The effect of foot reflexology massage on pain intensity during vascular needle insertion in hemodialysis patients
Design
Clinical trial with parallel control group, double blind, randomized, single center trial, Sample size 30 people.
Settings and conduct
Shahid Beheshti Hospital, Babol
According to the protocol, reflexology massage is performed in three weeks (once a week) for 5 minutes on the sole of the left foot in the area of the solar plexus. After the intervention, the arterial needle is inserted into the vessels near the fistula site and after one minute after being fixed, the pain intensity is measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 years and above; Minimum literacy to recognize numbers; Performing hemodialysis through an arteriovenous fistula in the left hand; At least two months have passed since the start of hemodialysis through the fistula; Absence of simultaneous pain in other parts of the body; Male gender.
Exclusion Criteria: Intolerance of pressure and massage in the area of the sole of the left foot; The presence of injury or lesion in the massage place; Death and travel.
Intervention groups
Intervention group 1: In this group, according to the protocol, reflexology massage is performed in three weeks (once a week) for 5 minutes on the sole of the left foot in the area of the solar plexus. After the intervention, the arterial needle is inserted into the vessels near the fistula site and after one minute after being fixed, the pain intensity is measured.
Intervention group 2: In this group, according to the protocol, massage is performed for 5 minutes at the opposite point of the solar plexus area on the back of the foot.
Control group: No treatment is done and only routine treatment is done. It is only for comparison with the intervention group.
Main outcome variables
Pain intensity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N74
Registration date:2022-12-24, 1401/10/03
Registration timing:prospective
Last update:2022-12-24, 1401/10/03
Update count:0
Registration date
2022-12-24, 1401/10/03
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-03-30, 1402/01/10
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 during vascular needle insertion in hemodialysis patients
Public title
The effect of foot reflexology massage on pain intensity during vascular needle insertion in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and above
Minimum literacy to recognize numbers
Performing hemodialysis through an arteriovenous fistula in the left hand
At least two months have passed since the start of hemodialysis through the fistula.
Absence of simultaneous pain in other parts of the body
Male gender
Exclusion criteria:
Intolerance of pressure and massage in the area of the sole of the left foot
The presence of injury or lesion in the massage place
Death and travel
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 4).
Using Sealed Envelope software to generate random number tables.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Outcome assessor and analyzer and participant will be blind (double blind) and will not be aware from grouping. Definition of groups A, B and C will be available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.SEMUMS.REC.1401.166
Health conditions studied
1
Description of health condition studied
Intensity of pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain intensity
Timepoint
Before and after the intervention
Method of measurement
Numeric Pain Rating Scale (NRPS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, according to the protocol, reflexology massage is performed in three weeks (once a week) for 5 minutes on the sole of the left foot in the area of the solar plexus. After the intervention, the arterial needle is inserted into the vessels near the fistula site and after one minute after being fixed, the pain intensity is measured.
Category
Treatment - Other
2
Description
Intervention group 2: In this group, according to the protocol, massage is performed for 5 minutes at the opposite point of the solar plexus area on the back of the foot.
Category
Treatment - Other
3
Description
Control group: No treatment is done and only routine treatment is done. It is only for comparison with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohammadreza Asgari
Street address
Babol, Shahid Ghasemi St
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 2071
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available