Determining the effect of reflexology foot massage on pain intensity and limb movement in patients with operated femur fracture
Design
Clinical trial with control group, with parallel groups, randomly controlled, double-blind on 112 patients
Settings and conduct
The study in the orthopedic ward of Shahid Bahonar Hospital is performed on all patients with operated femur fracture. The intervention is performed by massage for 15 minutes, 6 hours after the operation and 12 hours after the first intervention. Before the intervention, Immediately after the intervention and 2, 4, 6, 12 hours later and on the day after the operation and the day of discharge, the amount of pain and movement of the patients' limbs is measured.
Participants/Inclusion and exclusion criteria
Conscious written and oral consent
With closed femoral fracture
Spinal anesthesia surgery
Age 75-18 years
At least six hours after surgery
Awareness of place, time and person
Enjoy complete health of sight and hearing
Refer the patient to another medical center
Early clearance
Consumer of alcohol and other drugs
History of similar intervention at least three months ago
Wounds, fractures, deformities and skin disorders in the foot
Intervention groups
Intervention group: Massage protocol is performed on a healthy foot for 15 minutes, 6 hours after the operation and 12 hours after the first intervention. Control group: Lubrication of the foot without applying pressure for one minute ,6 hours after the operation and 12 hours after It is done from the first intervention.
Main outcome variables
Pain intensity; limb movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210725051985N1
Registration date:2021-08-16, 1400/05/25
Registration timing:prospective
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Yasaman Ghasempour Soleimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3214 2397
Email address
yghasempour98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-22, 1400/05/31
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on pain intensity and limb movement in patients with operated femur fracture
Public title
The effect of foot reflexology massage on patients after femur surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious written and oral consent
With closed femoral fracture
Spinal anesthesia surgery
Age 75-18 years
At least six hours after surgery
Awareness of place, time and person
Enjoy complete health of sight and hearing
Exclusion criteria:
Refer the patient to another medical center
Early clearance Consumer of alcohol and other drugs
History of similar intervention at least three months ago
Wounds, fractures, deformities and skin disorders in the foot
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done in the intervention and control group using Envelope Cards. According to the researcher, a number of envelopes containing cards are considered as the intervention group and the same number of envelopes containing cards for the control group; Then, by merging the cards together, a card is taken out and its allocation is recorded, and that card is returned to the group of other cards after being taken out. The cards are then merged again and another card is removed. This process continues until a random sequence according to the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Evaluation using visual acuity instrument (VAS) immediately and at 2, 4, 6, 12 hours after the first intervention and immediately and at 2, 4, 6, 12 hours after the second intervention until the postoperative day visit by the evaluator colleague The blind is done. The treating physician and physiotherapist (blind) will evaluate the patient's cooperation in moving the operated leg, which is related to the amount of movement, on the day after the operation and on the day of discharge, based on the limb movement evaluation checklist. In order to establish the blinding of the study, by providing the necessary explanations and relevant reasons, patients are asked not to inform anyone else about the intervention without consulting the researcher.
And the statistics analyst is also blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Hormozgan University of Medical Sciences
Street address
Vice-chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas, Hormozgan, Iran
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Approval date
2021-07-23, 1400/05/01
Ethics committee reference number
IR.HUMS.REC.1400.163
Health conditions studied
1
Description of health condition studied
Closed fracture of the femur
ICD-10 code
S72.3
ICD-10 code description
Fracture of femur
2
Description of health condition studied
Patients' pain after femur surgery
ICD-10 code
G89.18
ICD-10 code description
acute postprocedural pain
3
Description of health condition studied
Movement of patients' limbs after femur surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Visual Analog Scale (VAS) Patient Pain Score
Timepoint
immediately at 2, 4, 6, 12 hours after the first intervention and immediately at 2, 4, 6, 12 hours after the second intervention until the day after surgery
Method of measurement
This scale is a horizontal ruler that is divided from zero to 10 and measures the severity of pain. The amount of pain is measured by the researcher using the Visual-Linear Pain Scale (VAS), which is standardized for measuring pain. The Linear-Visual Pain Scale is divided from zero to ten as follows:1-3 Mild pain4-7 moderate pain8-10 Severe painThe number zero means painless and the number 10 means very severe pain.
2
Description
Rank the amount of member movement based on the checklist
Timepoint
The day after surgery and the day of patient discharge
Method of measurement
In this checklist, questions related to moving the operated organ of the patient based on the comments and examination and observation of the treating physician and physiotherapist on the day after surgery and the day of discharge in the field of pain-relaxation-movement and patient cooperation as six options from No cooperation until very well described by the sign.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive a foot reflexology massage. In this study, the researcher will place the patient in a comfortable supine position. Disinfecting and washing the feet will be done at the beginning and at the end of the work. For 15 minutes, the healthy foot will be subjected to a reflexology massage technique using baby oil, which has no therapeutic value. The researcher will sit on a chair at the bottom of the patient's bed and massage as follows: and first the soles of the feet will be gently massaged, gentle movements and gentle massage will take 1 minute from the beginning and 1 minute from the last minutes of the massage. First, in a healthy foot, according to the foot massage reflection massage protocol, some of the first ten treatment techniques in this type of massage, which is a multiple of three, will be performed.And then we will do the same stimulation and stabilization techniques in the same way. The three sensitive points, which are the solar plexus, the pituitary gland and the heart, will be under constant pressure for 2 minutes (at any point) with the thumb. The pressure is such that the upper third of the researcher's thumb turns white and the patient feels this pressure but does not feel pain. These points will first be pressed steadily for two minutes and then massaged in a circular motion.The purpose of the massage is to move the thumbs in a circular motion in a clockwise direction and continuously on the reflection points without losing contact with the skin. This technique will be done the same for all patients and also the reflex massage of the sole of the foot for women. It will be done by the researcher and for men under the direct supervision of the researcher and by a trained male research colleague.
Category
Rehabilitation
2
Description
Control group: In this group, the trained researcher and colleague place the patients in a comfortable supine position. 6 hours after the surgery and also 12 hours after the first intervention, they lubricate the foot for one minute without any pressure to achieve the effect of touch. The dependent variable (pain) should be the same in both groups and controlled. They will also stay with the patient for 15 minutes to ensure that the effect of the presence of a massager is the same for both groups (14). The measurement of the patient's pain intensity in the same hours as the intervention group is done by a blind assessor and movement evaluation is done by the treating physician and physiotherapist in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Educational and Medical Center
Full name of responsible person
Mehdi Ahmadinezhad
Street address
Gharani Street., Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
+98 34 3226 0100
Email
mehdia50@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Street address
Vice-chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas, Hormozgan, Iran
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 8583
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Yasaman Ghasempour Soleimani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gharani Street., Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
yghasempour98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hadi Yousefi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Emam Hosein Blvd., University of Medical Sciences
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3331 7723
Email
hadiyousefi17@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Yasaman Ghasempour Soleimani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gharani Street., Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
yghasempour98@gmail.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