How to prepare the randomization list:
Random allocation is done by balanced block allocation method. The software used will be Microsoft Excel. The size of the blocks will be determined by the generator of the random allocation list without informing others.
How to hide:
The allocation code of the patients to the two studied groups is placed in invisible numbered envelopes. This envelope is opened for each patient before anesthesia. To analyze random allocation data, it is entered into the software with random code A and B. This code is decoded after statistical analysis and interpretation of the findings by a person unrelated to the study.
Randomization implementation process:
The envelope is opened by the person responsible for allocating the code to the patients. Random allocation and entering the allocated data is done by a person unrelated to the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyzer is masked. The data is delivered to the analyst with statistical codes of A and B, so only the data of A and B are delivered to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Faculty of Dentistry, Tehran University of Medical Sciences. North kargar Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2024-10-20, 1403/07/29
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.103
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score based on MDAS questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and after the end of the surgery, until half an hour later
Method of measurement
modified dental anxiety scale questionnaire
Secondary outcomes
1
Description
heartbeat
Timepoint
After the patient sits on the unit, before anesthesia injection and immediately after surgery
Method of measurement
pulse oximeter
2
Description
blood pressure
Timepoint
After the patient sits on the unit, before anesthesia injection and immediately after surgery
Method of measurement
pressure gauge
Intervention groups
1
Description
Intervention Group: This group uses music therapy (a number of pre -defined relaxing music by the Bluetooth headset for the patient) and the distribution of nature by virtual reality glasses VR) are used to reduce patients' anxiety.
Category
Behavior
2
Description
Control Group: This group uses music therapy (a number of pre -determined relaxing music by Bluetooth headset for the patient) to reduce patient anxiety.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry Tehran University of Medical Sciences
Full name of responsible person
Soolmaz Akbari
Street address
Faculty of Dentistry Tehran University of Medical Sciences, North Kargar St. , Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹34
Phone
+98 21 4279 4000
Email
dentistry@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Sixth Floor Research and Technology, The central organization of the university, Qods St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Fax
+98 21 8898 9664
Email
vcr@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra jafari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Third floor, Yas Complex Block A1, Ahmadabadi St., Majdeh St., Hossein Abad Square., Tehran
City
Tehran
Province
Tehran
Postal code
1668843537
Phone
+98 21 2295 5981
Email
Nooriyalda106@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra jafari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Third floor, Yas Complex Block A1, Ahmadabadi St., Majdeh St., Hossein Abad Square., Tehran
City
Tehran
Province
Tehran
Postal code
1668843537
Phone
+98 21 2295 5981
Email
Nooriyalda106@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra jafari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Third floor, Yas Complex Block A1, Ahmadabadi St., Majdeh St., Hossein Abad Square., Tehran
City
Tehran
Province
Tehran
Postal code
1668843537
Phone
+98 21 2295 5981
Email
Nooriyalda106@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
I don't want to
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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