Determining the Effect of Auriculotherapy on Stress, anxiety and depression among Nursing Staff i n Alzahra hospital of Isfahan
Design
The present study is a single-blind randomized controlled clinical trial . 56 nurses working in Al-Zahra Hospital who have the criteria to enter the research and want to participate in the research are the research samples. Samples with inclusion criteria are selected by the Convenience Sampling. in order to be randomly assigned by the number card method in a closed envelope, they will be placed in two intervention and control groups.
Settings and conduct
After obtaining the necessary permits, informed consent, sampling and random allocation in Al-Zahra Hospital in Isfahan, the DASS-21 stress-anxiety-depression questionnaire will be completed before and immediately and 4 weeks after the intervention in both groups. Data collection and data entry will be analyzed using SPSS software version 19 and statistical tests of t-test, paired t-test and one-way analysis of variance.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 6 months of experience in the hospital, No history of psychological disorders and no use of anti-anxiety, anti-depressant and sedative drugs, not addict, no allergic reaction to the adhesives in the ear
Intervention groups
The intervention in the intervention group will be done by placing adhesives containing seed (Vakaria seeds) on the areas related to stress, anxiety and depression on the ear for 8 sessions over 4 weeks. In the control group, the same intervention will be performed with non-sided adhesives on areas related to stress, anxiety and depression on the ear for 8 sessions over 4 weeks.
Main outcome variables
stress, anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200622047884N1
Registration date:2020-11-01, 1399/08/11
Registration timing:prospective
Last update:2020-11-01, 1399/08/11
Update count:0
Registration date
2020-11-01, 1399/08/11
Registrant information
Name
Narges Kheirollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7539
Email address
nargeskheirollahi92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Auriculotherapy on nurses' stress, anxiety and depression
Public title
The Effect of Auriculotherapy on Stress, anxiety and depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months of experience in the hospital
No history of Psychological disorders and no history of using anti-anxiety, anti-depressant and sedative drugs
Not addicted
Exclusion criteria:
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate randomly, a simple random method with a number card in a sealed envelope will be used. In this way, 56 cards (in order to have equal chances for research samples, 28 cards with number 1, for the control group and 28 cards with number 2 and for the control group) will be placed in the box. Participants are asked to remove a card from the envelope. Card number one will be placed in the intervention group and card number two will be placed in the control group. In order to create an equal chance for all samples, each card will be returned to the box after being removed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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
Hezar Jerib street, Isfahan, Iran 8174673461
City
Isfahan
Province
Isfehan
Postal code
کد پستی : 8174673461
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.060
Health conditions studied
1
Description of health condition studied
stress,anxiety and depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress
Timepoint
Before the intervention, immediately after the end of 8 intervention sessions and 4 weeks after the end of the intervention
Method of measurement
Stress-Anxiety-Depression Inventory DASS-21
2
Description
Anxiety
Timepoint
Before the intervention, immediately after the end of 8 intervention sessions and 4 weeks after the end of the intervention
Method of measurement
Stress-Anxiety-Depression Inventory DASS-21
3
Description
Depression
Timepoint
Before the intervention, immediately after the end of 8 intervention sessions and 4 weeks after the end of the intervention
Method of measurement
Stress-Anxiety-Depression Inventory DASS-21
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention in the intervention group will be done by placing adhesives containing Seed (Vakaria seeds) on the points related to stress, anxiety and depression on the ear for 8 sessions over 4 weeks.
Category
Treatment - Other
2
Description
Control group: In the control group, the intervention will be performed with non-seeded adhesives on the points related to stress, anxiety and depression on the ear for 8 sessions over 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Educational and Medical Center in Isfahan
Full name of responsible person
Fateme bastani
Street address
Soffeh Blvd., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7539
Email
nargeskheirollahi92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar Jerib street, Isfahan,
City
Isfahan
Province
Isfehan
Postal code
Iran 8174673461
Phone
+98 31 3792 3071
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellery for Research and Technology, Isfahan medical science university
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
Narges Kheirollahi
Position
Faculty member of Isfahan School of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7539
Email
nargeskheirollahi92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
complementary medicine
Street address
Hezar Jerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7539
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
Narges kheirollahi
Position
Faculty member of Isfahan School of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib street, Isfahan
City
Isafahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7539
Email
nargeskheirollahi92@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"No more information"
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
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
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
The results of completing the stress, anxiety and depression questionnaire before and after the intervention will be published in the form of an article without mentioning the names of the participants.
When the data will become available and for how long
from 2020
To whom data/document is available
researcher
Under which criteria data/document could be used
For use in research activities
From where data/document is obtainable
Send email to the responsible researcher
What processes are involved for a request to access data/document
Review by the responsible author and obtain permission from the Research Center