Determining the effect of auriculotherapy on occupational stress in hospital personnel
Design
The present study will be a single-blind, randomized controlled trial with two parallel groups on 96 people. The randomization phase will be performed and demographic and occupational questionnaires will be completed. Randomization will be performed using the online site https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Settings and conduct
The present study will be a single-blind, randomized controlled trial with two parallel groups, Which will be performed at Dr. Pirouz Hospital in Lahijan. Individuals will respond to a standard job stress questionnaire. before the intervention, the job stress classification will be divided into two categories. Randomization will be performed using the online site https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least 6 months of experience working in a hospital Have completed a written informed consent form Their job stress score is moderate or sever؛ Exclusion criteria: Individuals with a history of known chronic physical or psychiatric illness Individuals have been treated with auriculotherapy within the last two months Pregnant employees
Intervention groups
Auriculotherapy will be administered once a week for 6 weeks for both intervention and control groups. stimulate the target points for 15 seconds each with the Pointer Excel II device, and then hypoallergenic seeds will be attached to the ear. IN this study, four main stress-related areas including Shenmen, Endocrine, Tranquilizer and Relaxation points will be stimulated in the non-dominant ear of the intervention group. IN the control group, stimulation and seed placement will be performed at 4 pseudo-points other than the main points and further away from the mentioned areas
Main outcome variables
Job stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241004063257N1
Registration date:2024-12-02, 1403/09/12
Registration timing:prospective
Last update:2024-12-02, 1403/09/12
Update count:0
Registration date
2024-12-02, 1403/09/12
Registrant information
Name
Morvarid Ghasab Shirazi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3260 2398
Email address
morvashirazi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-20, 1403/09/30
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Auriculotherapy on Occupational Stress in Health Personnel in Hospital: A randomized Controlled Trial
Public title
The effect of Auriculotherapy on Occupational Stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Healthcare personnel who have at least 6 months of experience working in a hospital
Have completed a written informed consent form
Their job stress score is moderate or severe
Exclusion criteria:
Individuals with a history of known chronic physical or psychiatric illness
Individuals have been treated with auriculotherapy within the last two months
Pregnant employees
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using the online site https://www.sealedenvelope.com/simple-randomiser/v1/lists. To ensure proper randomization, the resulting randomization list will be provided to an epidemiologist or other individual other than the person administering the intervention. Each time personnel come to participate in the study, they will be asked by telephone about their allocation to each of the study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants will be blinded to the intervention, while the researchers will be aware of the treatment techniques and the outcome assessor will be unaware of the type of intervention performed and will not actually know which points were stimulated.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Siadati Blvd ., Namjoo Ave
City
Rasht
Province
Guilan
Postal code
4477166595
Approval date
2024-09-25, 1403/07/04
Ethics committee reference number
IR.GUMS.REC.1403.272
Health conditions studied
1
Description of health condition studied
Job Stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Job Stress
Timepoint
Before the intervention, job stress will be assessed at the end of the third and sixth auriculotherapy sessions and 15 days after the end of treatment to assess the effectiveness of the treatment.
Method of measurement
In this study, the Persian and psychometric version of the OSIPO questionnaire will be used to assess the level of job stress.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Auriculotherapy will be performed once a week for 6 weeks for both intervention groups. The target points will be stimulated for 15 seconds each with the Pointer Excel II device and then Vaccaria seeds will be applied. Participants will be instructed to apply manual pressure to the ear points at least five times a day. In this study, four main stress-related areas including the Shen Man, Endocrine, Tranquilizer, and Relaxation points will be stimulated on the non-dominant ear in the intervention group.
Category
Rehabilitation
2
Description
Control group: stimulation and seed placement will be performed at 4 false points other than the main points and further away from the mentioned areas for the same period of time, and the same instructions as the intervention group will be given.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pirooz Hospital
Full name of responsible person
Morvarid Ghasab Shirazi
Street address
Keshavarz Blvd
City
Lahidjan
Province
Guilan
Postal code
4311144199
Phone
+98 13 4223 5503
Email
morvashirazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ramyar Farzan
Street address
Namjoo Blvd
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Morvarid Ghasab Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary medicine
Street address
Namjoo Blvd
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3334 6489
Email
morvashirazi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Morvarid Ghasab Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary medicine
Street address
Namjoo Blvd
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3334 6489
Email
morvashirazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Morvarid Ghasab Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Namjoo Blvd
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3334 6489
Email
morvashirazi@yahoo.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