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General information
2020-10-21, 1399/07/30
2021-01-20, 1399/11/01
20202021-1001-2120 00:00:00
2021-01-19, 1399/10/30
2021-04-19, 1400/01/30
2021-0104-19 00:00:00
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Change the time and place of sampling
Change the time and place of sampling
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تغییر زمان و محل نمونه گیری
تغییر زمان و محل نمونه گیری
Recruitment centers
#1
Name of recruitment center - English: Ahwaz University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی اهواز
Full name of responsible person - English: Mona Eidani
Full name of responsible person - Persian: منا عیدانی
Street address - English: North Abuzar Alley 10, Sadat St, Taleghani Town
Street address - Persian: شهرک طالقانی، خیابان سادات، کوچه ابوذر شمالی 10
City - English: Mahshahr
City - Persian: ماهشهر
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 63531-96474
Phone: +98 61 5244 0028
Fax:
Email: m.eidany1363@gmail.com
Web page address:
Name of recruitment center - English: Mahshahr Health Centers
Name of recruitment center - Persian: مراکز بهداشتی- درمانی ماهشهر
Full name of responsible person - English: Mona Eidani
Full name of responsible person - Persian: منا عیدانی
Street address - English: North Abuzar Alley 10, Sadat St, Taleghani Town
Street address - Persian: شهرک طالقانی، خیابان سادات، کوچه ابوذر شمالی 10
City - English: Mahshahr
City - Persian: ماهشهر
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 63531-96474
Phone: +98 61 5244 0028
Fax:
Email: m.eidany1363@gmail.com
Web page address:
Name of recruitment center - English: Ahwaz University of Medical SciencesMahshahr Health Centers Name of recruitment center - Persian: دانشگاه علوم پزشکی اهوازمراکز بهداشتی- درمانی ماهشهر Full name of responsible person - English: Mona Eidani Full name of responsible person - Persian: منا عیدانی Street address - English: North Abuzar Alley 10, Sadat St, Taleghani Town Street address - Persian: شهرک طالقانی، خیابان سادات، کوچه ابوذر شمالی 10 City - English: Mahshahr City - Persian: ماهشهر Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 63531-96474 Phone: +98 61 5244 0028 Fax: Email: m.eidany1363@gmail.com Web page address:
Protocol summary
Study aim
Determining the effect of Auriculotherapy on the quality of postmenopausal women
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 41 patients.
Settings and conduct
Clinical trial on the quality of sleep of postmenopausal women referring to health centers using Auricholotherapy device. After selecting the research units, the individuals will be randomly assigned a 1: 1 allocation ratio in 4 blocks, which will be used to hide the allocation of envelopes in the matte package, which will be numbered sequentially.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Amenorrhea for at least 12 months
- Age 60-45
- Get a score of more than 5 from the Pittsburgh questionnaire
Output Criteria:
- Having a known underlying disease
- The emergence of any physical and mental illness during the research
- Use of hormone therapy The use of sleeping pills during the last three months and during the study
- Alcohol and drug use
- Severe uterine bleeding
- Loss of a relative during the last 6 months and during the study
- Using other traditional treatments and complementary medicine
- The emergence of significant changes in sleep conditions unpredictably
- Take any herbal or chemical sleeping pills
- Having edema and inflammation in both ears
Intervention groups
Intervention group: Auricholotherapy by stimulating the main points
Witness group: Auricholotherapy by stimulating false spots
Main outcome variables
sleep quality; Mental quality of sleep; Sleep duration; Delay in falling asleep; The number of times you wake up at night; Sleep efficiency; Daily dysfunction
General information
Reason for update
Change the time and place of sampling
Acronym
IRCT registration information
IRCT registration number:IRCT20200613047756N1
Registration date:2020-07-19, 1399/04/29
Registration timing:prospective
Last update:2021-01-11, 1399/10/22
Update count:1
Registration date
2020-07-19, 1399/04/29
Registrant information
Name
mona eidani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5224 0028
Email address
eidani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auriculotherapy on sleep quality in postmenopausal women
Public title
The effect of auriculotherapy on sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Amenorrhea for at least 12 months
Ages 60-45
Get a score of more than 5 from the Pittsburgh Questionnaire
Exclusion criteria:
Having a known underlying disease (heart, kidney, thyroid, hypertension, diabetes, etc.)
