Determining the effect of foot reflexology massage on pain and fatigue after lumbar spine surgery in patients admitted
Design
This interventional study is a randomized, clinical trial with two intervention and control groups. The data gathering tool was a demographic questionnaire and a visual analogue scale for measuring pain and fatigue in patients (from zero to 10.
Settings and conduct
After obtaining the ethics committee, the researcher visits Shaheed Beheshti Hospital. Based on the criteria for entry, the patients are divided into two groups of test and control according to the list drawn from the random numbers table, which is covered by the patient.
Participants/Inclusion and exclusion criteria
1. At least 3 months of back pain before surgery
2. Be alert at the time of research
3. Age between 35 and 60 years
4. Spinal cord stenosis in the lumbar region with moderate severity
5. Body Mass Index (BMI) Between 5/16 to 30
Intervention groups
The demographic questionnaire is completed and the severity of pain and fatigue and physiological indicators are immediately measured and recorded before intervention. Then, in the test group, the foot reflexology massage nurse after washing and greasy hands with olive oil routinely and 5 minutes on pituitary and Solar Plexus points and 10 minutes of lumbar spine points on each of the legs It will take 30 minutes to complete the massage. Immediately after massage, 60 and 90 minutes and 24 hours after massage, the severity of pain and fatigue and physiological indicators are re-measured and recorded. In the control group, after hand-fatting with olive oil, each patient's leg should be fattened at least 5 minutes each time for one minute, with approximately the amount of oil consumed equal to the intervention group.
Main outcome variables
Intensity of pain،Tiredness،Clinical signs of hypertension and respiratory depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181111041608N1
Registration date:2018-11-20, 1397/08/29
Registration timing:retrospective
Last update:2018-11-20, 1397/08/29
Update count:0
Registration date
2018-11-20, 1397/08/29
Registrant information
Name
Maryam Amirpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 1813
Email address
m.amirpoor@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-22, 1396/05/31
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2017-08-22, 1396/05/31
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
2018-02-19, 1396/11/30
Scientific title
The effect of foot reflexology massage on pain and fatigue after lumbar spine surgery
Public title
Determining the effect of foot reflexology massage on pain and fatigue after lumbar spine surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. At least 3 months of back pain before surgery2. Be alert at the time of research3. Age between 35 and 60 years4. Spinal cord stenosis in the lumbar region with moderate severity5. Body Mass Index (BMI) Between 5/16 to 30
Exclusion criteria:
1. No tolerance 2. Anesthesia in the legs 3. Vascular disorders of the lower limbs 4. Lower limb flexion 5. Drug Addiction and Substance Abuse 6. Get Pain Pump By Self Patient 7. Rupture of Intervertebral Disk 8. Stroke of Spinal Cord
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
After easy sampling of qualified individuals and completion of informed written consent, samples are divided into two groups of test and control according to the list drawn from the random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were divided into two groups of test and control. They were explained to the patients themselves (both groups). Data was collected at all stages by an unknowing nurse of the group.
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Shahid Sadoughi University of Medical Sciences Yazd
Street address
Yasuj shahid motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.SSU.REC.1395.239
Health conditions studied
1
Description of health condition studied
Spinal Surgery
ICD-10 code
G55.1
ICD-10 code description
G55.1
Primary outcomes
1
Description
PAIN
Timepoint
Post-interventional pain (30 minutes for control group), 60 minutes after intervention, 90 minutes after intervention, 24 hours after intervention
Method of measurement
Standard Scale -New
2
Description
Fatigue
Timepoint
Post-interventional pain (30 minutes for control group), 60 minutes after intervention, 90 minutes after intervention, 24 hours after intervention
Method of measurement
Standard Scale -New
3
Description
Signs of blood pressure and respiratory and pulse
Timepoint
Post-interventional pain (30 minutes for control group), 60 minutes after intervention, 90 minutes after intervention, 24 hours after intervention
Method of measurement
Pulse measurements are measured by touching the pulse position and the counting and inhalation by measuring and observing the pressure measurement device.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the researcher thoroughly washes his hands with warm water and smears with olive oil and massage together to slip through the warmth of the hands to ease the reflex massage. The patient is placed in the back rest position and, while foot massage, is supported by a pillow below it, and placed higher and removed after the massage of the pillow. After relaxing techniques for 5 minutes, the pituitary reflexes, Solar Plexus points, the spinal reflex points are massage for 10 minutes. The total massage time is 30 minutes (15 minutes each).
Category
Other
2
Description
Control group: In the control group, the researcher at the time corresponding to the test group, twice in 5 minutes intervals, and at least once for a minute, without any compression, lubricates the points on both sides of the patient.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Maryam Amirpoor
Street address
Kohgiluyeh and Boyer-Ahmad Province, Yasuj, Montazeri St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Email
m.amirpoor@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzaei
Street address
Yazd Bahonar Square, Shahid Sadoughi University of Medical Sciences and Health Services Yazd, Third Floor
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2248
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Amirpoor
Position
Senior Care Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yasuj Shahid Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Email
m.amirpoor@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mostafa Javadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yazd - Safaiyeh - Bou-Ali Boulevard - Nursing and midwifery department
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 1824 1751
Email
javadi@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Amirpoor
Position
Senior Care Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
motahhari sd.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3323 4722
Email
m.amirpoor@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Data results are published
When the data will become available and for how long
Three months after completion
To whom data/document is available
For scholars working in academia and academia
Under which criteria data/document could be used
by Email
From where data/document is obtainable
With the author of the article
What processes are involved for a request to access data/document