Protocol summary

Study aim
Investigating the effect of auriclotherapy on the level of stress, anxiety and depression after mastectomy in women with breast cancer
Design
A controlled clinical trial with parallel groups, double-blind, randomized by random selection from the envelopes corresponding to the numbers of the test and control groups on 70 patients.
Settings and conduct
in Isfahan breast cancer clinic. the test group will be treated with auriclotherapy (Relax, Mr. Shoulder, Long 2, Anxiety, Shenman and Thalamic points) up to ten weekly sessions and then Vaccaria Seed It is placed on the corresponding points. Then, patients are advised to press the pads for one minute every hour, and at the end of the week, the points will be stimulated again and seeds will be placed again. In the control group, auriclotherapy is not performed and only Vaccaria Seed patch is placed on the desired points every week. After the intervention sessions, the questionnaires will be given to the patients in two groups again.
Participants/Inclusion and exclusion criteria
Iranian nationality Not suffering from infectious diseases and other neurological diseases At least two weeks have passed since the mastectomy Not using antidepressants Reproductive age Obtaining a score of at least 19 in the 21-question DASS questionnaire before the intervention, Absence of infection and apparent abnormality in the ear
Intervention groups
subjects in the intervention group: breast cancer patients who undergo auriclotherapy up to ten sessions weekly, and after that, Vaccaria Seed is placed on the relevant points. subjects in the control group: the breast cancer patients who do not undergo auriclotherapy, but only Vaccaria Seed path is placed on the desired points every week. And it is not recommended to press the points.
Main outcome variables
stress, anxiety and depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091219002889N13
Registration date: 2022-11-07, 1401/08/16
Registration timing: registered_while_recruiting

Last update: 2022-11-07, 1401/08/16
Update count: 0
Registration date
2022-11-07, 1401/08/16
Registrant information
Name
Mahboubeh Valiani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 4640
Email address
valiani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-26, 1401/08/04
Expected recruitment end date
2022-12-25, 1401/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of auriclotherapy on the level of stress, anxiety and depression after mastectomy in women with breast cancer
Public title
Auriclotherapy on stress, anxiety and depression after mastectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality At least two weeks have passed since the mastectomy Reproductive age Obtaining a score of at least 19 in the DASS questionnaire before intervention
Exclusion criteria:
Not suffering from infectious diseases and other neurological diseases such as MS Absence of infection and apparent abnormality in the ear Non-use of complementary medicine techniques during the last two months
Age
From 15 years old to 54 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
At this stage, the trained person provides the sealed envelopes in which intervention and control groups are registered as number one and number two, respectively and hidden , and they are randomly assigned to two intervention and control groups. They find that neither the patients were previously aware of their choice nor the researcher has any knowledge in this field.
Blinding (investigator's opinion)
Double blinded
Blinding description
The questionnaire will be distributed among the patients by another trained person and will be completed and delivered by the patients. The trained person will determine the score of the questionnaire. Then the people who have obtained a score of 19 and above from the three scales of stress, anxiety and depression of the DASS questionnaire and meet the inclusion criteria will be included in the study. At this stage, the trained person provides the sealed envelopes in which intervention and control groups are registered as number one and number two, respectively and hidden , and they are randomly assigned to two intervention and control groups. They find that neither the patients were previously aware of their choice nor the researcher has any knowledge in this field.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.202

Health conditions studied

1

Description of health condition studied
stress, anxiety and depression
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

Primary outcomes

1

Description
Score of stress, anxiety and depression in DASS questionnaire
Timepoint
Before and after intervention
Method of measurement
The depression anxiety stress scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They undergo ten weekly sessions of auriclotherapy (Relax, Mr. Shoulder, Long 2, Anxiety, Shen Man and Thalamic points) and then Vaccaria seeds is placed on the corresponding points. Then, the patients are advised to press the pads for one minute every hour, and at the end of the week, they will come back and be stimulated again and the pads will be applied.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
مراکز و کلینیک های سرطان پستان شهر اصفهان
Full name of responsible person
دکتر محبوبه والیانی
Street address
خیابان آپادانا اول ، معاونت درمان علوم پزشگی اصفهان
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3661 9661
Email
valiani@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Asgari
Street address
Hezar jereb Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isfahan University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Midwifery and Reproductive Health
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Fax
Email
valiani@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isfahan University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Midwifery and Reproductive Health
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
valiani@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Midwifery Departement, Nursing & Midwifery Faculty. IUMS
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Fax
Email
valiani@nm.mui.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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, will be published in the articles resulting from this study and the final report.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Secondary data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data will only be available for use in meta-analysis studies.
From where data/document is obtainable
To receive the data, contact the responsible person in this study via email.
What processes are involved for a request to access data/document
After sending the request from the academic person, the email will be checked and after confirming the purpose of accessing the data, the person responsible for the study will respond to the request as soon as possible.
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