Protocol summary

Summary
This study aims to examine the effects of aromatherapy with lavender on the quality of sleep among the nursing student. This research is a Single blind clinical trial conducted on 60 of first and second semester nursing students of Arak University. Participants were randomly categorized into two groups of intervention and control. In intervention group were asked to apply 2gtt lavender essential oil on a piece of cotton wool and place it at a distance of 20 cm for 7 nights a week. distilled water were used as placebos in control groups.The study was blinded for groups. Pittsburgh Sleep Quality Index (PSQI) was used for data gathering and Sleep Quality was administered to both groups before and after aromatherapy

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014062814340N2
Registration date: 2014-08-02, 1393/05/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-02, 1393/05/11
Registrant information
Name
Soheila Shamsikhani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
shamsikhani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences.
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-07-17, 1392/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey Effect of aromatherapy with lavender on the quality of sleep in Nursing students
Public title
Effect of aromatherapy with lavender oil on the quality of sleep
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: females ; Not living in Dormitory;No known psychiatric & physical disorders ;No consumption of Sleep medication, anti depression ;No history of migraine headaches;No known history of asthma and allergies Exclusion criteria:Participants were excluded if they experienced crisis or unforeseen event during the study
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ehics commitee of Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Postal code
Iran
Approval date
2012-07-02, 1391/04/12
Ethics committee reference number
14-128-91

Health conditions studied

1

Description of health condition studied
quality of sleep
ICD-10 code
G47.8
ICD-10 code description
Other sleep disorders

Primary outcomes

1

Description
sleep quality
Timepoint
Before the intervention and a week after intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Two drops of lavender essential oil prepared on non-absorbent paper and be kept for 20 minutes at a distance of 20 cm Front nose with deep breathing , the procedure repeated for 7 night
Category
Other

2

Description
Two drops of Distilled water prepared on non-absorbent paper and be kept for 20 minutes at a distance of 20 cm Front nose with deep breathing , the procedure repeated for 7 night
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nursing of Arak University of Medical Sciences
Full name of responsible person
Soheila Shamsikhani
Street address
Saradasht
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences.
Full name of responsible person
Dr. Said Changizi Ashtiyani
Street address
Arak University of Mdical Sciences, Sardasht
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Soheila Shamsikhani
Position
MSc Nursing/Faculty Member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Sardasht st
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
shamsikhani@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak university of Medical Siences
Full name of responsible person
Soheila Shamsikhani
Position
MSc Nursing/Faculty Member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Sardasht st
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
shamsikhani@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Soheila Shamsikhani
Position
MSc Nursing/Faculty Member
Other areas of specialty/work
Street address
Sardasht
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
shamsikhani@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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