Provide a simple executive solution to reduce the anxiety of patients with breast cancer.
Design
In this study, 66 patients with breast cancer who were admitted to the Ayatollah Khansari Hospital in Arak were selected.
Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
The present study will be conducted at Ayatollah Khansari Hospital in Arak, and on women with breast cancer. The samples will not know how to place the samples in the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with breast cancer; no history of participation in anxiety management training classes; no history of participation in massage classes.
Exclusion criteria: unwillingness continued participation in the study; participant's death; immigration.
Intervention groups
After receiving permission from the patient and considering which patient is in the group, foot reflexology massage will be done for the intervention group and there will be no specific treatment for the control group.
Main outcome variables
Reducing anxiety in women with breast cancer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031328N6
Registration date:2018-01-24, 1396/11/04
Registration timing:registered_while_recruiting
Last update:2018-01-24, 1396/11/04
Update count:0
Registration date
2018-01-24, 1396/11/04
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
66 patients with breast cancer were entered into the study according to inclusion and exclusion criteria and randomly divided into two intervention and control groups using blocking method.
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on anxiety of women with breast cancer
Public title
The effect of foot reflexology on anxiety of women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
women with breast cancer
20-60 years old
no history of participation in anxiety management training classes
no history of participation in massage classes
willingness to participate in the study
Exclusion criteria:
unwillingness continued participation in the study
absences from more than one session of training sessions
immigration
participant's death
Age
From 19 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were divided into two intervention and control groups using randomized block assignment method and using the random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Samples and researcher will not know how to allocate to the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alam al hoda St, Rail road St
City
Arak
Province
Markazi
Postal code
38481-7-6941
Approval date
2017-09-11, 1396/06/20
Ethics committee reference number
IR.ARAKMU.REC.1396.139
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Anxiety related to breast cancer
Timepoint
Before the intervention at the morning and after the intervention at the evening.
Method of measurement
Using the Spielberger Anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massage of the anxiety point in the foot for 15 minutes before the intervention in the morning and after the intervention at the evening.
Category
Other
2
Description
Control group: No action is taken on control group samples
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari hospital
Full name of responsible person
Reza Aghabozorgi
Street address
The end of the university street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3367 5000
Email
head_khansari@arakmu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Sciences
Full name of responsible person
Dr Ali Arash Anoshirvani, Vice Chancellor for Research of Arak University of Medical Sciences
Street address
Vice Chancellor for research, Piambar Azam University complex, sardasht region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3639
Email
Rsearch@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Arak 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
Arak University of Medical Science
Full name of responsible person
Mohadeseh Rezaei
Position
BSc Student of Nursing
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Piambar Azam university complex, sardasht region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86341735057
Fax
Email
sajadimahbobeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Mahbobeh Sajadi
Position
PhD of Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Piambar Azam university complex, sardasht region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86341735057
Fax
Email
sajadimahbobeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Ph.D of Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Piambar Azam university complex, sardasht region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86341735057
Fax
Email
sajadimahbobeh@yahoo.com
Web page address
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared after unidentifiable of people.
When the data will become available and for how long
The beginning of the access period is 2 years after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
Dr Mahboubeh Sajjadi, Ph.D. of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.
E-mail address: sajadimahbobeh@yahoo.com
What processes are involved for a request to access data/document
After receiving the email from the requester, the information will be sent within 2 to 3 business days.