Investigating the comparative effectiveness of biofeedback and auriculotherapy on menopoused women’s hot flashes referred to private clinics of gynecologists in Kerman city, 2019
Investigating the comparative effectiveness of biofeedback and auriculotherapy on menopoused women’s hot flashes referred to private clinics of gynecologists
Design
Biofeedback Group:
This group uses a Canadian biofeedback device by a researcher to run the biofeedback. The biofeedbacks of each subject were recorded in the office and under controlled conditions and recorded as baseline (respiratory biofeedback, skin electrical response, skin temperature).
Auriculotherapy Group:
The researcher, after disinfecting the ear with 70% alcohol in endocrine, ovarian, Shen-man, Long-ears in the left ear, and Mr. Schulder in the right ear, stimulated anxiety, thalamic in the right ear by an Excel 2 device, and then labeled the Vakaria plant ( Sides) that can remain in the ear for three days in the ear at the specified point.r.
Settings and conduct
The present study is a quasi-experimental clinical trial study with control and intervention groups and pre- and post-test design. The sample of the study is women from the same community who meet the inclusion criteria.
Participants/Inclusion and exclusion criteria
1- At least one year after menstruation
2 - Hot flashes at least twice a day
3 - age 60-45 years
4. Willingness to participate in the research project and to complete the written consent form
5- Being Iranian
Intervention groups
The control, biofeedback and uriculotherapy groups were randomly divided. Before intervention, demographic questionnaires and hot flash questionnaires were completed by all three groups. The intervention will receive two sessions per week and each session runs 30 minutes individually for 5 weeks.
Main outcome variables
Hot flashes
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20190728044351N1
Registration date:2019-08-27, 1398/06/05
Registration timing:registered_while_recruiting
Last update:2019-08-27, 1398/06/05
Update count:0
Registration date
2019-08-27, 1398/06/05
Registrant information
Name
somayeh eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3372 9130
Email address
sos.eslami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the comparative effectiveness of biofeedback and auriculotherapy on menopoused women’s hot flashes referred to private clinics of gynecologists in Kerman city, 2019
Public title
Investigating the comparative effectiveness of biofeedback and auriculotherapy on menopoused women’s hot flashes referred to private clinics of gynecologists
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year after menstruation
Hot flashes at least twice a day
Age 60-45 years old
Willingness to participate in the research project and to complete the written consent form
Being Iranian
Exclusion criteria:
History of hysterectomy and ophorectomy
Hypertension and Cardiovascular Diseases, Thromboembolic, Thyroid Endocrine
Use of tobacco or alcohol
Malignancy
Abnormal vaginal bleeding
taking hormones and taking drugs that affect vasomotor symptoms
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random and accessible
All postmenopausal women referred to the gynecologist's office within the first 4 days of the week
Which are divided into throwing coins into specified 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 Kerman University of Medical Sciences
Street address
Seven Garden Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-07-24, 1398/05/02
Ethics committee reference number
IR.KMU.REC.1398.202
Health conditions studied
1
Description of health condition studied
Hot flashes
ICD-10 code
Z76.89
ICD-10 code description
Chapter XXIFactors influencing health status and contact with health services(Z00-Z99)
Primary outcomes
1
Description
Hot flashes
Timepoint
Before intervention, demographic questionnaire and hot flash questionnaire were completed by all three groups and completed 4 weeks and 8 weeks after the intervention.
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Biofeedback Group:In this group of Canadian biofeedback device BioGraph Infiniti V4 Plus (Infiniti SN: CB1726 \ Enc Key Cod:(848981408 \ App Key Code: 1589114055 is used by the researcher to perform biofeedback. Each subject in the office and under controlled conditions, the relevant biofeedback is recorded and recorded as a baseline.Respiratory Biofeedback: In a respiratory biofeedback, the relevant sensors are installed around the person's chest and the person is instructed to look at the training monitor to change their breathing pattern.Biofeedback for heart rate: This type of biofeedback is known as a method for heart rate variability. As the name implies, it helps the person control their heart rate.Skin response: In skin response method, the sweat of the skin surface is measured. The level of sweating on the skin, called the skin's electrical response, is a good criterion for examining emotions in a person. That is, the emotional state of the skin's electrical response changes.Skin temperature: People experience a decrease in skin temperature during stress. By monitoring skin temperature, people learn when to enter the stress and anxiety phase and how they can control it.
Category
Behavior
2
Description
Intervention group: Biofeedback Group:Uriculotherapy Group:Researcher after disinfecting the ear with 70% alcohol in endocrine, ovarian, Shen Man, Long I in the left ear and Master Scholler points in anxiety, thalamic in the right ear by Excel 2 device, stimulated each point for 5 seconds and then Put labels containing the plant Vakaria (Say) that can remain in spots for three days at the specified points in the ears and teach the study subjects to sit on the spot every two hours for one minute with Press the finger (emphasis added to the extent that it causes pain and burning in the outer ear).
Category
Treatment - Devices
3
Description
Control group: Control group receiving routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecologist's office
Full name of responsible person
Somayeh Sadat Eslami
Street address
Seven Garden Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3340 1256
Email
sos.eslami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Pardakhti
Street address
Jahad Street
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3340 1256
Email
sos.eslami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Neuroscience Research Center
Proportion provided by this source
60
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
Kerman University of Medical Sciences
Full name of responsible person
Somayeh Sadat Eslami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Seven Garden Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3340 1256
Email
sos.eslami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayeh Sadat Eslami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Seven Garden Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3340 1256
Email
sos.eslami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayeh Sadat Eslami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Seven Garden Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3340 1256
Email
sos.eslami@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
Yes - There is a plan to make this available
Title and more details about the data/document
All individual data of study participants are shared after unidentifiable individuals
When the data will become available and for how long
The access period begins 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Applicable to complementary medicine groups
From where data/document is obtainable
Email address, or website, and phone and fax numbers, along with the names and addresses of the respondent
What processes are involved for a request to access data/document
Minimum time needed to get one week of documentation