Comparative Investigation Between The Effectiveness Of Auriculotherapy And Counselling On Coping And Mental Adjustment To Cancer(MAC) In Women With Breast Cancer Undergoing Chemotherapy
Determining and comparing the effect of auriculotherapy and counseling on coping and mental adjustment to cancer in women with breast cancer undergoing chemotherapy
Design
A randomized, controlled, clinical trial With parallel groups, On 105 patients. Use Random Sequence Generation Online Software.
Settings and conduct
After receiving permission to conduct the research and presenting it to Kerman University of Medical Sciences, the researcher refers to the Office of Adult Blood and Oncology and affiliated centers of Kerman University of Medical Sciences and this clinical trial study will be by random sampling. The list of women with breast cancer under the supervision of selected hematologists and oncologists in Kerman will be obtained through their information registration system.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years; having written consent to participate in the study; no substance abuse; literacy; women with breast cancer undergoing chemotherapy at least one month after the start of treatment; stage 1-3 breast cancer; No severe mental disorders based on interview; no lesion or skin problem in the ear area and auriculotherapy site
Exclusion criteria:
Metastatic patients; substance abuse; use of auriculotherapy technique or any other complementary and alternative medicine during two Last month; participating in a mindfulness-based cancer recovery program or mindfulness-based stress reduction for the past five years; corona
Intervention groups
In the counseling group, eight 90-minute weekly group sessions of counseling are performed by mindfulness-based cancer recovery method. In the auriculotherapy group, two sessions per week and a total of 10 sessions of auriculotherapy will be held. The control group receives their routine medical care.
Main outcome variables
Coping , Mental Adjustment To Cancer .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201027049164N1
Registration date:2021-08-16, 1400/05/25
Registration timing:prospective
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Masumeh Ghazanfarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5856
Email address
m.ghazanfarpour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Investigation Between The Effectiveness Of Auriculotherapy And Counselling On Coping And Mental Adjustment To Cancer(MAC) In Women With Breast Cancer Undergoing Chemotherapy
Public title
Comparative Investigation Between The Effectiveness Of Auriculotherapy And Counselling On Coping And Mental Adjustment To Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Having written consent to participate in the study
No substance abuse
Literacy
Women with breast cancer undergoing chemotherapy at least one month after the start of treatment
Stage 1-3 Breast cancer
No severe mental disorders based on the interview
No lesion or skin problem in the ear area and auriculotherapy site
Exclusion criteria:
Metastatic patients
Lack of cooperation of authorities and lack of answers to questionnaire questions
Drug abuse
Participate in psychological classes simultaneously
Use of auriculotherapy technique or any other complementary and alternative medicine during the last two months
Participate in a mindfulness-based cancer recovery program or mindfulness-based stress reduction for the past five years
Application of another complementary medicine method along with auriculotherapy method
Corona
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the selection will be assigned to participants from 1 to 105, respectively. Then, using the online software for generating random sequences (www.randomizer.org) and the method of block random allocation with six blocks, people will be divided into three groups of 35 and in each of the three groups counseling, auriculotherapy and control will be placed
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
Deputy of Research and Technology;ebne-e-Sina St.,Jahad Blvd., Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2021-07-28, 1400/05/06
Ethics committee reference number
IR.KMU.REC.1400.246
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
coping With Cancer
Timepoint
At the beginning (Before starting the intervention) , Immediately upon completion of the intervention , Two months after the end of the intervention
Method of measurement
Carver Short Coping Questionnaire (Brief cope)
2
Description
Mental Adjustment To cancer
Timepoint
At the beginning (Before starting the intervention) , Immediately upon completion of the intervention , Two months after the end of the intervention
Method of measurement
Mental Adjustment To Cancer Questionnaire (MINI MAC)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the counseling group, eight 90-minute weekly group sessions of counseling are performed by mindfulness-based cancer recovery(MBCR) method
Category
Other
2
Description
Second intervention group: In the auriculotherapy group, two sessions per week and a total of ten sessions in the shen men, kidney, relaxation and lung points in the left ear and thalamic points, Mr. sholder, liver, anxiety, cerebral in the right ear using a hand probe for 15 seconds will be done and then Vacaria seed It is pasted in places. The patient is advised to press the seed three times a day for one minute, except at bedtime. On the third day, the seeds will return slowly and after stimulation, the seeds will be reattached.
Category
Other
3
Description
Control group: The control group receives routine care (care provided by the treating physician and nurses, such as prescribing and injecting chemotherapy drugs at the clinic or hospital, and recommendations and care after injection)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of a doctor specializing in blood and cancer
Full name of responsible person
Hediyeh Barkhordari
Street address
No. 3 , Saadi Ave , Mehrad Building
City
Kerman
Province
Kerman
Postal code
7613733631
Phone
+98 34 3226 5003
Email
hdi.br00@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Tahmasbabad cross road, Vice Chancellor for Research and Technology building
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
h.barkhordari@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Hediyeh Barkhordari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
h.barkhordari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masumeh Ghazanfarpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
M.ghazanfarpour@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hediyeh Barkhordari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Beginning of the axis of seven Alavi Gardens, Campus of the University of Medical Sciences, Faculty of Nursing and Midwifery
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
h.barkhordari@kmu.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