Comparison the effect of aromatherapy with lavender and Rosa damascena essential oils on stress, anxiety, depression and cortisol levels in hemodialysis patients
The aim of this study is to investigate the effect of aromatherapy on depression, anxiety and stress in hemodialysis patients .
Design: This study is a clinical trial involving three groups.Group 1 (lavender), Group 2 (Rose) and control.
Patients: A total of 90 participants were enrolled from 2 hemodialysis units at 2 hospitals (Shahid chamran and Baqiyatllah) in Tehran
Inclusion criteria: ability to read and write ; Hemodialysis three times a week ; Over three months of dialysis treatment ; Informed consent to participate in the study; Lack of stressful events in the last 6 months ; Lack of sedative drugs, or use other methods to reduce anxiety ; No problems in sense of smell
exclusion criteria : The problem occurred during the intervention ; absence of more than Three consecutive time ; Hospitalization for any reason
intervention: Stress, anxiety and depression are measured before and after intervention by using questionnaires DASS21 . Cortisol levels before and after intervention in all groups will be measured . Then the results will be compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013101314998N1
Registration date:2014-10-25, 1393/08/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-25, 1393/08/03
Registrant information
Name
Ali Tayebi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 105 8516
Email address
tayebi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nephrology Research Center of Baqiyatallah University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of aromatherapy with lavender and Rosa damascena essential oils on stress, anxiety, depression and cortisol levels in hemodialysis patients
Public title
Effect of aromatherapy on anxiety and depression in dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: ability to read and write ; Hemodialysis three times a week ; Over three months of dialysis treatment ; Informed consent to participate in the study; Lack of stressful events in the last 6 months ; Lack of sedative drugs, or use other methods to reduce anxiety ; No problems in sense of smell
exclusion criteria : The problem occurred during the intervention ; absence of more than Three consecutive time ; Hospitalization for any reason
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatqllah University of Medical Sciences
Street address
Mulla Sadra Street, Vanak Square, Tehran, Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
4
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
z49
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
DASS21
2
Description
Stress
Timepoint
Before and after intervention
Method of measurement
DASS21
3
Description
Depression
Timepoint
Before and after intervention
Method of measurement
DASS21
Secondary outcomes
1
Description
Cortisol levels
Timepoint
Before and after intervention
Method of measurement
Salivary cortisol testing
Intervention groups
1
Description
Three drops of lavender essential oil was poured on paper and The patients were asked to breathe normally The intervention duration was one hour
Category
Treatment - Other
2
Description
Three drops of Rose essential oil was poured on paper and The patients were asked to breathe normally The intervention duration was one hour
Category
Treatment - Other
3
Description
only Standard care in the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bagiyatallah hospital
Full name of responsible person
Ali Tayebi faculty member
Street address
Molla sadra Street , bagiyatallah hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Mr. Seif Head Nurse
Street address
Tehran ,Highway Sayyad Shirazi , Sanaye St. Shahid Chamran Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Einollahi
Street address
Mulla Sadra Street, Vanak Square, Tehran, Baqiyatallah University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Neuroscience Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Sahraei
Street address
Tehran; Nobonyad square , Araj Tee, Medical College , Baqhiyatallah University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neuroscience Research Center, Baqiyatallah University of Medical Sciences
Proportion provided by this source
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
Baqiyatallah University of Medical Sciences, nursing College
Full name of responsible person
Alireza Kasra Dehkordi
Position
Msc student of critical care nursing
Other areas of specialty/work
Street address
Tehran; Nobonyad square , Araj Tee, nursing college , Baqhiyatallah University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
alirezaparastar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Ali tayebi
Position
Master of Nursing Education
Other areas of specialty/work
Street address
Tehran; Nobonyad square , Araj Tee, nursing college , Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
tayebi@bmsu.ac.irtayybi.ali@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah university of Medical Sciences , college of nursing
Full name of responsible person
Alireza Kasra Dehkordi
Position
Msc student of critical care nursing
Other areas of specialty/work
Street address
tehran, Nobonyad square, Araj Tee, college of nursing - Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
alirezaparastar@gmail.coma_t_1344@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)