impact of foot massage (reflexology) on fatigue and pain in patients with Thalassemia
Design
This study is a randomized double-blind clinical trial, that will be done on 105 Thalassemia major patients. There are three study groups including: Intervention1(reflexology) ، intervention 2(simple touch) and control
Settings and conduct
This research will be carried out on 105 thalassemic patients at Iranshahr Special Disease center. The studied groups include foot reflexology; touch (placebo) and control groups. patients and variable evaluator (researcher assistant) have no information about patients allocation to the groups . Intervention will be done by patients themselves and assessment will be done by researcher assistant.
Participants/Inclusion and exclusion criteria
Inclusion criteria: thalassemic patients that refereed to Iranshahr Special Disease Center; age over 18 years old.
Non-inclusion criteria: specific skin disorder such as cellulite and burn at massage area; mental disorder; cognitive and mental illness.
Intervention groups
Intervention group 1: foot reflexology massage will be executed in this group of patients by themselves.
Intervention group 2 : the simple touch on sole of foot will be executed in this group of patients by themselves. Control group : no intervention.
Main outcome variables
Pain; Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190303042906N1
Registration date:2019-05-27, 1398/03/06
Registration timing:prospective
Last update:2019-05-27, 1398/03/06
Update count:0
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
Abdollah Dakkalirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3721 3897
Email address
a.dakkalirad@irshums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-04, 1398/03/14
Expected recruitment end date
2019-07-04, 1398/04/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating impact of foot reflexology massage on pain and fatigue in major thalassemic patient
Public title
Effect of foot reflexology massage in thalassemic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged over 15 years old
Exclusion criteria:
cognitive and mental disorder
skin disease such as cellulitis and burn in massage area
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization type is stratified randomization that will be done base on pain and fatigue classes (in two classes:moderate and severe). The selection of first sample will be by drawn numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients (samples) are unaware about that they are in which group (intervention 1 - intervention 2 (placebo) and control). In addition, the person who fills the questionnaire (researcher assistant) does not know that the patient is from which group (intervention1 -intervention 2 (placebo) -control).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committe of Rafsanjan University of Medical sciences
Street address
Rafsanjan University of Medical science, Imam Ali Ave
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.RUMS.REC.1397.240
Health conditions studied
1
Description of health condition studied
Major Thalasemia
ICD-10 code
D56
ICD-10 code description
Thalassemia
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention and after the intervention and two week after intervention
Method of measurement
numeric rating scale
2
Description
fatigue
Timepoint
Before the intervention and after the intervention and two week after intervention
Method of measurement
fatigue severity scale
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group1: The foot reflexology massage will be done by the patient himself on foot reflectic points for ten minutes in every other day, for two weeks.
Category
Treatment - Other
2
Description
Intervention group2 ( placebo): the simple foot touch will be done by the patient himself for ten minutes in every other day, for two weeks.
Category
Placebo
3
Description
Control group: no intrvention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranshahr Special Disease center
Full name of responsible person
Abdollah Dakkalirad
Street address
Iranshahr Special Disease center, Emam Khomaini 48 blvd.
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9916643535
Phone
+98 54 3721 3891
Fax
+98 54 3721 3308
Email
a.dakalirad@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Monavare naderi
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
info@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Iranshahr University of Medical Sciences
Full name of responsible person
عبدالله دکالی راد
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomaini 48 blvd.
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9916643535
Phone
+98 54 3721 3891
Fax
+98 54 3721 3308
Email
Irshums@irshums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ansari
Position
associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3425 8497
Email
shibonraf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Abdollah Dakkalirad
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Headquarter of Iranshahr University of Medical Sciences, Emam 48 Avenue
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9916643535
Phone
+98 54 3721 3897
Fax
+98 54 3721 3308
Email
a.dakalirad@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
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