Comparison of the effect of music therapy and aromatherapy on anxiety and physiological parameters of patients undergoing surgery
Design
Randomized control clinical trial, Parallel design, Single-blind and on 92 patients. Random blocking is used for randomization.
Settings and conduct
The study is performed on surgical patients admitted to the intensive care unit. In the music therapy group, traditional non-verbal music is played to patients through headphones for half an hour. In the aromatherapy group, 25% rosemary essential oil is used by inhalation for half an hour. For the combined group, traditional music without words, and aromatherapy with 25% rosemary essential oil are performed simultaneously for half an hour.
In the control group, silent headphones and aromatherapy with aromatic distilled water (a combination of distilled water and a very small amount of 25% of rosemary essential oil) are used. Blinding is done only for the statistician and he will not be informed of the names of the groups until the analysis is completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in the study, healthy hearing
Exclusion criteria: Patient request
Intervention groups
Study groups include music therapy, aromatherapy, combination of music therapy and aromatherapy, and control.
Main outcome variables
Anxiety, Physiological indexes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100913004736N27
Registration date:2022-06-02, 1401/03/12
Registration timing:prospective
Last update:2022-06-02, 1401/03/12
Update count:0
Registration date
2022-06-02, 1401/03/12
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
2022-07-23, 1401/05/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of music therapy and aromatherapy on anxiety and physiological parameters of patients undergoing surgery
Public title
The effect of music therapy and aromatherapy on anxiety and physiological parameters
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
No history of allergies
Age over 18 years and under 65 years
level of consciousness 15 based on the Glasgow Coma Scale
Healthy sense of hearing
Not having thyroid disease
No drug addiction
No psychiatric illness
Exclusion criteria:
Patient request to leave the study
Changing the level of consciousness
Transferring the patient to another ward
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are admitted to the study by convenience methods and randomly assigned to one of the study groups based on random blocking. Random sequences will be generated online through sealed www.envelope.com.
Study groups include music therapy (A), aromatherapy (B), combination of music therapy and aromatherapy (C), and control (D).
For the allocation concealment, 12 opaque envelopes and 92 cards will be prepared. Inside each envelope, 8 cards are placed. The number of blocks is written on each envelope. Abbreviation code (A, B, C and D) of each group is written on each card. Patients are placed in one of the study groups based on the codes on each card. This process is performed by the researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single-blind, and the statistician is unaware of the equivalence of each code for each group from the beginning, and this ignorance will continue until the end of the data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Arak University of Medical Sciences
Street address
Pasteur Street
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.ARAKMU.REC.1401.032
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
Physiological indicators
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety Score in Spielberger Questionnaire
Timepoint
Before and after the intervention
Method of measurement
Spielberger Questionnaire
2
Description
Heart rate per minute
Timepoint
Before and after the intervention
Method of measurement
The value on the monitor
3
Description
Percentage of oxygen saturation
Timepoint
Before and after the intervention
Method of measurement
The value on the monitor
4
Description
Temperature
Timepoint
Before and after the intervention
Method of measurement
The value on the monitor
5
Description
Blood pressure
Timepoint
Before and after the intervention
Method of measurement
The value on the monitor
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the music group, non-verbal music is played through headphones for 30 minutes.
Category
Prevention
2
Description
Second intervention group: In the aromatherapy group, three drops of 25% rosemary essential oil are poured on a piece of cotton ball and attached to the patient's collar. The patient is asked to breathe normally for 30 minutes.
Category
Prevention
3
Description
Third intervention group: In this group, a combination of aromatherapy and music therapy is used. For this purpose, similar to the aromatherapy group, 25% rosemary essential oil is used for 30 minutes. Simultaneously with aromatherapy, non-verbal music is played to patients through headphones for 30 minutes.
Category
Prevention
4
Description
In this group, headphones without sound playback, and aromatherapy with aromatic distilled water are used simultaneously. For aromatherapy, a very small amount (in micrograms) of 25% rosemary essential oil is added to distilled water and acts similarly to the aromatherapy group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatolah Taleghani hospital
Full name of responsible person
Alireza Khatony
Street address
ُShahid Beheshti Blvd.,
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
Akhatony@kums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Alireza Khatony
Street address
Parastar Blvd.,
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3427 6301
Email
Akhatony@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij square, University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3532
Email
Alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Parastar Blvd, Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3427 6301
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
Parastar Blvd., Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3427 6301
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
Parastar Blvd., Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3427 6301
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