Overall purpose: Determining and comparing the effect of aromatherapy with music therapy on anxiety level of patients before inguinal herniorrhaphy
Design
The total number of specimens determined with the sample drop would be 141. After selecting the sample and obtaining patient satisfaction and ensuring the confidentiality of the information and introducing the questionnaires, the researcher will first assess the level of anxiety using the Spielberger Anxiety Inventory. After completing the questionnaires, the samples will be randomly assigned to three groups of aromatherapy with geranium extract and music therapy and control. Random allocation to three groups will be performed by patients by removing cards (a), (b) and (c).
Settings and conduct
This study will be a clinical trial. The research environment is Imam Khomeini Hospital in Mahabad. Participants who qualify for the study will complete a written consent form. This study will be single-blind, the researcher analyzing the statistical data will be unaware of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Satisfaction to participate in the study
No chronic anxiety
Ages over 18 and under 60 years
Intervention groups
The aromatherapy group for 30 minutes smells the extract of 50% aromatic geranium extract on a cotton ball that is attached to the patient's collar within 20 cm of the nose. The music therapy group will provide patients with a set of relaxing music that will be played by the headphones for 30 minutes. In the control group, there will be no intervention and they will rest in bed for half an hour.
Main outcome variables
Level of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131112015390N2
Registration date:2020-02-27, 1398/12/08
Registration timing:retrospective
Last update:2020-02-27, 1398/12/08
Update count:0
Registration date
2020-02-27, 1398/12/08
Registrant information
Name
Naser Parizad
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1348 7649
Email address
parizad.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
2019-08-07, 1398/05/16
Actual recruitment end date
2019-12-10, 1398/09/19
Trial completion date
2019-12-19, 1398/09/28
Scientific title
Comparing the effect of aromatherapy with music therapy on the patients anxiety level before inguinal herniorrhaphy
Public title
Comparing the effect of aromatherapy with music therapy on the patients anxiety level before inguinal herniorrhaphy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Ability to read and write
No history of hearing, olfactory or visual impairments
No mood disorders and lack of systemic diseases such as diabetes and cardiovascular disease
No pain relief, analgesic or anxiety medication such as inderal for more than a month, no pain
No history of thyroid disease and effective medications
No drug addiction
No history of inguinal hernia repair
No chronic anxiety (Spiel Berger questionnaire scores above 76 in open anxiety and 73 on hidden anxiety)
Not having allergies to geranium extract
Ages above 18 and under 60 years
Exclusion criteria:
Unwillingness to continue in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
141
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation to three groups will be performed by patients by removing cards (a), (b) and (c) and the researcher will be divided into three groups: music therapy, aromatherapy and control using cards (a), (b) and (c). Patients who were included in the study would then be admitted to the music therapy group, card (b) to the aromatherapy group, and card (c) to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be single-blind, so that, the researcher analyzing statistical data unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Resalet Boulevard, Emergency Cui
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-08-07, 1398/05/16
Ethics committee reference number
IR.UMSU.REC.1398.172
Health conditions studied
1
Description of health condition studied
Inguinal Hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Anxiety Scale in Spielberger's Hidden and Obvious Anxiety Scale Questionnaire: In this study, the effects of music therapy and aromatherapy on anxiety of patients before inguinal hernia surgery were evaluated. The researcher will first measure the level of anxiety by using the Spiel Berger Anxiety Inventory and latent anxiety questionnaire. After completing the questionnaires, the samples will be randomly assigned to three groups of aromatherapy with geranium extract and music therapy and control group.
Timepoint
Anxiety was measured before the intervention and then half an hour after the intervention
Method of measurement
Spielberger's Invisible and Hidden Anxiety Scale Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Music therapy Group; In the music therapy group, a collection of relaxing music previously produced by the researcher will be provided to patients, which will be played by the headphones for as long as 30 minutes. During this period, there will be no treatment other than music therapy for these patients.
Category
Behavior
2
Description
Intervention group: Aromatherapy Group with geranium aroma; In the aromatherapy group, ten drops of geranium extract of 50% aromatic geranium extract is dripped onto a cotton ball (2 to 2.5 cm in radius) and positioned by a collar to the patient's collar at a distance of 20 cm from the nose. The patient is asked to breathe normally for 30 minutes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Mahabad
Full name of responsible person
Naser Parizad
Street address
Sarbaz Street, Shahid Abdullah Pour Boulevard
City
Mahabad
Province
West Azarbaijan
Postal code
5915931637
Phone
+98 44 4222 6155
Email
parizad.n@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Street address
Resalet Boulevard, Emergency Cui
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
parizad.n@umsu.ac.ir
Grant name
School of Nursing and Midwifery, Urmia University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Pardis, 11th Km of the Seroo road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 1348 7649
Fax
+98 44 1275 4921
Email
parizad.n@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Pardis, 11th Km of the Seroo road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 1348 7649
Fax
+98 44 1275 4921
Email
parizad.n@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Pardis, 11th Km of the Seroo road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 1348 7649
Fax
+98 44 1275 4921
Email
parizad.n@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Data related to the main outcome of the study will be shared.
When the data will become available and for how long
Data access will begin three months after the results are published.
To whom data/document is available
All researchers and practitioners in the field can access the results.
Under which criteria data/document could be used
Anyone can access the results by pointing to the source used.
From where data/document is obtainable
People can access data from reputable databases that publish results.
What processes are involved for a request to access data/document
Searching for the main outcome of the research or the researchers conducting the research after publishing the results in valid databases