Protocol summary

Study aim
Determine The Effect of concomitant Exercise and Aromatherapy On The Fatigue Severity Of the Surgical Technologists.
Design
The researcher will collect samples by referring to the departments in three shifts, and the surgical technologists of orthopedic, general surgery, neurosurgeon and cardiopulmonary surgery who are moderate or severe in the group of fatigue based on the MFI fatigue scale. A simple random case will be selected for intervention. For estimation of sample size Based on the previous study, the sample size in each group was estimated to be 33.
Settings and conduct
This is a single-blind study (participants) that will be conducted on Tabriz hospitals surgical Technologists who have moderate or severe fatigue.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The informed consent of the participant, Having at least one year of work experience in the operating room, Not having history of accidents and life crisis in the last 6 months, Not having regular professional exercise program, No ban on exercise, Healthy olfactory sense of the participant and No respiratory disease, such as asthma, allergy and... .
Intervention groups
In the exercise group, a exercise program that includes concomitant exercises will be used. After explaining how to practice exercises in person, a brochure on how to do the exercises will be provided to surgical technologists until once in each shift and for 10 For at least 15 minutes.In the lavender group, the lavender necklace containing the lavender essence is studied in such a way that the container of cotton content is stained with 3 drops of lavender oil at the front and 20 cm in the chest, will be used for one hour per shift and at activity time . And in the control group, no intervention will be used.
Main outcome variables
Fatigue score before the intervention, and in the first, second, third, and fourth weeks after intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180807040736N1
Registration date: 2019-03-16, 1397/12/25
Registration timing: registered_while_recruiting

Last update: 2019-03-16, 1397/12/25
Update count: 0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Omid Zadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3243 2043
Email address
omid.zd.axule73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of concomitant exercise and Aromatherapy on the Fatigue severity of Surgical Technologists.
Public title
Effect of concomitant exercise and aromatherapy on fatigue severity of surgical technologists
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The informed consent of the participant. Having at least one year of work experience in the operating room. Not having history of accidents and life crisis in the last 6 months. Not having regular professional exercise program. No ban on exercise. Healthy olfactory sense of the participant No respiratory disease, such as asthma, allergy and...
Exclusion criteria:
Desire to leave the study Crisis or unexpected incident during an intervention such as leave and sick leave An unpleasant feeling of lavender essence
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 99
More than 1 sample in each individual
Number of samples in each individual: 5
1: before intervention, 2:1 week after intervention, 3: 2 weeks after interventions, 4: 3week after intervention, 5: 4 weeks after intervention
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single blinded , so that surgical technologists are unaware of the existence of another group, and the statistics analyst will be unaware of the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Qezel dash Alley, Ostad Shahriar Ave, Akhoule town, Khosrowshah, Tabriz
City
Tabriz_Khosrowshah
Province
East Azarbaijan
Postal code
5356145514
Approval date
2019-01-02, 1397/10/12
Ethics committee reference number
IR.MAZUMS.REC.1397.363

Health conditions studied

1

Description of health condition studied
Chronic Fatigue
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fatigue
Timepoint
Before intervention, 1 week after intervention, 2 weeks after intervention, 3 weeks after intervention, 4 weeks after intervention.
Method of measurement
Multidimensional Fatigue inventory questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: concomitant exercise involves stretching and strength exercises that can be performed in standing and sitting positions and suitable for surgical technologists. First, how to do the exercises will be explained to the participant, and then they will be given a pamphlet describing how the exercises are performed. They can do it once per shift and for 10 to 15 minutes..
Category
Treatment - Other

2

Description
Intervention group: Aromatherapy with lavender 2%
Category
Treatment - Other

3

Description
Control group: without intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Omid Zadi
Street address
Golgasht, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5356145514
Phone
+98 41 3243 2501
Email
Omid.zd.axule73@gmail.com

2

Recruitment center
Name of recruitment center
Tabriz Shohada Hospital
Full name of responsible person
Omid zadi
Street address
Golshahr Ave, Shohada Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5356145514
Phone
+98 41 3243 2501
Email
Omid.zd.axule73@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi
Street address
Research deputy of Mazandaran University of medical science,Moallem Square, Sari
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Fax
+98 11 3336 2569
Email
enasiri@mazums.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
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Omid Zadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gizil Dash, Ostad Shahriar Ave, Akhoule, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5356145514
Phone
+98 41 3243 2043
Email
Omid.zd.axule73@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Allied Medicine Faculty of Mazandaran University, Khazar square, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 911 151 7836
Email
Rezanf2002@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Allied Medicine Faculty of Mazandaran University, Khazar square, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 911 151 7836
Email
Rezanf2002@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
The information of the participants is confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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