(1)Objectives: The aim of this study is determine the effect of inhalation of lavender essential oil on sleep quality in patients undergoing hemodialysis. (2)Design: The study population included patients undergoing hemodialysis. The study will be done in a group of 53 patients without controls group, without blinding and randomization and in a single dialysis center in Valiasr hospital in Arak city for 4 weeks. (3)Setting and conduct: This quasi-experimental study will be conducted before and after a group. Patients will be selected based on purposive sampling and written consent of the samples will be collected for the study. Researcher will check sleep quality of patients by using of Pittsburgh Sleep Quality Index and a weekly sleep diary. (4) Inclusion criteria: having sleep quality score over of 5 based on Pittsburgh index; no history of asthma and allergies to flowers and plants; no history of olfactory dysfunction. Exclusion criteria: If occur a crisis or an unforeseen event for patients during the intervention period. (5)Intervention: Patients are taught how to use of inhalation of lavender essential oil by cotton ball soaked in 2 drops of pure essential oil at a distance of 20-15 cm of pillow will be placed and then will be asked of them to do this work for 3 times in a week for a night in between before bedtime for 4 weeks. (5)Main outcome measures: After 4 weeks, sleep quality of samples will be tested again and sleep quality survey results will be compared before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061622774N1
Registration date:2015-09-20, 1394/06/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-20, 1394/06/29
Registrant information
Name
Maryam Sadeghi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 863313605558
Email address
m.sadeghi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-10-06, 1391/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on sleep quality in hemodialysis patients
Public title
The effect of lavender aromatherapy on sleep quality in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having the age of minimum 18 and maximum 65 years; no history of asthma and allergies to flowers and plants; Agreement for attending in the study; experience of at least 6 months of hemodialysis; no history of olfactory dysfunction; having sleep quality score over of 5 based on Pittsburgh index; Complementary medicine treatment methods (Herbal methods and other Methods) are not used in the last week; Do not use sleeping medications, sedatives; No drug addiction; No dialysis in the night shift; Not suffering from known mental illness; Being consciousness and acceptable ability of listening and speaking to answer questions and learn using of lavender essential oil. Exclusion criteria: no agreement for attending in the study; If occur a crisis or an unforeseen event for patients during the intervention period; If the patient didn’t complete weekly sheet of sleep records. (Patients should record at least 21 days of sleeps them in sheet notes, otherwise they will exclude of study).
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
53
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services
Street address
Shahid Chamran Highway-Yemen Street-Shahid Arabi street- Next Ayatollah Taleghani hospital- Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-09-30, 1391/07/09
Ethics committee reference number
9018685681
Health conditions studied
1
Description of health condition studied
sleep disorders in hemodialysis patients
ICD-10 code
N18.9
ICD-10 code description
Chronic renal failure, unspecified
Primary outcomes
1
Description
sleep quality
Timepoint
After 4 weeks of intervention
Method of measurement
Pittsburgh Sleep Quality Index and weekly sheet of sleep record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention including inhalation of lavender essential oil by cotton ball soaked in 2 drops of pure essential oil ( made by Barij Essence Pharmaceutical Company of Kashan) at a distance of 20-15 cm of pillow will be placed and then do this work for 3 times in a week for a night in between before bedtime for 4 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis ward of Vali-e-Asr hospital affiliated with Arak University of Medical Sciences
Full name of responsible person
Maryam Sadeghi
Street address
Vali-e-Asr Sq,Vali-e-Asr Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Maryam Sadeghi
Street address
Vali-e-Asr sq,Vali-e-Asr Hospital
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Nursing and Midwifery school of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Aazam Dabirian
Position
Ms Degree in Nursing Education
Other areas of specialty/work
Street address
Vali-e-Asr Street,Crossing Niayesh ,Against Shahid Rajaei Hospital, Nursing and Midwifery school of Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
AazamDabirian@yahoo.comAazamDabirian@sbmu.ac.ir ,
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Mojab
Position
Pharmacy PHD, Assistant Professor
Other areas of specialty/work
Street address
Vali-e-Asr Street,Near the Crossing Niayesh ,School of Pharmacy of Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
1991953381
Phone
+98 86 8820 0118
Fax
Email
sfmojab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Sadeghi
Position
Ms Degree in Nursing Education
Other areas of specialty/work
Street address
Shahid Shirudi Street,Alam-Al-Hoda Street, Arak University of Medical Sciences