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The effect of rose water aromatherapy on womenꞌs sleep quality in postpartum period

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History
# Registration date Revision Id
3 2020-11-11, 1399/08/21 160380
2 2019-11-05, 1398/08/14 110572
1 2019-11-05, 1398/08/14 110032
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  • Recruitment centers

    #1
    Name of recruitment center - English: Arak Health Centers
    Name of recruitment center - Persian: مراکز بهداشتی درمانی شهرستان اراک
    Full name of responsible person - English: hadis fattah
    Full name of responsible person - Persian: حدیث فتاح
    Street address - English: No. 22, Shariati Street, Palestinian Cui, shohada Alley
    Street address - Persian: خیابان شریعتی، کوی فلسطین،کوچه شهدا،پلاک22
    City - English: khoram abad
    City - Persian: خرم آباد
    Province: Lorestan
    Country: Iran (Islamic Republic of)
    Postal code: 6819767373
    Phone: +98 66 3340 6516
    Fax:
    Email: hadisfth@gmail.com
    Web page address:
    Name of recruitment center - English: Arak Health Centers
    Name of recruitment center - Persian: مراکز بهداشتی درمانی شهرستان اراک
    Full name of responsible person - English: Hadis Fattah
    Full name of responsible person - Persian: حدیث فتاح
    Street address - English: University complex of the Great Prophet., Sardasht
    Street address - Persian: سردشت، مجتمع دانشگاهی پیامبر اعظم
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3814957558
    Phone: +98 86 3417 3503
    Fax:
    Email: Hadisfth@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: hadis fattah
    Full name of responsible person - Persian: حدیث فتاح
    Street address - English: Sardasht - University complex of the Great Prophet
    Street address - Persian: سردشت- مجتمع دانشگاهی پیامبر اعظم
    City - English: arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 6819767373
    Phone: +98 66 3340 6516
    Fax:
    Email: hadisfth@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Kamali
    Full name of responsible person - Persian: علیرضا کمالی
    Street address - English: University complex of the Great Prophet., Sardasht
    Street address - Persian: سردشت، مجتمع دانشگاهی پیامبر اعظم
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 6819767373
    Phone: +98 66 3340 6516
    Fax:
    Email: Hadisfth@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hadis Fattah
    Full name of responsible person - Persian: حدیث فتاح
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 22 , Martyrs Alley., Palestinian Cui., Shariati Street
    Street address - Persian: خیابان شریعتی، کوی فلسطین، کوچه شهدا، پلاک 22
    City - English: Khoram Abad
    City - Persian: خرم آباد
    Province: Lorestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6819767373
    Phone: +98 66 3340 6516
    Mobile: +98 901 479 9295
    Fax:
    Email: hadisfth@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hadis Fattah
    Full name of responsible person - Persian: حدیث فتاح
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: University complex of the Great Prophet., Sardasht
    Street address - Persian: سردشت، مجتمع دانشگاهی پیامبر اعظم
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3814957558
    Phone: +98 86 3417 3503
    Mobile: +98 901 479 9295
    Fax:
    Email: hadisfth@gmail.com
    Web page address:

Protocol summary

Study aim
The effect of rose flower aroma on sleep quality of women during the postpartum
Design
A randomized controlled clinical trial with parallel groups, randomized, without blinding
Settings and conduct
Aromatherapy - Home and self intervention - Three nights of inhalation of a rose that pinned to the pillow
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Lack of severe pain disruptive sleep 2) Lack of aromatherapy experience until now 3) Not using complementary medicine in recent weeks 4) Being alert (knowing time, place and person) 5) Lack of sleeping conditions (such as rheumatoid arthritis and migraine) 6) No known sleep disorder according to the patient 7) No history of asthma and allergies 8) Not having a history of allergy and eczema to flowers and plants and the smell of sweat and their essential oils 9) Not taking drugs 6 hours before bedtime 10) Not being addicted 11) No use of psychotropic drugs 12) Lack of care or treatment during bedtime 13) Lack of orthopnea and respiratory problems 14) Baby age 20 -25 days Exclusion criteria 15) Exclusive Breastfeeding 1) Severe sensitivity to the scent of rose flowers during the study 2) The patient's unwillingness to continue participating in the study 3) Arbitrary use of sedatives 4) Orthopedics and respiratory problems during the study 5) Getting sick
Intervention groups
For 3 nights - the napkin is dipped in rose essential and pinned to the pillow. The control group will receive no intervention
Main outcome variables
women's sleep quality during the postpartum

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191013045079N1
Registration date: 2019-11-05, 1398/08/14
Registration timing: prospective

Last update: 2019-11-09, 1398/08/18
Update count: 2
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
hadis fattah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 6516
Email address
hadisfth@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-03, 1398/09/12
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rose water aromatherapy on womenꞌs sleep quality in postpartum period
Public title
The effect of rose aroma on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of severe pain disruptive sleep No experience of aromatherapy until now No use of complementary medicine in recent weeks Being alert (knowing time, place and person) Lack of sleeping conditions (such as rheumatoid arthritis and migraine) No known sleep disorder according to the patient No history of asthma and allergies Not having a history of allergy and eczema to flowers and plants and the smell of sweat and essential oils Do not take drugs 6 hours before bedtime Not being addicted No psychotropic drugs Lack of care or treatment during bedtime Lack of orthopnea and respiratory problems Baby age 20 to 25 days Exclusive Breastfeeding
Exclusion criteria:
Severe sensitivity to the scent of Mohammadi flowers during the study. Patient's unwillingness to continue participating in the study Arbitrary use of sedatives Orthopnea and Respiratory Difficulty During Study Getting sick
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster sampling: By cluster sampling, health centers are selected from 5 districts of Arak city and then sampled from each of the selected clinics in proportion to the population covered. Random Number Table: Randomly divided into two groups of 42 intervention and control groups
Blinding (investigator's opinion)
Not 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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences., Alam Hoda Street., Shahid Shiroudi Street., Arak
City
Arak
Province
Markazi
Postal code
6819763383
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.ARAKMU.REC.1398.176

Health conditions studied

1

Description of health condition studied
Poor sleep quality
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sleep quality
Timepoint
Baseline - After 3 nights inhalation of rose scent
Method of measurement
Petersburg questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Inhale the Mohammadi scent for three consecutive nights.
Category
Rehabilitation

2

Description
Control group: they will not receive any intervention
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Health Centers
Full name of responsible person
Hadis Fattah
Street address
University complex of the Great Prophet., Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3503
Email
Hadisfth@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
University complex of the Great Prophet., Sardasht
City
Arak
Province
Markazi
Postal code
6819767373
Phone
+98 66 3340 6516
Email
Hadisfth@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayoon Vakilian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Second Floor., Blue Wing Building., Prophet University Academic Complex., Sardasht
City
Arak
Province
Markazi
Postal code
6819767373
Phone
+98 86 3417 3503
Email
cattyv2002@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayoon Vakilian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Second Floor., Blue Wing Building., Prophet University Academic Complex., Sardasht
City
Arak
Province
Markazi
Postal code
6819767373
Phone
+98 86 3417 3503
Email
Cattyv2002@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadis Fattah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
University complex of the Great Prophet., Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3503
Fax
Email
hadisfth@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start accessing 6 months after printing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
No more conditions
From where data/document is obtainable
email
What processes are involved for a request to access data/document
Upon request by email
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