Comparison of the effects of aroma Inhalation and essential oil massage of lavender and sweet orange on quality of life, anxiety and pain in women with breast cancer
Comparison of the effects of aroma Inhalation and essential oil massage of lavender and sweet orange on quality of life, anxiety and pain in women with breast cancer
Design
This study is an experimental study of clinical trial with control group and is single blind. Simple randomized, the sample size is 50 patients; one group is essential oil inhalation and the other group is aromatic massage.
Settings and conduct
There is one intervention group of combined inhalation of lavender and sweet orange essential oil and the other group of intervention intervention combines both aromas. Each intervention is performed every day for 15 minutes for two weeks. Location of study in the oncology ward of the hospital,in a private room at the end of the ward, while obtaining permission from the relevant authorities.The control group was selected from patients who did not want to participate in the study and receive only routine care. Study is single blind and the samples do not know how to assign it to the intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: according to the Spielberger questionnaire test, they had mild, moderate and severe anxiety; willing to participate in the study; Having a medical record for confirmation of a diagnosis of breast cancer by a specialist; Exclusion criteria: History of respiratory , diabetes, liver and kidney diseases; Drug addiction.
Intervention groups
One group inhaled the scent of essential oil and the other group the intervention of the scent massage
Main outcome variables
To improve the quality of life; To reduce pain; To reduce anxiety in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150302021298N3
Registration date:2020-08-21, 1399/05/31
Registration timing:prospective
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Sanaz Bostani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
sanaz.bostani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-23, 1399/06/02
Expected recruitment end date
2020-09-23, 1399/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of aroma Inhalation and essential oil massage of lavender and sweet orange on quality of life, anxiety and pain in women with breast cancer
Public title
Comparison of the effect of Inhalation and essential oil massage of lavender and sweet orange on quality of life, anxiety and pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
According to the Spielberger questionnaire test, they had mild, moderate and severe anxiety
Breast cancer confirmed by oncologist
Healthy sense of smelling
Exclusion criteria:
Amputation of one or both legs
Drug addiction
History of respiratory, diabetes, heart, liver and kidney diseases
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind: only participants are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Iran, Hormozgan, Bandar Abbas, at the beginning of Imam Hossein Boulevard, in front of Kargaran Sports Club, next to Nabout Town - School of Nursing and Midwifery
City
BandarAbbas
Province
Hormozgan
Postal code
076-3317723
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.HUMS.REC.1399.152
Health conditions studied
1
Description of health condition studied
Pain, anxiety and quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Spielberger's questionnaire
Timepoint
Before and two weeks after the start of the intervention
Method of measurement
Spielberger trait anxiety inventory
2
Description
Pain
Timepoint
Before and two weeks after the intervention
Method of measurement
The brief pain inventory
3
Description
Quality of life
Timepoint
Before and two weeks after the intervention
Method of measurement
Based on standard quality of life questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: includes the use of aroma by inhalation. How to do it: Pour two drops of lavender essential oil with sweet orange (Production of Mehrgol Broadcasting company) in a ratio of 1: 1 on a 2-by-2 gas dropper; The patient was then asked to breathe normally for 20-20 minutes. This will be done every day for 2 weeks.
Category
Rehabilitation
2
Description
Intervention group 2: Using aroma as a massage, inhale two drops of lavender essential oil with sweet orange (Production of Mehrgol Broadcasting company) in a ratio of 1: 1 and the next group mix lavender essential oil with sweet orange in a ratio of 1: 1, which has been diluted by 3% using sweet almond oil. 5 cc is used to massage the toes, soles of the feet to the ankles.
Category
Rehabilitation
3
Description
Control group: People who do not want to participate in the study will be selected; This group receives only routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital and Persian Gulf Bandar Abbas and Omid Cancer Center
Full name of responsible person
Sanaz Bostani
Street address
Iran, Hormozgan, Bandar Abbas, at the beginning of Imam Hossein Boulevard, in front of Kargaran Sports Club, next to Nabout Town - School of Nursing and Midwifery
City
BandarAbbas
Province
Hormozgan
Postal code
076-3317723
Phone
+98 76 3331 7723
Email
sanaz.bostani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sanaz Bostani
Street address
Iran, Hormozgan, Bandar Abbas, at the beginning of Imam Hossein Boulevard, in front of Kargaran Sports Club, next to Nabout Town - School of Nursing and Midwifery
City
BandarAbbas
Province
Hormozgan
Postal code
:076-3317723
Phone
+98 76 3331 7723
Email
sanaz.bostani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sanaz Bostani
Position
Totur
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran, Hormozgan, Bandar Abbas, at the beginning of Imam Hossein Boulevard, in front of Kargaran Sports Club, next to Nabout Town - School of Nursing and Midwifery
City
BandarAbbas
Province
Hormozgan
Postal code
076-3317723
Phone
+98 76 3331 7723
Email
sanaz.bostani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sanaz Bostani
Position
Totur
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran, Hormozgan, Bandar Abbas, At the beginning of Imam Hossein boulevard, In front of Kargaran sports club, Next to Nabovat town - School of nursing and midwifery
City
BandarAbbas
Province
Hormozgan
Postal code
076-3317723
Phone
+98 76 3331 7723
Email
sanaz.bostani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sanaz Bostani
Position
Totur
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran, Hormozgan, Bandar Abbas, at the beginning of Imam Hossein Boulevard, in front of Kargaran Sports Club, next to Nabout Town - School of Nursing and Midwifery
City
BandarAbbas
Province
Hormozgan
Postal code
076-3317723
Phone
+98 76 3331 7723
Email
sanaz.bostani@gmail.com
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available