objectives:
The aim of the study was to identify the effect of thermal
therapy with FIR in comparison with non-thermal therapy on
uremic pruritus and Assessment of quality of life.
Design & setting :
A non- randomized, one-blind, controlled trial was performed
and the data were collected in 2017.
Participants including major eligibility criteria: At least 18 years of age; Ability to communicate in Persian; Diagnosis of uremic pruritus approved by the physician. Exit criterias : Any skin disease; vascular and malignant disorders.
Samples size:In each group,20 people and a total of 40 people.
The intervention:
A system for thermal therapy was used for this study. A quiet and warm room with a far-infrared ray device was used and participants were placed in a supine position on a bed for 15 minutes and kept warm by being wrapped in a blanket. Those in the thermal therapy group were treated with 40C thermal therapy with FIR. A constant temperature of 40C FIR may allow multiple energy transfer into subcutaneous tissue without irritating or overheating the skin.Thermal therapy was performed once a day for 15 minutes on two days a week for a total of 18 sessions. The participants remained on bed rest with the blanket for an additional 30 minutes after the thermal therapy in each session.Control group: The non-thermal therapy group received drug therapy and routine care. The principal investigator stayed with these patients for the same duration as the thermal therapy group.Main outcome measure(variable): uremic pruritus and quality of life in patients undergoing hemodialysis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041333245N2
Registration date:2017-10-17, 1396/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Hamed zare
Name of organization / entity
Shahed university
Country
Iran (Islamic Republic of)
Phone
+98 35 3281 4277
Email address
h.zare@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Shahed University;Elderly Research Center of Shahed University
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of thermal therapy on uremic pruritus and quality of life in patients undergoing hemodialysis
Public title
The effect of thermal therapy on uremic pruritus and quality of life in patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were:
≥18 years of age; able to communicate in persian; a diagnosis of uremia, confirmed in writing by the primary care physician; receiving haemodialysis three times a week for at least three months; having pruritus symptoms; being fully conscious. participants were excluded if they had any dermatological disorders; haematological disorders; organic problems or current use of drugs that might contradict or interfere with the assessments of outcomes; current requirement for haemodialysis more than three times per week due to comorbidity; Individuals who were unable or unwilling to follow the thermal therapy protocol for any reason were excluded from the trial
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee ofShahed University
Street address
Shahed University, Facing Imam Khomeini's holy shrine,Persian Gulf Highway, Tehran
City
Tehran
Postal code
3319118651
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.Shahed.REC.1395.195
Health conditions studied
1
Description of health condition studied
uremic pruritus
ICD-10 code
L80-L99
ICD-10 code description
Other disorders of the skin and subcutaneous tissue
Primary outcomes
1
Description
uremic pruritus
Timepoint
Pre-Test:Before the intervention;Mid-Test:After 1 month from the beginning of the intervention.Post-Test:After two months and 18 sessions of heat therapy.
Method of measurement
location and severity of uremic pruritus assessed by questionnaire and a visual analogue scale (VAS).
Secondary outcomes
1
Description
life quality
Timepoint
Pre-Test:Before the intervention;Mid-Test:After 1 month from the beginning of the intervention.Post-Test:After two months and 18 sessions of heat therapy.
Method of measurement
Assesed byquestionnaire(KDQOL- SF)Quality of life for patients with ESRD(Itchy Qol)
2
Description
biochemical indicators
Timepoint
Before thermal therapy 1 (pre-test), and middle thermal therapy 2 (mid-test),After thermal therapy 3 (post-test) months
Method of measurement
Secondary outcome measures included several biochemical indicators
Intervention groups
1
Description
Control group: The non-thermal therapy group received drug therapy and routine care. The principal investigator stayed with these patients for the same duration as the thermal therapy group.
Category
Treatment - Other
2
Description
The intervention:
A system for thermal therapy was used for this study. A quiet and warm room with a far-infrared ray device was used and participants were placed in a supine position on a bed for 15 minutes and kept warm by being wrapped in a blanket. Those in the thermal therapy group were treated with 40C thermal therapy with FIR. A constant temperature of 40C FIR may allow multiple energy transfer into subcutaneous tissue without irritating or overheating the skin.Thermal therapy was performed once a day for 15 minutes on two days a week for a total of 18 sessions. The participants remained on bed rest with the blanket for an additional 30 minutes after the thermal therapy in each session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis ward of shahid sadooghi hospital of yazd
Full name of responsible person
hamed zare
Street address
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology of Shahed University;Elderly Research Center of Shahed University
Full name of responsible person
Dr.Majideh Heravi karimavi
Street address
Shahed University, Facing Imam Khomeini's holy shrine,Persian Gulf Highway, Tehran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Shahed University;Elderly Research Center of Shahed University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
shahed university
Full name of responsible person
Hamedzare
Position
Master of intensive care
Other areas of specialty/work
Street address
Khatam-Alnbia Hospitol, imam Ali Blvd, Abarkooh
City
Abarkooh
Postal code
8934113731
Phone
+353 28 14277
Fax
Email
zare69.hz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Hamed Zare
Position
Master of Intensive care
Other areas of specialty/work
Street address
Khatamalnbia hospitol, Imam ali Blvd, abarkooh
City
abarkooh
Postal code
8934113731
Phone
+353 28 14277
Fax
Email
zare69.hz@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Hamed zare
Position
Other areas of specialty/work
Street address
City
Postal code
8934113731
Phone
00
Fax
Email
zare69.hz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)