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Protocol summary
هدف کلی: اثر رایحه گل محمدی بر کیفیت خواب زنان در دوره نفاس تعیین گردد.
اثر رایحه گل محمدی بر کیفیت خواب زنان در دوره نفاس
هدف کلی: اثر رایحه گل محمدی بر کیفیت خواب زنان در دوره نفاس تعیین گردد.
A randomized controlled clinical trial with parallel groups, randomized, without blinding
A clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 84 people, a random number table was used for randomization.
A randomized controlled clinical trial with a control group, with parallel groups, without blinding, randomized, without blindingphase 3 on 84 people, a random number table was used for randomization.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، بدون کور سازی، تصادفی شده
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، بدون کور سازی، تصادفی شده، فاز 3 بر روی 84 نفر، برای تصادفی سازی از جدول اعداد تصادفی استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، بدون کور سازی، تصادفی شده، فاز 3 بر روی 84 نفر، برای تصادفی سازی از جدول اعداد تصادفی استفاده شد.
Aromatherapy - Home and self intervention - Three nights of inhalation of a rose that pinned to the pillow
Aromatherapy - Home and self intervention - Three nights of inhalation of a rose that pinned to the pillow. The project was carried out in Arak city and between clients of health clinics.
Aromatherapy - Home and self intervention - Three nights of inhalation of a rose that pinned to the pillow. The project was carried out in Arak city and between clients of health clinics.
آروماتراپی- انجام مداخله در منزل و توسط خود شخص- سه شب استنشاق رایحه گل محمدی که به دستمال آغشته شده و به بالش سنجاق می شود.
آروماتراپی- انجام مداخله در منزل و توسط خود شخص- سه شب استنشاق رایحه گل محمدی که به دستمال آغشته شده و به بالش سنجاق می شود.طرح در شهر اراک و بین مراجعین به درمانگاه های بهداشتی انجام شد.
آروماتراپی- انجام مداخله در منزل و توسط خود شخص- سه شب استنشاق رایحه گل محمدی که به دستمال آغشته شده و به بالش سنجاق می شودشود.طرح در شهر اراک و بین مراجعین به درمانگاه های بهداشتی انجام شد.
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
Inclusion criteria: Lack of severe pain disruptive sleep
; Lack of experience in aromatherapy
; Do not use complementary medicine in the last week
; Awareness (awareness of time, place and person)
; Lack of underlying disease affecting sleep (such as rheumatoid arthritis and migraine)
; No known sleep disorder according to the patient
; No history of asthma and allergies
No history of allergies and eczema to flowers and plants and the smell of sweat and their essential oils
; Do not take drugs 6 hours before bedtime
; Not addicted
; Do not take psychiatric drugs
; Lack of care or treatment plan during bedtime
; Lack of orthopnea and respiratory problems
; Baby age 20 to 25 days
; Exclusive breastfeeding
; Criteria for not entering:
; Severe sensitivity to the scent of rosemary during the study.
; The patient's unwillingness to continue participating in the study
; Arbitrary use of sedatives
; Orthopedics and respiratory problems during the study
; The patient becomes ill
Inclusion criteria: 1) Lack of severe pain disruptive sleep 2); Lack of experience in aromatherapy experience until now 3) Not using; Do not use complementary medicine in recent weeks 4) Being alertthe last week ; Awareness (knowingawareness of time, place and person) 5); Lack of sleeping conditionsunderlying disease affecting sleep (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 aNo history of allergyallergies and eczema to flowers and plants and the smell of sweat and their essential oils 9) Not taking; Do not take drugs 6 hours before bedtime 10); Not being addicted 11) No use of psychotropic; Do not take psychiatric drugs 12); Lack of care or treatment plan during bedtime 13); Lack of orthopnea and respiratory problems 14); Baby age 20 -to 25 days Exclusion criteria 15); Exclusive Breastfeeding 1)breastfeeding ; Criteria for not entering: ; Severe sensitivity to the scent of rose flowersrosemary 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; The patient becomes ill
معیارهای ورود: 1)فقدان درد شدید مخل خواب
2)عدم تجربه آروماتراپی تا به حال
3)عدم استفاده از طب مکمل در هفته اخیر
4)هوشیار بودن (آگاهی به زمان، مکان و شخص)
5)نداشتن بیماری زمینهای مؤثر بر خواب (همانند آرتریت روماتوئید و میگرن)
6)نداشتن اختلال خواب شناخته شده طبق اظهار بیمار
7)نداشتن سابقه ی بیماری آسم و آلرژی
8)نداشتن سابقه ی حساسیت و اگزما به گل ها و گیاهان و بوی عرق و اسانس آنها
9) مصرف نکردن مواد مخدر 6 ساعت قبل از خواب
10)معتاد نبودن
11)عدم مصرف داروهای اعصاب و روان
12)نداشتن برنامه ی مراقبتی یا درمانی در طی ساعات خواب
13)فقدان ارتوپنه و مشکل تنفسی
14)سن نوزاد 20 الی 25 روز
15)تغذیه انحصاری با شیر مادر
معیارهای عدم ورود:
1)حساسیت شدید به رایحه گل محمدی در طول مطالعه.
