Comparison of the effect of aromatherapy with roses and music therapy versus control group on anxiety level of patients who are candidate for elective general surgery: a randomized clinical trial
Objectives: To compare the effect of aromatherapy with roses and music therapy versus control group on anxiety level of patients before elective general surgery
Design: A randomized clinical trial.
Setting and conduct: The eligible patients who are candidate for elective general surgery will refer to Kosar Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 54 years; candidate for elective general surgery; mental, verbal, visual, hearing and olfactory ability
Exclusion criteria: Anxiety score more than 8 based on Beck anxiety test; cancer; receiving psychotropic, opioid, analgesic and sedative drugs; having pain before surgery, a history of allergy, asthma or allergic rhinitis
Intervention group 1: Routine care plus playing instrumental music through headphone for 20 min.
Intervention group 2: Routine care plus aromatherapy with roses for 10 min.
Control group: Just routine care.
Primary outcome: Assessing the anxiety level before and 30 min after intervention using standard Beck anxiety questionnaire.
RandomizationThe patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706089014N169
Registration date:2017-06-09, 1396/03/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-09, 1396/03/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of aromatherapy with roses and music therapy versus control group on anxiety level of patients who are candidate for elective general surgery: a randomized clinical trial
Public title
Comparison of the effect of aromatherapy with roses and music therapy versus control group on anxiety level of patients who are candidate for elective general surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 54 years; candidate for elective general surgery; mental, verbal, visual, hearing and olfactory ability
Exclusion criteria: Anxiety score more than 8 based on Beck anxiety test; cancer; receiving psychotropic, opioid, analgesic and sedative drugs; having pain before surgery, a history of allergy, asthma or allergic rhinitis
Age
From 18 years old to 54 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
RandomizationThe patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Postal code
Approval date
2017-05-20, 1396/02/30
Ethics committee reference number
IR.SUMS.REC.1396.28
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Assessing the anxiety level
Timepoint
before and 30 min after intervention
Method of measurement
using standard Beck anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Routine care plus playing instrumental music through headphone for 20 min.
Category
Other
2
Description
Intervention group 2: Routine care plus aromatherapy with roses for 10 min.
Category
Treatment - Drugs
3
Description
Control group: Just routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Hashem Rahmati
Street address
Kosar Hospital, Daneshgah Ave.
City
Sanadaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Shiraz University of Medical Sciences
Full name of responsible person
Hashem Rahmati
Street address
Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Hashem Rahmati
Position
MSc in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71 3230 5410
Fax
Email
H-Ramati1076@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Hashem Rahmati
Position
MSc in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71 3230 5410
Fax
Email
H-Ramati1076@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)