The purpose of this study is to determine the effect of aromatherapy with lavender essence on anxiety, depression and fatigue in patients undergoing hemodialysis Patient including major criteria: at least 6 months of dialysis treatment; dialysis for 3 times a week; being over 18 years; alertness and ability to communicate; having a good sense of smell; have not a stressful event in the past 6 months; don't using sedatives drugs. Patient eligibility major criteria: candidate for a transplant; pregnancy or decision to pregnancy; record of allergies; chronic respiratory diseases; addiction At the baseline demographic and clinical data will be collected using check list and questionnaires. Fatigue severity will be measured using Fatigue Severity Scale. Assessment of anxiety and depression in patients will be done with hospital anxiety and depression questionnaire. Well being will be measured using VAS scale. Experimental group: experimental group will be exposed to the inhalation of lavender essence produced by Barij certified pharmaceutical company with quality standards of ISO 9001 and ISO / IEC 17025 . Lavender essence is produced from fresh flowering parts of the plant which contains Linalool, Linalool acetate, Caffeic acid and Tannins. Since pure lavender essence is highly concentrated and its use irritates the patients, the essence is diluted with sweet almond oil. In experimental group a cotton ball soaked with 2 drops of lavender essential oil with concentrations of 10% in the first week (3 first session), 20% in the second week (3 second session ), 30% in the third week (3 third session), 40% in the week fourth (3 fourth session) and 50% in the fifth week (3 fifth sessions ) attached to his collar and he will be asked to breathe normally for 20 minutes.: Patients in the control group will be received usual care.anxiety, depression ,fatigue and well being questionnaire will be complete in the end of each week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505257494N12
Registration date:2015-12-10, 1394/09/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-10, 1394/09/19
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Mazandaran University of Medical Sciences.
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with lavender Essential oil on anxiety, depression and fatigue, in hemodialysis patients
Public title
Effect of lavender on anxiety, depression and fatigue in hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Patient including major criteria: at least 6 months of dialysis treatment; dialysis for 3 times a week; being over 18 years; alertness and ability to communicate; having a good sense of smell; have not a stressful event in the past 6 months; don't using sedatives drugs Patient eligibility major criteria: candidate for a transplant; pregnancy or decision to pregnancy; record of allergies; chronic respiratory diseases; addiction
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Science
Street address
Moalem Street, Moalem Square, Sari
City
Sari
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.MAZUMS.REC.94
Health conditions studied
1
Description of health condition studied
hemodialysis patient
ICD-10 code
Z49.0
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
depression and anxiety
Timepoint
Before intervention first week, second week,third week, fourth week and fifth week
Method of measurement
Hospital Anxiety and Depression Scale
2
Description
fatigue
Timepoint
Before intervention first week, second week,third week, fourth week and fifth week
Method of measurement
Fatigue Severity Scale
3
Description
well being
Timepoint
Before intervention first week, second week,third week, fourth week and fifth week
Method of measurement
visula Analogue scale
Secondary outcomes
1
Description
Allergic to Lavender
Timepoint
During five weeks of intervention
Method of measurement
Questions from Patients
Intervention groups
1
Description
experimental group will be exposed to the inhalation of lavender essence produced by Barij certified pharmaceutical company with quality standards of ISO 9001 and ISO / IEC 17025. Lavender essence is produced from fresh flowering parts of the plant which contains Linalool, Linalool acetate, Caffeic acid and Tannins. Since pure lavender essence is highly concentrated and its use irritates the patients, the essence is diluted with sweet almond oil. In experimental group a cotton ball soaked with 2 drops of lavender essential oil with concentrations of 10% in the first week (3 first session), 20% in the second week (3 second session ), 30% in the third week (3 third session), 40% in the week fourth (3 fourth session) and 50% in the fifth week (3 fifth sessions ) attached to his collar and he will be asked to breathe normally for 20 minutes
Category
Treatment - Drugs
2
Description
Patients in the control group will be received usual care
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Behshahe Hospital
Full name of responsible person
Ali Mahdavi
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Attieh Nikkhah
Position
MSC in Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran.
City
Sari
Postal code
4815696869
Phone
+98 11 3337 1010
Fax
Email
atinik1357@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
Associate Professor
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical, Sciences, Sari, Iran.
City
Sari
Postal code
Phone
+98 11 3336 7345
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)