2)عدم تمایل بیمار به ادامه شرکت در مطالعه
3)مصرف خودسرانه ی داروهای آرام بخش
4)ارتوپنه و مشکل تنفسی حین مطالعه
5)بدحال شدن بیمار
معیارهای ورود: فقدان درد شدید مخل خواب
; عدم تجربه آروماتراپی تا به حال
; عدم استفاده از طب مکمل در هفته اخیر
; هوشیار بودن (آگاهی به زمان، مکان و شخص)
; نداشتن بیماری زمینهای مؤثر بر خواب (همانند آرتریت روماتوئید و میگرن)
; نداشتن اختلال خواب شناخته شده طبق اظهار بیمار
; نداشتن سابقه ی بیماری آسم و آلرژی
;نداشتن سابقه ی حساسیت و اگزما به گل ها و گیاهان و بوی عرق و اسانس آنها
; مصرف نکردن مواد مخدر 6 ساعت قبل از خواب
; معتاد نبودن
; عدم مصرف داروهای اعصاب و روان
; نداشتن برنامه ی مراقبتی یا درمانی در طی ساعات خواب
; فقدان ارتوپنه و مشکل تنفسی
; سن نوزاد 20 الی 25 روز
; تغذیه انحصاری با شیر مادر
; معیارهای عدم ورود:
; حساسیت شدید به رایحه گل محمدی در طول مطالعه.
; عدم تمایل بیمار به ادامه شرکت در مطالعه
; مصرف خودسرانه ی داروهای آرام بخش
; ارتوپنه و مشکل تنفسی حین مطالعه
; بدحال شدن بیمار
معیارهای ورود: 1)فقدانفقدان درد شدید مخل خواب 2)عدم; عدم تجربه آروماتراپی تا به حال 3)عدم; عدم استفاده از طب مکمل در هفته اخیر 4)هوشیار; هوشیار بودن (آگاهی به زمان، مکان و شخص) 5)نداشتن; نداشتن بیماری زمینهای مؤثر بر خواب (همانند آرتریت روماتوئید و میگرن) 6)نداشتن; نداشتن اختلال خواب شناخته شده طبق اظهار بیمار 7)نداشتن; نداشتن سابقه ی بیماری آسم و آلرژی 8)نداشتن;نداشتن سابقه ی حساسیت و اگزما به گل ها و گیاهان و بوی عرق و اسانس آنها 9); مصرف نکردن مواد مخدر 6 ساعت قبل از خواب 10)معتاد; معتاد نبودن 11)عدم; عدم مصرف داروهای اعصاب و روان 12)نداشتن; نداشتن برنامه ی مراقبتی یا درمانی در طی ساعات خواب 13)فقدان; فقدان ارتوپنه و مشکل تنفسی 14)سن; سن نوزاد 20 الی 25 روز 15)تغذیه; تغذیه انحصاری با شیر مادر ; معیارهای عدم ورود: 1)حساسیت; حساسیت شدید به رایحه گل محمدی در طول مطالعه. 2)عدم; عدم تمایل بیمار به ادامه شرکت در مطالعه 3)مصرف; مصرف خودسرانه ی داروهای آرام بخش 4)ارتوپنه; ارتوپنه و مشکل تنفسی حین مطالعه 5)بدحال; بدحال شدن بیمار
General information
N/A
3
na3
empty
84
84
empty
2019-12-03, 1398/09/12
2019-12-03 00:00:00
empty
2020-03-18, 1398/12/28
2020-03-18 00:00:00
empty
2020-05-19, 1399/02/30
2020-05-19 00:00:00
empty
Record sampling date
Record sampling date
empty
ثبت تاریخ نمونه گیری
ثبت تاریخ نمونه گیری
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
Cluster sampling:
According to cluster sampling, health centers will be selected by lot from 5 districts of Arak city and then sampling will be done from each of the selected clinics in proportion to the population covered.
Random number table: Randomly divide people into two groups of 42 people intervention and control, assign a three-digit code to each person and then create a number table, randomly select three consecutive numbers in a row or column.
