Effect of gentle exercises and foot reflexology massage on pain after spinal surgery
Design
This study was a randomized clinical trial with a control group with parallel, one-blind, randomized groups. Patients were entered on the basis of inclusion criteria and are randomly assigned to the control or intervention group 1 and 2 using closed envelopes
Settings and conduct
Patients undergoing thoracic and lumbar spine surgery according to entry criteria are randomly divided into two intervention groups and one control group. The day before surgery, the demographic and medical characteristics of the patient were completed and pain intensity was recorded using the visual scale of the pain. Intervention in group 1 on the day after surgery is reflexology massage of the foot of the foot that continues after discharge three times a week for 6 weeks. In group 2, tensile training begins on the day after surgery, which is performed in the lining or sitting room for half an hour during the hospitalization period and 3 times a week for 6 weeks in the discharge period. In the control group, only routine medications and care are performed. The severity of pain in patients was measured and recorded in all three groups before surgery, the first day after surgery, discharge time and then one week and six weeks later using the visual scale.
Participants/Inclusion and exclusion criteria
-Aged 65-18 years old
- Complete lack of sensory and motor impairment in the lower extremities
- Nervous musculoskeletal disorders
- No scarring, fractures and skin disorders in the legs
- No alcohol and other drugs
- No limitation of movement in the foot
- Failure to develop malignant diseases
Intervention groups
Group 1: Soft stretching exercises
Group 2: Foot reflexology
Main outcome variables
Study of the severity of pain in the lower limbs and the back in patients ,after spinal surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039194N1
Registration date:2018-08-19, 1397/05/28
Registration timing:registered_while_recruiting
Last update:2018-08-19, 1397/05/28
Update count:0
Registration date
2018-08-19, 1397/05/28
Registrant information
Name
Ommolbanin Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3341 9914
Email address
rostamio1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of gentle stretching exercises and foot reflexology massage on the pain of patients after spinal surgery
Public title
Study of the effect of gentle stretching exercises and foot reflexology massage on the pain of patients after spinal surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with thoracic and lumbar spine surgery
Complete lack of sensory and motor impairment in the lower extremities of patients who have had spine surgery
Satisfaction with co-operation during admission and continuation at home
Lack of inflammatory and vascular diseases, such as arthritis and vascular thrombosis
Absence of musculoskeletal disorders
Lack of ulcers, fractures and skin disorders in the legs
Lack of alcohol and other drugs
Lack of limb movement in the lower extremity
Not pregnant
Non-malignant diseases
Being trained or accompanying
Age of 16-70 years
Exclusion criteria:
Lack of spinal surgery
Sensory and motor disorder, complete or incomplete in lower limbs
Any wounds in the foot
Incompetent the patient or accompany of her or him
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Assigned with random spss numbers, in intervention or control groups,randomly
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who have spinal surgery have undergone surgery or intervention according to entry criteria and randomly in the control group or intervention group 1 or 2. Patients in each group are unaware of being in the intervention or control group. However, in each group patients are told about routine or intervention (reflexology or stretching exercises) and they will intervene in case of written consent.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
regional research ethics committee Mashhad University of Medical Sciences
Severity of pain after surgery of the thoracic sphincter and lumbar spine
ICD-10 code
G54
ICD-10 code description
Nerve root and plexus disorders
Primary outcomes
1
Description
Severity of pain after surgery of the thoracic sphincter and lumbar spine
Timepoint
Measuring the severity of pain in patients using the visual scale of pain in the day before surgery, the day after surgery, one week and 6 weeks after surgery in person or through telephone follow up or patient referral to the clinic of the studied hospitals
Method of measurement
Measuring the pain intensity of patients using the visual scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The intervention is performed as a reflexology massage on the sole of the palm, with the thumb, on the inner curvature of the floor of both legs, the alternating to the wave and smoke, and in the reciprocation of about 10 -7 minutes per foot. This intervention is performed at least once a day, 3 times a week and for 6 weeks.
Qa'im Hospital, Dr Ali Shariati Square, Beginning at Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Fax
+98 51 3845 3239
Email
Quaem.Medical.Center@mums.ac.ir
Web page address
http://quaem.mums.ac.ir/
3
Recruitment center
Name of recruitment center
Hasheminejad hospital
Full name of responsible person
Mahmood Bakhshi
Street address
Mashhad, Shahid Mofatheh-end of Abu Ravihan Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
913791336
Phone
+98 51 3273 7015
Fax
+98 51 3272 2322
Email
hasheminejad@mums.ac.ir
Web page address
http://hasheminejad.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Faculty of Nursing and Midwifery,Ebne Sina Ave.,Doktora Intersection, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3854 3031
Fax
+98 51 3859 7313
Email
Bakhshim@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ommolbanin Rostami
Position
Senior of Surgical Medical Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery,Ebne Sina Ave.,Doktora Intersection, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9166987
Phone
+98 51 3341 9914
Fax
+98 51 3859 7313
Email
rostamio1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ommolbanin Rostami
Position
Master of nursing|(medical,surgical)
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No,22,Hedayat 5 Ave.,Fadaeiyan 18 Blvd.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3341 9914
Fax
+98 51 3859 7313
Email
rostamio1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ommolbanin Rostami
Position
Senior of Surgical Medical Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery,Ebne Sina Ave.,Doktora Intersection, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9166987
Phone
+98 51 3341 9914
Fax
+98 51 3859 7313
Email
rostamio1@mums.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of mild stretching exercises and foot reflexology massage on the severity of pain in the lower and lower extremities in patients undergoing thoracic and lumbar spine surgery. The results of this research are shared among other researchers in this regard.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers and patients candidate for spinal surgery
Under which criteria data/document could be used
Data analysis will be done using descriptive and inferential statistics. After collecting data and encoding and logging into the computer, spss 11 will be used for analysis. To describe the data, the frequency distribution table (for qualitative variables) and the mean and standard deviation (for quantitative variables) will be used. In the analytical statistics, first, a quantitative quantitative test of normal values using Kolmogorov-Smynov and Shapiro Wilk tests. To determine the homogeneity of data in three groups, the Chi-square or Fisher test for qualitative variables and the Kruskal-Wallis test will be used for quantitative variables in case of normalization. Also, intra-group comparisons will be used based on whether data are normal or not. Friedman test variance analysis will be used. To determine the relationship between underlying and intervention variables, three groups of two-way ANOVA tests will be used. For all tests, the confidence coefficient will be 95%.
From where data/document is obtainable
Faculty of Nursing and Midwifery, Ibn Sina Avenue,Doktora st.Mashhad, Iran
Phone:0098 5138591511
Fax: 0098 5138597313
Zip Code: 9137913199
E-mail: NMS.IT@mums.ac.ir
What processes are involved for a request to access data/document
Referring to the library of Mashhad Nursing and Midwifery Faculty and presenting the identification card to this unit and receiving the existing documentation.