Determining the effect of foot reflexology on the shoulder, neck and waist pains as well as refreshment of the nurses.
Design
Clinical trial with a control group, one-blinded, randomized
Settings and conduct
Nurses of the Shahid Niaky hospital of Ahwaz city are considered the intervention group and nurses of the 580 hospital of Dezful city as the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1- should not be athlete.
2 - BMI should be between 18 and 25 .
3- The mean age should be between 20 and 50 years.
Intervention groups
The study of the effect of foot reflexology on the shoulder, neck and waist pains as well as refreshment of the nurses.
Main outcome variables
Pain intensity , Fatigue intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180911041006N1
Registration date:2019-01-22, 1397/11/02
Registration timing:retrospective
Last update:2019-01-22, 1397/11/02
Update count:0
Registration date
2019-01-22, 1397/11/02
Registrant information
Name
Hojatolah Mirzaeenia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 2889
Email address
mirzaeenia.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-10, 1397/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of foot reflexology on the shoulder, neck and waist pains as well as refreshment of the nurses.
Public title
The effect of the foot reflexology on the pain and fatigue of nurses.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI should be between 18 and 25.
Should not be athlete.
Age range should be between 20 to 50 years.
The nursing staff suffering from backache as well as shoulder and neck pain.
Nursing staff with fatigue.
Exclusion criteria:
Having a foot ulcer.
Having peripheral neuropathy.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Room 4 ,Ground Floor , deputy of Research and Technology Dvelopment of ahwaz Jundishapur University of Medical Sciences , University of Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-06-08, 1397/03/18
Ethics committee reference number
IR.AJUMS.SER.1397.214
Health conditions studied
1
Description of health condition studied
Skeletal and muscular pain and fatigue
ICD-10 code
M63
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
The backache intensity
Timepoint
Before the intervention and ten days after that.
Method of measurement
The visual analogue scale
2
Description
The fatigue intensity
Timepoint
Before the intervention and ten days after that.
Method of measurement
Fatigue questionnaire sofi -20
3
Description
The neck pain intensity.
Timepoint
Before the intervention and ten days after that.
Method of measurement
Visual Analogue Scale
4
Description
The shoulder pain intensity.
Timepoint
Before the intervention and ten days after that.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
quality of life
Timepoint
Before the intervention and one month after the end of the intervention
Method of measurement
SF-36 Questionnaire
Intervention groups
1
Description
Intervention group: For the intervention group, according to the location of pain, a 9-sessions foot reflexology protocol have been applied on the test group by the contributing researcher (after passing the training and acquiring skills) under supervision of the physiotherapist (for 3 weeks and 3 sessions per 30 minutes each week). The reflexology process will be such that the study unit is asked to lie on the examination bed in a quiet and bright room, close its eyes and place in a completely relaxed position. Then, after mild foot massage, the heel of the left foot would be kept pressed and bend it to the right and directly pressed (the point affecting the fatigue) with a thumb on the solar grid (Solar Plexus). Then, the massager get the patient's leg with One hand and by use of thumb of another hand, apply pressure on the reflex points of the waist, spine, ankle or any organ that is based on the Nordic questionnaire for the pain. By the individual, the alternating wave forms and smokes come in and out. This will be done within 30 minutes for both legs. Then they were asked to use fluids for 24-48 hours after each session. It should be noted that the reflexology of the female nurses is carried out by the implementer and under the supervision of a specialist physiotherapist for the protection of the Islamic components by a collaborator and in a closed environment, and reflexology of the men. control group:
Category
Rehabilitation
2
Description
Control group: In the control group, no intervention will be performed and they will only with the experimental group before and after the intervention, the Nordic and VAS questionnaires and the checklist of
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid niaky hospital
Full name of responsible person
Hojat Alah Mirzaeenia
Street address
Lashkar St , Blvd. Ghods , next to the mosque of Amiralmomenin , Shahid niaky hospital
City
Ahvaz
Province
Khouzestan
Postal code
6154633157
Phone
+98 61 3373 1165
Fax
+98 61 3333 9633
Email
mirzaeenia.h@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Dezful Army 580 Hospital
Full name of responsible person
Hojat Alah Mirzaeenia
Street address
Dezful , Army 580 Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6133645641
Phone
+98 61 3373 1165
Fax
+98 61 3333 9633
Email
mirzaeenia.h@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology .
Street address
Ground floor , Ahvaz University of Medical Sciences Jundishapur Health Services , Univercity of Ahvaz , Assistant Professor of Research and Technology
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3333 9633
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hojat Alah Mirzaeenia
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kianpars St , 1 st square , next to the fire department , Ashoori Alley , No . 81
City
Ahvaz
Province
Khouzestan
Postal code
6133645641
Phone
+98 61 3336 2889
Fax
+98 61 3333 9633
Email
mirzaeenia.h@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hojat Alah Mirzaeenia
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kianpars St , 1 st square , next to the fire department , Ashoori Alley , No . 81
City
Ahvaz
Province
Khouzestan
Postal code
6133645641
Phone
+98 61 3336 2889
Fax
+98 61 3333 9633
Email
mirzaeenia.h@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
hojat alah mirzaee nia
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kianpars St , 1 st square , next to the fire department , Ashoori Alley , No . 81
City
Ahvaz
Province
Khouzestan
Postal code
6133645641
Phone
+98 61 3336 2889
Fax
+98 61 3333 9633
Email
mirzaeenia.h@ajums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
ِdata of Pain intensity and fatigue severity
When the data will become available and for how long
Summer of 1398
To whom data/document is available
only researchers
Under which criteria data/document could be used
Researchers after obtaining permission from the research team
From where data/document is obtainable
Hojatollah Mirzaeenia
What processes are involved for a request to access data/document
Accept permission by email and related explanations regarding how to use the data