Cluster sampling: ByAccording to cluster sampling, health centers arewill be selected by lot from 5 districts of Arak city and then sampledsampling will be done from each of the selected clinics in proportion to the population covered. Random Number Tablenumber table: Randomly divideddivide people into two groups of 42 people intervention and control groups, assign a three-digit code to each person and then create a number table, randomly select three consecutive numbers in a row or column.
نمونه گیری خوشه ای:
طبق نمونه گیری خوشه ای ، به قید قرعه از 5 منطقه شهرستان اراک مراکز بهداشتی انتخاب میشوند و سپس از هرکدام از درمانگاه های منتخب به نسبت جمعیت تحت پوشش، نمونه گیری خواهد شد.
جدول اعداد تصادفی: تقسیم تصادفی افراد به دو گروه 42 نفره مداخله و کنترل
نمونه گیری خوشه ای:
طبق نمونه گیری خوشه ای ، به قید قرعه از 5 منطقه شهرستان اراک مراکز بهداشتی انتخاب میشوند و سپس از هرکدام از درمانگاه های منتخب به نسبت جمعیت تحت پوشش نمونه گیری خواهد شد.
جدول اعداد تصادفی: تقسیم تصادفی افراد به دو گروه 42 نفره مداخله و کنترل، اختصاص کد سه رقمی به هر فرد و سپس ایجاد جدول اعداد،انتخاب تصادفی سه عدد پشت سر هم در یک سطر یا یک ستون.
نمونه گیری خوشه ای: طبق نمونه گیری خوشه ای ، به قید قرعه از 5 منطقه شهرستان اراک مراکز بهداشتی انتخاب میشوند و سپس از هرکدام از درمانگاه های منتخب به نسبت جمعیت تحت پوشش، نمونه گیری خواهد شد. جدول اعداد تصادفی: تقسیم تصادفی افراد به دو گروه 42 نفره مداخله و کنترل، اختصاص کد سه رقمی به هر فرد و سپس ایجاد جدول اعداد،انتخاب تصادفی سه عدد پشت سر هم در یک سطر یا یک ستون.
Intervention groups
#1
Intervention group: Inhale the Mohammadi scent for three consecutive nights.
Intervention group: Inhaling the scent of Mohammadi flower from 10% essential oil of Mohammadi flower made in by Barij company, Iran, for three consecutive nights and for at least 8 hours every night.
Intervention group: InhaleInhaling the scent of Mohammadi scentflower from 10% essential oil of Mohammadi flower made in by Barij company, Iran, for three consecutive nights and for at least 8 hours every night.
Protocol summary
Study aim
The effect of rose flower aroma on sleep quality of women during the postpartum
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 84 people, a random number table was used for randomization.
Settings and conduct
Aromatherapy - Home and self intervention - Three nights of inhalation of a rose that pinned to the pillow. The project was carried out in Arak city and between clients of health clinics.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lack of severe pain disruptive sleep
; Lack of experience in aromatherapy
; Do not use complementary medicine in the last week
; Awareness (awareness of time, place and person)
; Lack of underlying disease affecting sleep (such as rheumatoid arthritis and migraine)
; No known sleep disorder according to the patient
; No history of asthma and allergies
No history of allergies and eczema to flowers and plants and the smell of sweat and their essential oils
; Do not take drugs 6 hours before bedtime
; Not addicted
; Do not take psychiatric drugs
; Lack of care or treatment plan during bedtime
; Lack of orthopnea and respiratory problems
; Baby age 20 to 25 days
; Exclusive breastfeeding
; Criteria for not entering:
; Severe sensitivity to the scent of rosemary during the study.
; The patient's unwillingness to continue participating in the study
; Arbitrary use of sedatives
; Orthopedics and respiratory problems during the study
; The patient becomes ill
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
Record sampling date
Acronym
IRCT registration information
IRCT registration number:IRCT20191013045079N1
Registration date:2019-11-05, 1398/08/14
Registration timing:prospective
Last update:2020-11-26, 1399/09/06
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
2019-12-03, 1398/09/12
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-05-19, 1399/02/30
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
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster sampling:
According to cluster sampling, health centers will be selected by lot from 5 districts of Arak city and then sampling will be done from each of the selected clinics in proportion to the population covered.
Random number table: Randomly divide people into two groups of 42 people intervention and control, assign a three-digit code to each person and then create a number table, randomly select three consecutive numbers in a row or column.
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: Inhaling the scent of Mohammadi flower from 10% essential oil of Mohammadi flower made in by Barij company, Iran, for three consecutive nights and for at least 8 hours every night.
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