The aim of this study is to determine the effect of auricular acupressure on the quality of life of postmenopausal women.
Design
Three arm parallel group, randomised trial, with single-blind outcome assessment
Settings and conduct
This three arm clinical trials will be conducted on postmenopausal women who have inclusion criteria. After confirming the inclusion criteria demographic and specific quality of life questionnaire for menopause will be completed. Then, the patients were randomly allocated to interventional and control groups.The sample size, including the attrition will be 45 for each group. The midwife who help to complete the questionnaires is unaware of the type of group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The patient's willingness to participate in this study
Residence in Mashhad
Having an age between 45-60
Non-use of tobacco
Non-menstruation at least 12 months ago
natural Menopause
Women who have any of the physical and psychological symptoms such as flushing, sweating, sleeplessness, anxiety, depression, etc.
Menopause is less than 10 years
No history of surgery on the ovary
No current use of any herbal medicine
Not receiving hormonal and non-hormonal drugs in the last 6 months to reduce menopausal complications
No history of cardiovascular disease in the past 6 months
Not having thyroid disease
Not having a history of abnormal vaginal bleeding
Not using other complementary therapies
Exclusion criteria:
Unwillingness to continue cooperation
Doing Acupressure less than twice a week
Intervention groups
Three groups of intervention (1-auricular acupressure with seed) and 2- control group (auricular acupressure without seed) and (routine care)
Main outcome variables
The quality of life for menopause, which in fact measures the annoying symptoms of this period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160731029134N2
Registration date:2019-01-11, 1397/10/21
Registration timing:registered_while_recruiting
Last update:2019-01-11, 1397/10/21
Update count:0
Registration date
2019-01-11, 1397/10/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 1795
Email address
hadizadehz941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-03, 1397/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auricular acupressure on the quality of life of postmenopausal women
Public title
The effect of auricular acupressure on the quality of life of postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's willingness to participate in this study
Residence in Mashhad
Having an age between 45-60
Non-use of tobacco
Non-menstruation at least 12 months ago
natural Menopause
Women who have any of the physical and psychological symptoms such as flushing, sweating, sleeplessness, anxiety, depression, etc
Menopause is less than 10 years
No history of surgery on the ovary
No current use of any herbal medicine
Not receiving hormonal and non-hormonal drugs in the last 6 months to reduce menopausal complications
No history of cardiovascular disease in the past 6 months
Not having thyroid disease
Not having a history of abnormal vaginal bleeding
Not using other complementary therapies
Exclusion criteria:
Unwillingness to continue cooperation
Doing Acupressure less than twice a week
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible patients are selected using convenience sampling method and then, using random numbers table, samples will be divided into three groups A, B and C.
Blinding (investigator's opinion)
Single blinded
Blinding description
Variables are measured by the assessor (a trained midwife) who is blind to blind intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Avenue next to the cinema Hoveizeh- Mashhad Medical Sciences, Ghoreishi building
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91375
Approval date
2017-05-06, 1396/02/16
Ethics committee reference number
IR.MUMS.REC.1396.23
Health conditions studied
1
Description of health condition studied
Menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
The quality of life for menopause, which in fact measures the annoying symptoms of this period.Determining the Four Dimensions of Quality of Life in Postmenopausal Women (Vasomotor, Psychosocial, Physical and Sexual)
Timepoint
At the beginning of the study and after four weeks
Method of measurement
Menopause-Specific Quality of Life Questionnaire
Secondary outcomes
1
Description
Signs and common complications of menopause including duration and severity of daily hot flashes
Timepoint
Daily
Method of measurement
Daily hot flash recording form
2
Description
Sleep status
Timepoint
At the beginning of the study and after four weeks
Method of measurement
Pittsburgh Sleep Quality Questionnaire
3
Description
Anxiety
Timepoint
At the beginning of the study and after four weeks
Method of measurement
Hamilton Anxiety Rating Scale
Intervention groups
1
Description
Intervention group: in the auricular acupressure group (AG), participants received ear adhesive tape with seed, on the ear sympathetic (AH6a), shenmen (TF4), adrenal gland (TG2p), subcortex (AT4), endocrine (CO18), kidney (CO10), heart (CO15) and liver (CO12) points for both ears.The patients were asked to press the acupoints by themselves four times a day for a 20 second duration each time for four week.It was explainedthat the strength of the pressing should make the local auriclecongestive, flushed, hot and achy.
Category
Treatment - Other
2
Description
Control group: In one control group , participants received ear adhesive tape without seed, on the ear sympathetic (AH6a), shenmen (TF4), adrenal gland (TG2p), subcortex (AT4), endocrine (CO18), kidney (CO10), heart (CO15) and liver (CO12) points for both ears.We note control group not to touch the adhesive.To use the potential psychological effects of adhesive, people are said these adhesives can improve symptoms.
Category
Placebo
3
Description
Control group: routine care includes self-care, including doing exercise and walking, diet (such as dairy consumption, a diet containing soy, no spices) and calcium supplementation and vitamin D, exposure to sunlight wearing appropriate cotton clothing, deep breathing during flushing, avoid being near-smoker, do not smoke, recommendations to lie down, or sit on a chair and tilted her head back in the time of flushing, activities to improve sleep, such as shower before bed, eat 1 cup of warm milk, no tea and coffee at the end of the night, ointment lubricant to reduce vaginal dryness during intercourse, it is recommended to maintain sexual relations regularly, activities to reduce anxiety such as doing yoga, and socially active.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Acupuncture Centers & Health Centers
Full name of responsible person
Zahra Hadizadeh-talasaz
Street address
Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi building, Mashhad University of Medical Science،behind of Hoveyzeh cinema،ِِDanesgah street، Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91375
Phone
+98 51 3841 3007
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Hadizadeh-talasaz
Position
Ph.D. student of reproductive health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ibnsina street -Crossroads Doctora-Danesgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
00989137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
Hadizadehz941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboubeh Firouzi
Position
مربی
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina street,Danesgah Street ,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
00989137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
Firouzim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Hadizadeh-talasaz
Position
Ph.D. student of reproductive health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina street,Danesgah Street ,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
00989137913199
Phone
+98 51 3859 1511
Email
Hadizadehz941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available