Comparison of the effect of aromatherapy and music on the level of anxiety and vital signs of patients undergoing ESWL
Design
Eligible patients participating in the study are readily available and randomly assigned to one of the intervention groups (music, aromatherapy, music composition and aromatherapy) and control. The sample size is 176 people.
Settings and conduct
Eligible patients participating in the study are readily available and randomly assigned to one of the intervention groups (music, aromatherapy, music composition and aromatherapy) and control.
Participants/Inclusion and exclusion criteria
The participants in this study are all patients with kidney stones and urinary tract patients who refer to the ESWL unit. Criteria for entering the study include: willingness to participate in the study, having a minimum age of 18 and a maximum age of 65, literate and able to communicate and communicate effectively, no allergies or respiratory diseases, having a healthy sense of smell and hearing, not using hearing aids, no previous history of ESWL, no high blood pressure, no treatment with antihypertensive drugs, no diseases associated with high blood pressure. Criteria for withdrawal from the study include receiving drugs and anti-anxiety drugs during the study and the impossibility of continuing the patient's participation in the study for any reason.
Intervention groups
Aromatherapy - Music Therapy - Combination - Control
Main outcome variables
Anxiety and vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100913004736N23
Registration date:2020-11-07, 1399/08/17
Registration timing:registered_while_recruiting
Last update:2020-11-07, 1399/08/17
Update count:0
Registration date
2020-11-07, 1399/08/17
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
2020-11-05, 1399/08/15
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of inhalation aromatherapy and music on anxiety and vital signs of patients under extracorporeal shock wave lithotripsy
Public title
The effect of aromatherapy and music on the anxiety and vital signs of patients undergoing lithotripsy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age 18 to 65 years
Literate
Stability of vital signs
Healthy sense of smell
Healthy sense of hearing
Exclusion criteria:
Previous history of lithotripsy
drug addiction
consumption of psychoactive drugs
Any kind of allergy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
First, a random block of 8 will be created using the website https://www.sealedenvelope.com.
Regarding the implementation of the random allocation process, the following are considered:
A) Blocks of 8 are considered.
B) One letter is assigned to each group: A to the band, B to the aromatherapy, C to the combination of music and aromatherapy, and D to none of the interventions (control group)
C) A sequence of letters will be created for a sample size of 200.
D) For the random allocation concealment process, 25 opaque envelopes and 200 cards will be created. Inside each envelope, eight cards are placed in sequence.
The number of blocks is written on each envelope. On each card, the name of the desired group will be written in sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person collecting sample information and controlling their vital signs, as well as the data analyst, are unaware of assigning samples to study groups.
Placebo
Used
Assignment
Factorial
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 Behesht BLVD.,
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
IR.KUMS.REC.1399.651
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy
Method of measurement
Spielberger Anxiety Questionnaire
2
Description
Blood pressure
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy
Method of measurement
Mercury sphygmomanometer
3
Description
Temperature
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy
Method of measurement
Tympanic thermometer
4
Description
Heart Rate
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy
Method of measurement
Counting the number of radial pulse in one minute
5
Description
Respiratory rate
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the lithotripsy
Method of measurement
Counting the number of breaths in one minute
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group (music group): In this group, during the lithotripsy, traditional Iranian music is played through headphones.
Category
Prevention
2
Description
The second intervention group (aromatherapy group): In this group, during the lithotripsy, aromatherapy is performed with three drops of 25% Rose Damascena essential oil.
Category
Prevention
3
Description
Third intervention group (music and aromatherapy group): In this group, a combination of traditional Iranian music and aromatherapy with three drops of 25% Rose Damascena essential oil is used.
Category
Prevention
4
Description
Control group: There is no intervention in this group
Category
Placebo
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shahid Beheshti Blvd., Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3837 0541
Email
farid_n32@yahoo.com
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