Objective: This study is designed aimed to determine the effects of lavender aromatherapy on sleep quality in pregnant women in the third trimester. This study is an intervention study and design for the two groups (exam and control group) with two per-test and post-test. Community formation pregnant women referred to the center of physiologic delivery Fatemieh hospital in Hamadan .A sample of 36 patients in the intervention group and 36 patients in the control group has been set. After completing the Pittsburgh questionnaire via primary pregnant women who have entered the third trimester (from week 29 of pregnancy) and Determine People who have score high 5 on the questionnaire Pittsburgh and Inclusion criteria are having, 72 people randomly placed into two groups: control and test. Mothers in the intervention group to be delivered Lavender essential oil produced from Barij Esanse. For a month, four days a week at night before going to bed two drops of the contents of the glass on a clean cloth or cotton fabric and With a distance of 20 cm from the nose, 10 deep breath and beside your pillow until the morning. In weeks 2 and 4 after intervention by individuals in the experimental group and Control group completed questionnaires Pittsburg .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061710426N11
Registration date:2016-06-28, 1395/04/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-28, 1395/04/08
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-07-01, 1395/04/11
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect aromatherapy with lavender on sleep quality third trimester pregnant women
Public title
The effect aromatherapy with lavender on sleep quality third trimester pregnant women referred to Fatemieh hospital in Hamadan in 2016
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age ranged between 18-35 years; primi- gravid; lack of lavender mother's insensitivity; lack of physical and mental illness in the mother; lack of stress and domestic violence against the mother; the absence of high-risk pregnancy symptoms in the mother;
No history of allergic rhinitis; eczema or breathing problems such as asthma ;lack of drug addiction.
Exclusion criteria:The incidence of allergy symptoms in the mother, lavender inhaled less than four times a week.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences- Shahid Fahmideh Street- Counterpoint of Mardom Park- Hamadan
City
Hamadan
Postal code
65178
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.UMSHA.REC.1395.33
Health conditions studied
1
Description of health condition studied
Aromatherapy with lavender on sleep quality in pregnancy; Pregnancy-related condition, unspecified
ICD-10 code
O26.9
ICD-10 code description
Pregnancy-related condition, unspecified
Primary outcomes
1
Description
sleep quality
Timepoint
before, two weeks after intervention-four weeks after intervention
Method of measurement
Standard Pittsburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: After obtaining written testimonial from samples, People who score high of 5 in the questionnaire, Coincidentally divided with the lottery with a coin into one of two groups of experimental group and the control group. Mothers in the intervention group to be delivered Lavender essential oil produced from Barij Esanse. Mothers will ask for a a month, four days a week at night before going to bed two drops of the placebo contents put in a clean cloth or cotton fabric and inhale it with a distance of 20 cm from their nose. After 10 deep breath, put it beside pillow until the morning. After 2 and 4 weeks control group will complete the Pittsburgh questionnaires .
Category
Treatment - Drugs
2
Description
Control : . Mothers in the control group to be delivered placebo (water) in a bottle as same as intervention group.Mothers will ask for a a month, four days a week at night before going to bed two drops of the placebo contents put in a clean cloth or cotton fabric and inhale it with a distance of 20 cm from their nose. After 10 deep breath, put it beside pillow until the morning. After 2 and 4 weeks control group will complete the Pittsburgh questionnaires .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemih Hospital
Full name of responsible person
Fahimeh Ezati Arasteh
Street address
Shahid Zamani, Fatemih Hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saied Bashirian
Street address
Shahid Fahmideh Street, Counterpoint of Mardom ParkHamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street, Counterpont of Mardom Park, Hamadan
City
Hamadan
Postal code
Phone
+98 65 1783 8698
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)