Comparison of the effect of traditional music with and without words on the level of anxiety of patients undergoing general surgery
Design
A controlled clinical trial, with parallel groups, randomized, on 102 surgical patients. Random blocking is used for randomization.
Settings and conduct
One of the non-pharmacological methods to reduce patients' anxiety is music. The study will be performed on patients who are candidates for general surgery. Samples will be divided into two intervention groups and one control group (34 patients in each group) based on random blocking. The intervention time is one hour before the surgery and the duration of the intervention is 15 minutes.
Traditional music with words and without words will be used for intervention groups. For the control group, headphones connected to the mute player will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria include general surgery candidate, willingness to participate in the study, 18 years and older, having pain and anxiety, interest in traditional music, no drug addiction, no thyroid diseases, no history of psychiatric illness, and a healthy sense of hearing.
Exclusion criteria include unwillingness to continue cooperation and receiving sedatives and narcotics during the intervention.
Intervention groups
The study groups consist of three groups: traditional music with words, traditional music without words, and control.
For the group of traditional music without words, the music of "Bidad" by Parviz Meshkatian will be played for 15 minutes.
In the traditional music group with words, the song "Ei Namat" by Alireza Eftekhari will be played for 15 minutes.
In the control group, headphones connected to the mute player will be used for 15 minutes.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100913004736N25
Registration date:2022-03-04, 1400/12/13
Registration timing:prospective
Last update:2022-03-04, 1400/12/13
Update count:0
Registration date
2022-03-04, 1400/12/13
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of traditional music with and without words on the level of anxiety of patients undergoing general surgery
Public title
The effect of music on the level of anxiety of patients undergoing surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
General surgery candidate
Having pain and anxiety
Willingness to participate in the study
A healthy sense of hearing
Interest in traditional music
Exclusion criteria:
Drug addiction
History of mental illness
Having thyroid diseases
Use of psychotropic drugs (anti-anxiety and anti-depressant drugs) from one week before the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be enrolled in the study using the convenience method and will be assigned to one of the groups of non-verbal traditional music, traditional verbal music, and control by random blocking method. Each block contains numbers from one to six. Each patient is assigned a number from one to six. Each group is assigned a letter (A to the non-verbal traditional music group, B to the traditional verbal music group, and C to the control group). A sequence is created for a sample size of 102 people. For the random allocation concealment process, 17 opaque envelopes and 102 cards will be prepared. Inside each envelope, six cards are placed in order. The number of blocks is written on each envelope. Patients are assigned to one of the study groups based on these letters. Random blocks will be generated by the statistics consultant. The process of randomly assigning patients to study groups will be performed by the researcher.
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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd.,
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.KUMS.REC.1400.804
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Pain
ICD-10 code
F45.4
ICD-10 code description
Pain disorders related to psychological factors
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
At the beginning of the study (before the intervention) and immediately after the intervention
Method of measurement
Spielberger Anxiety Questionnaire
Secondary outcomes
1
Description
Pain score according to Visual Analoge Scale
Timepoint
At the beginning of the study (before the intervention) and immediately after the intervention
Method of measurement
Visual Analoge Scale
Intervention groups
1
Description
Intervention group 1: In this group, traditional music without words will be played for 15 minutes. For this purpose, the music of "Bidad" by Parviz Meshkatian is played through headphones.
Category
Prevention
2
Description
Second intervention group: In this group, traditional music with words will be played for 15 minutes. For this purpose, the song "Ei Namat" by Alireza Eftekhari is played through headphones.
Category
Prevention
3
Description
Control group: In this group, headphones connected to a muted player will be used for 15 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Alireza Khatony
Street address
Nurse Blvd., Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Email
Akhatony@kums.ac.ir
2
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Alireza Khatony
Street address
Shahid Beheshti Blvd., Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
Akhatony@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Shahid Beheshti Blvd., Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3837 0541
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nurse Blvd., Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Email
Akhatony@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nurse Blvd., Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Email
Akhatony@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nurse Blvd., Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
+98 83 3827 9394
Email
akhatony@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available