The aim of this study was to investigate the effect of Rose Rhythm on anxiety and third-grade sleep quality in pregnant women. This randomized, non-coded, randomized, double-blind, control group (62) and control (62 people) clinical trials. The research samples will be divided into randomly assigned cluster sampling centers for all intervention centers and control B centers, based on all the health centers of the urban community. The statistical information questionnaire of Espilogger and Petersberg will be filled in by samples. Then, the essential oil of Mohammad's flower will be given to the test group to put 3 drops on a cloth for 2 weeks each night before bedtime and put them on the pillow to expose the perfume during the night to the inhalation. In the control group, only the usual care of the pregnancy will be done by the mother's regular visit to the clinic.
General information
Acronym
Aromatherapy in pregnancy
IRCT registration information
IRCT registration number:IRCT2017052134063N1
Registration date:2017-10-03, 1396/07/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Azita moharamkhani
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan)
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4001
Email address
a.moharamkhani@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Isfahan (Khorasgan)
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2017-12-11, 1396/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of of Roses (Rosa damascena) Aroma on the anxiety and quality of sleep in the third trimester in pregnant women
Public title
The effect of of Roses (Rosa damascena) Aroma on anxiety and sleep quality in the third trimester of pregnant women in Abhar city clinic in 2016
Purpose
Treatment
Inclusion/Exclusion criteria
The age range of 18-35 years of single-pregnancy
Gestational age 38-28
Having a healthy pregnancy
At least the reading and writing skills
Insensitivity to Golmohammadi Essential Oil
Not having an inhaled problem Do not have respiratory illnesses like asthma and allergies
Not having a history of nasal and nasal polyposis
Do not use any hypnotics or anxiety drugs
Exit terms:
Unwillingness to cooperate
The occurrence of any problem in pregnancy is considered during the study of non-regular intervention for one third of the time
Use of sleep medications and anxiety
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:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Preparation of Roses (Rosa damascena) Designed for This Study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Najaf Abad University
Street address
Iran, Isfahan, Najaf Abad, University Blvd, Islamic Azad University, Najaf Abad
City
Isfahan
Postal code
00983142292929
Approval date
2017-04-20, 1396/01/31
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1396.29
Health conditions studied
1
Description of health condition studied
Anxiety and quality of sleep in the third trimester of pregnant women
ICD-10 code
O20-O29
ICD-10 code description
O20-O29
Primary outcomes
1
Description
anxiety and sleep quality in the third trimester of pregnant women
Timepoint
XV Pregnancy, childbirth and the puerperium
Method of measurement
XV Pregnancy, childbirth and the puerperium
2
Description
sleep quality
Timepoint
14 days
Method of measurement
Petersberg Questionnaire
Secondary outcomes
1
Description
sleep quality
Timepoint
14 days
Method of measurement
Petersberg Questionnaire
2
Description
Anxiety
Timepoint
14 days
Method of measurement
Spiel Berger questionnaire
Intervention groups
1
Description
The intervention group, along with the usual pregnancy care at the center of the city community, also receive a floral scent from Mohammadi. In this way, for 14 days, every 3 o'clock, drops of a flower extract are placed on a cotton cloth and put on their own pillows to expose the fragrance during the night.
Category
Treatment - Drugs
2
Description
The control group receives only the care of the current pregnancy period of the community health center without intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic No. 5
Full name of responsible person
Azita moharamkhani
Street address
First of 17 shahrinar street
City
Abbhar
2
Recruitment center
Name of recruitment center
Clinic No. 6
Full name of responsible person
Azita moharamkhani
Street address
Moalem Square
City
Abbhar
3
Recruitment center
Name of recruitment center
Clinic No. 8
Full name of responsible person
Azita moharamkhani
Street address
Hussein Abad - the end of Mousavi Street
City
Abbhar
4
Recruitment center
Name of recruitment center
Clinic No. 1
Full name of responsible person
Azita moharamkhani
Street address
Dr. Beheshti Avenue
City
Abbhar
5
Recruitment center
Name of recruitment center
Clinic No. 2
Full name of responsible person
Azita moharamkhani
Street address
Dr. Beheshti Avenue - Fayyaz Branch Alley
City
Abbhar
6
Recruitment center
Name of recruitment center
Clinic No. 3
Full name of responsible person
Azita moharamkhani
Street address
Beheshti Avenue - Tohid Square
City
Abbhar
7
Recruitment center
Name of recruitment center
Clinic No. 4
Full name of responsible person
Khodagoli
Street address
17 shahrivar Street
City
Abbhar
8
Recruitment center
Name of recruitment center
Clinic No. 7
Full name of responsible person
Sahar Nassiri
Street address
Abhar - Shahid Beheshti - Alley of Benesh
City
Abbhar
9
Recruitment center
Name of recruitment center
Clinic No. 9
Full name of responsible person
Jafari
Street address
Valiasr Streetr -Varzesh square
City
Abbhar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
forozandeh dashti
Street address
Isfahan- East Azarbayjan-Arghavaniyeh- University Blvd- Faculty of Nursing and Midwifery
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Isfahan (Khorasgan)
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
Isfahan University of Khorasgan Branch
Full name of responsible person
Azita moharamkhani
Position
Master of Nursing
Other areas of specialty/work
Street address
Isfahan- East Azarbayjan-Arghavaniyeh- University Blvd.
City
Isfahan
Postal code
8155139998
Phone
+98 31 3535 4001
Fax
Email
moharamkhani27@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
forozandeh dashti
Position
Midwifery student
Other areas of specialty/work
Street address
Isfahan- East Azarbayjan-Arghavaniyeh- University Blvd- Faculty of Nursing and Midwifery
City
Isfahan
Postal code
8155139998
Phone
+98 31 3535 4001
Fax
Email
Dashti@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
Azita Moharamkhani
Position
Master's student, presenter
Other areas of specialty/work
Street address
Isfahan- East Azarbayjan-Arghavaniyeh- University Blvd.
City
Isfahan
Postal code
8155139998
Phone
+98 922 602 8413
Fax
Email
moharamkhani27@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)