Determining the effect of tuinatherapy with chamomile oil extract on the severity of back pain in operating room personnel of selected hospitals in Isfahan city in 2021
Design
This study will be conducted in the form of a randomized, double-blind, controlled clinical trial and will be divided into three groups, A.B.C.
Settings and conduct
This study was conducted in two selected hospitals where the operating room personnel of one hospital will be considered as the control group and the personnel of the other hospital will be considered as the intervention group. In the intervention group, the researcher, at the beginning of the morning shift, appeared in the operating room of the selected hospitals and after additional explanations about the work process, asked the research unit to sit on the bed and in a separate room (rest room for female personnel) ) and lie in a comfortable position on his stomach (without seeing the used oil in order to establish the condition of blinding) in the conditions of privacy.
Participants/Inclusion and exclusion criteria
Pregnancy in the last 6 months
Suffering from underlying diseases such as rheumatism and diabetes
History of back trauma
Intervention groups
Group A: Intervention group one: Tuinatherapy with liquid oil + chamomile plant oil extract Group B: Intervention group two: Tuinatherapy with only liquid oil Group C: Control group
Main outcome variables
Operating room personnel, in order to reduce or improve back pain following long standing in operating rooms, use tuinatherapy using chamomile oil extract as a low-complication drug, instead of chemical drugs with known complications. put in the agenda of their daily use.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220725055548N1
Registration date:2022-08-31, 1401/06/09
Registration timing:prospective
Last update:2022-08-31, 1401/06/09
Update count:0
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
Seyedehmaryam Seyedy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3366 1832
Email address
seyedehmaryamseyedi71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-21, 1401/06/30
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Tuina-therapy with chamomile oil extract on the intensity of low back pain in the women operating room
Public title
Evaluation of the effect of Tuina-therapy with chamomile on the intensity of low back pain in the women operating room
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Absence of cuts, wounds and scratches on the skin of the waist area
Female gender (according to the principle of conformity in medical ethics)
Having a bachelor's or associate's degree in the operating room
Playing the role of circular or scrub
Body mass index less than 30 kg/m2
Job-related back pain (based on the individual's history)
Exclusion criteria:
Age
From 25 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method was used. In this method, 3 blocks containing 35 people in each block are used, and the number of people assigned to each group is equal to 35 people. In this method, blocks are formed based on the variables in question, and half of the intervention people and half of the control people are included in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in the form of a double-blind randomized clinical trial study. Sampling will be done in an easy or accessible way; In this way, from among the people who meet the criteria for entering the study, from the time the plan is approved until the desired sample size is reached, people are entered into the study; In clearer words, among the female operating room technicians (scrub, circular) working in the operating rooms, after stating the objectives of the study and obtaining informed consent, in the order of access until reaching the target sample size (105 people), people will be included in the study. Then, people will be divided into three groups by simple random method.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2022-07-17, 1401/04/26
Ethics committee reference number
IR.ARI.MUI.REC.1401.126
Health conditions studied
1
Description of health condition studied
Back pain of female staff in the Operating room
ICD-10 code
Z68.52
ICD-10 code description
Body mass index (BMI) pediatric, 5th percentile to less than 85th percentile for age
Primary outcomes
1
Description
The score of back pain in the Visual Analogue Scale questionnaire and the percentage of people whose questionnaire score is less than 8
Timepoint
Once before the start of the intervention and once again after the end of the intervention
Method of measurement
Visual Analogue Scale standard questionnaire demographic information questionnaire
Secondary outcomes
1
Description
Back pain reduction Score.
Timepoint
Before the start of the intervention and after the end of the intervention or after 10 Massage sessions.
Method of measurement
Visual Analogue Scale questionnaire
Intervention groups
1
Description
Intervention group one: Tuina therapy with liquid oil + chamomile plant oil extract (35 people)
Category
Prevention
2
Description
Intervention group two: Tuinatherapy with only liquid oil (35 people)
Category
Placebo
3
Description
Control group: No specific intervention is performed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
AlZahra Hospital and Kashani Hospital of Isfahan
Full name of responsible person
Afsana Amini Bitraf and Habib Jalali
Street address
Isfahan Sefe Blvd AlZahra (S) Educational and Therapeutic Center and Ayatollah Kashani Street, Ayatollah Kashani Educational and Therapeutic Center, Isfahan
Hazar Jarib St Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Headquarters, Research and Technology Vice-Chancellor of the University, 1st Floor
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
technology@mui.ac.ir
Web page address
https://tech.mui.ac.ir/
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
Seyedehmaryamseyedy
Position
Surgical technologist
Latest degree
Bachelor
Other areas of specialty/work
Operating room
Street address
Velayat 8 Mashhad
City
Isfahan
Province
Isfehan
Postal code
91539968451
Phone
+98 51 3366 1832
Email
Seyedehmaryamseyedi71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedehmaryamseyedy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technologist
Street address
Hazar jarib Street Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0983136680048
Email
Seyedehmaryamseyedi71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyedehmaryamseyedy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technologist
Street address
Hazar Jarib Street Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Seyedehmaryamseyedi71@gmail.com
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