the effect of exercise and acupressure on flushing among women with breast cancer
Design
Patients will be assigned to three groups of exercise, acupressure and control using RAS software. To hide the allocation, the type of intervention will be written on the paper and will be inserted Inside the opaque envelopes.
Settings and conduct
This study was conducted on 99 women with breast cancer (after the completion of chemotherapy and radiotherapy) referring to the oncology clinic located at Imam Reza and Al-Zahra educational centers in Tabriz.
Participants/Inclusion and exclusion criteria
Entry requirements include women with breast cancer who have completed their chemotherapy and radiotherapy and have hot flashes, and have no cardiovascular disease or motor disorder. Unsupported conditions include hot flashes before breast cancer and over 45 years of age, and continuation of chemotherapy and radiotherapy.
Intervention groups
For the acupressure group, the pressure on the HE7 and HE GU points on the hands and Sp6 point will be applied to the feet. Pressure on these points will be performed three days a week for 15 minutes, with 3 minutes of pressure for each point and 2 minutes for the spot, under the supervision of an acupuncturist (collaborator) at their office for 8 weeks. For a sports activity group, an aerobic exercise program is considered in an exercise room under the supervision of a sports coach, a weekly 3 days for 60 minutes in 8 weeks. During this period, the researcher will supervise the exercise program on a regular basis. The control group will receive routine care from an oncology specialist along with both acupuncture and exercise intervention groups.
Main outcome variables
The amount of flushing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150424021917N8
Registration date:2018-06-03, 1397/03/13
Registration timing:registered_while_recruiting
Last update:2018-06-03, 1397/03/13
Update count:0
Registration date
2018-06-03, 1397/03/13
Registrant information
Name
Sevil Hakimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hakimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-22, 1397/02/02
Expected recruitment end date
2018-10-24, 1397/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise and acupressure on flushing in women with breast cancer
Public title
The effect of exercise and acupressure on hot flash
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years old
Women with hot flash at least twice a day for 6 weeks
Completion of radiotherapy and chemotherapy at least 8 weeks before, the next referral of chemotherapy at least 10 weeks later
Women with 5 or more score in pittsburgh sleep disturbances questionnaire
Women with ductal or lobular insitu breast cancer or 1,2,3 stage without metastastasis
Without experience hot flash before breast cancer
without any sensory motor disorder
Exclusion criteria:
Women with BMI higher than 30 kg/m2
Use of hot flash reducing and sedative drugs
Women with hyperthyroidism
Doing any kind of exercise regularly and professionally
Apply acupuncture within 2 weeks before starting the study
Cardiovascular disease
Restrictions on physical activity
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Using RAS software, through blocks with six and nine blocks will randomly (There are groups, in each group in which 6 or 9 people come in each category)assigned to Three groups of exercise, acupressure and control . To hide the allocation, the type of intervention will be written on paper and placed inside the packets matched and numbered sequentially(Allocation Concealment)
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 Tabriz University of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.TBZMED.REC.1396.926
Health conditions studied
1
Description of health condition studied
flushing
ICD-10 code
R23.2
ICD-10 code description
Flushing
Primary outcomes
1
Description
hot flash
Timepoint
Before Intervention,Week 4 Intervention and Week 8 Intervention
Method of measurement
Hot flash scale
Secondary outcomes
1
Description
sleep disorders
Timepoint
Before intervention, week 4 intervention and week 8 intervention
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Satisfaction with the treatment
Timepoint
after intervention
Method of measurement
Survey
Intervention groups
1
Description
Intervention: acupressure.For the acupressure group, the pressure on the HE7 and HE GU points on the hands and Sp6 point will be applied to the feet. Pressure on these points will be performed three days a week for 15 minutes, with 3 minutes of pressure for each point and 2 minutes for the spot, under the supervision of an acupuncturist (collaborator) at their office for 8 weeks.
Category
Treatment - Other
2
Description
Intervention group: Sports activities.For a sports activity group, an aerobic exercise program is considered in an exercise room under the supervision of a sports coach, a weekly 3 days for 60 minutes in 8 weeks. During this period, the researcher will supervise the exercise program on a regular basis.
Category
Lifestyle
3
Description
Control group: Receives routine training,In accordance with,tutorials provided in the program of the ministry of Saba(Iranian women's health)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy-Oncology Clinic of Imam Reza Hospital
Full name of responsible person
Reza Eghdamzamiri
Street address
university avenue, 29 Bahman Boulevard, Imam reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
۳۳۳۵۹۶۸۰
Phone
+98 41 3335 5921
Email
shadikhanipoor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Abolghasem Jouyban
Street address
29 Bahman Boulevard, Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
۳۳۳۵۵۹۲۱
Phone
+98 41 3335 5921
Email
shadikhanipoor@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shariati Boulevard, Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
hakimis@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil hakimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and midwifery Faculty, Shariati Avenue. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3475 3907
Email
hakimis@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shariati BLV,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
hakimis@tbzmed.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
Start publishing period 6 months after printing results
To whom data/document is available
Only available to scholars working in academic institutions
Under which criteria data/document could be used
All university students and scholars. By email
From where data/document is obtainable
Sevil Hakimi
hakimis@tbzmed.ac.ir
What processes are involved for a request to access data/document
The applicant sends an application via e-mail. After receiving the email, the results will be sent