Protocol summary
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Study aim
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Determining the effect of Auriculotherapy on the quality of postmenopausal women
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, on 41 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: Auricholotherapy by stimulating the main points
Witness group: Auricholotherapy by stimulating false spots
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Main outcome variables
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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
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Reason for update
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Change the time and place of sampling
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Acronym
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IRCT registration information
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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
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Registration date
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2020-07-19, 1399/04/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-04-19, 1400/01/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of auriculotherapy on sleep quality in postmenopausal women
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Public title
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The effect of auriculotherapy on sleep quality
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 45 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
41
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-10, 1399/03/21
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Ethics committee reference number
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IR.AJUMS.REC.1399.230
Health conditions studied
1
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Description of health condition studied
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sleep disorder
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ICD-10 code
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G47 G47.0
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ICD-10 code description
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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
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Description
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Sleep quality score in the Pittsburgh questionnaire
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Timepoint
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Completion of the questionnaire then 4 weeks of intervention with the Auriculotherapy device and re-completion of the questionnaire
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Method of measurement
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Pittsburgh Questionnaire
Secondary outcomes
1
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Description
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Sleep Mental Quality Score in the Pittsburgh Questionnaire
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Timepoint
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Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire
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Method of measurement
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Pittsburgh Questionnaire
2
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Description
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Sleep efficiency score on the Pittsburgh questionnaire
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Timepoint
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Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire
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Method of measurement
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Pittsburgh Questionnaire
3
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Description
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Daily Performance Disorder Score in the Pittsburgh Questionnaire
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Timepoint
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Completion of the questionnaire, then 4 weeks of intervention with the Auricotherapy device, then re-completion of the questionnaire
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Method of measurement
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Pittsburgh Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All Study data includes primary and secondary outcomes and other study data after non-identifiable shareable individuals.
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When the data will become available and for how long
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Study data will be available 6 months after the results are published.
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To whom data/document is available
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Other study documents should be made available to the public.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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To receive the documents, people can contact the following mailing address: m.eidany1363@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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