The emergence of any physical or mental illness during research that causes sleep disorders
Use of hormone therapy, Armatase inhibitors, clonidine and antidepressants, sleeping pills during the last three months and during the study
Consumption of alcohol and addictive substances and tobacco
Severe uterine bleeding
Loss of a relative during the last 6 months and during the study
Use of other traditional therapies and complementary medicine in the last 4 weeks during the study
Emergence of significant change in unpredictable sleep conditions, including travel, relocation
Take any herbal or chemical sleeping pills
Having edema and inflammation in both ears
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the research units, the individuals will be randomly assigned 1: 1 in blocks of 4. In order to hide the allocation, envelopes will be used in the matte package, which are numbered in order and the type of intervention is written inside them.These envelopes will be prepared by the researcher involved in collecting data that is not known from the research.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to hide the allocation, envelopes will be used in matte packages, which are numbered in order and the type of intervention is written inside them. These envelopes will be prepared by a non-involved researcher in data collection.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
North Abuzar Ally 10, Sadat St, Taleghani Town
City
Mahshahr
Province
Khouzestan
Postal code
63531-96474
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.AJUMS.REC.1399.230
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
G47 G47.0
ICD-10 code description
VI Diseases of the nervous system , Sleep disorders , Disorders of initiating and maintaining sleep [insomnias], Disorders of excessive somnolence [hypersomnias] Disorders of the sleep-wake schedule. Sleep apnoea ,Narcolepsy and cataplexy , Other sleep
Primary outcomes
1
Description
Sleep quality score in the Pittsburgh questionnaire
Timepoint
Completion of the questionnaire then 4 weeks of intervention with the Auriculotherapy device and re-completion of the questionnaire
Method of measurement
Pittsburgh Questionnaire
Secondary outcomes
1
Description
Sleep Mental Quality Score in the Pittsburgh Questionnaire
Timepoint
Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire
Method of measurement
Pittsburgh Questionnaire
2
Description
Sleep efficiency score on the Pittsburgh questionnaire
Timepoint
Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire
Method of measurement
Pittsburgh Questionnaire
3
Description
Daily Performance Disorder Score in the Pittsburgh Questionnaire
Timepoint
Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire
Method of measurement
Pittsburgh Questionnaire
Intervention groups
1
Description
Intervention group: In this experiment, using an Excel 2 AUrycolotherapy device made in China, the main points related to sleep in the right ear are stimulated for 15 seconds, The plantar warts are then attached to the irritated spots of Vakaria, and it is recommended that the person be pressured for one minute every hour except for bedtime and return after 6 days. The duration of the intervention was 4 weeks.
Category
Treatment - Devices
2
Description
Control group: n this experiment, using an Excel 2 Aurycolotherapy device made in China, the false spots on the back of the right ear are stimulated for 15 seconds.Then, on the irritated areas, the plantar fissures of Vakaria are glued without a nut, and it is recommended that the person press the seedlings for one minute every hour, except for bedtime, and return after 6 days. The intervention period was 4 weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahshahr Health Centers
Full name of responsible person
Mona Eidani
Street address
North Abuzar Alley 10, Sadat St, Taleghani Town
City
Mahshahr
Province
Khouzestan
Postal code
63531-96474
Phone
+98 61 5244 0028
Email
m.eidany1363@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ground Floor, Ahwaz Jundishapur University of Medical Sciences and Health Services Vice Chancellor for Research and Technology,Academic City
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
iitc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mona Eidani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
North Abuzar Alley 10, Sadat St, Taleghani Town
City
Mahshahr
Province
Khouzestan
Postal code
63531-96474
Phone
+98 61 5244 0028
Email
m.eidany1363@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mona Eidani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
North Abuzar Alley 10, Sadat St, Taleghani Town
City
Mahshar
Province
Khouzestan
Postal code
63531-96474
Phone
+98 61 5244 0028
Email
m.eidany1363@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mona Eidani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
North Abuzar Alley 10, Sadat St, Taleghani Town
City
Mahshahr
Province
Khouzestan
Postal code
63531-96474
Phone
+98 61 5244 0028
Email
m.eidany1363@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
No - There is not 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
Yes - There is a plan to make this available
Title and more details about the data/document
All Study data includes primary and secondary outcomes and other study data after non-identifiable shareable individuals.
When the data will become available and for how long
Study data will be available 6 months after the results are published.
To whom data/document is available
Other study documents should be made available to the public.
Under which criteria data/document could be used
Individuals with the name of the study researcher are allowed to use the study documents, individuals are not allowed to analyze any of the submitted data.
From where data/document is obtainable
To receive the documents, people can contact the following mailing address: m.eidany1363@gmail.com
What processes are involved for a request to access data/document
The applicant of these documents will respond to the request within 24 hours after the request is sent via e-mail, and the relevant files will be provided to the applicant.