Protocol summary

Summary
The present study was conducted with the aim to determine and compare the effects of topical application of menthol and rosemary on musculoskeletal pain in hemodialysis patients. The present single-blind clinical trial recruited 105 eligible patients undergoing hemodialysis in selected hospitals affiliated to Isfahan University of Medical Sciences selected by convenient sampling. Inclution criteria is include: , Age between18-65 years, hemodialysis three times a week, Not addiction, 3 months after initiation of dialysis, severity of Pain in the lower extremities at least 4, Non-transplant candidates during the study, Full alert, Haveing the ability to communicate verbally, Not having legs vascular access, No injury to the skin at the site of drug use. Exclusion criteria include: the patients who do not like to continue to participate in the study, hospitalization during the study. The samples were divided randomly using random numbers table into three groups: consumer rosemary, menthol and placebo. Participants' severity of pain recorded prior to intervention in the questionnaire. All three groups applied medication on the site of pain in their legs three times a day for three days and recorded the severity of pain four hours after morning and afternoon applications . Mean pain severity during three days of intervention was considered as the severity of pain after intervention. Data were collected using a demographic and disease questionnaire and numeric rating scale for Pain, we investigated the effectiveness of these two drugs on pain patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101430296N1
Registration date: 2016-10-30, 1395/08/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Sekine Keshavarzian Kelishadi
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3748 2010
Email address
s.keshavarzian@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vince Chancellor for Research, Isfahan University Of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-05-19, 1395/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of topical application of rosemary and menthol on musculoskeletal pain in hemodialysis patients
Public title
the effect of topical application of rosemary and menthol on musculoskeletal pain in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Thay have constant and active file in hemodialysis ward, Age between18-65 years, There was no known history of muscle diseases, Were fully alert, During the study werenot transplant candidates, Not addiction, There was no injury to the skin Such as skin rashes or ulcers at the site of drug, Not having legs vascular access, Haveing the ability to communicate verbally, They passed at least 3 months of starting dialysis, Hemodialysis three times a week, Were literate And reported pain severity was at least four in the lower extremities. Exclusion criteria: the patients who do not like to continue to participate in the study, Hospitalization during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commmittee of Isfahan University Of Medical Sciences
Street address
Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Postal code
8147673461
Approval date
2016-02-09, 1394/11/20
Ethics committee reference number
IR.mui.rec.394968

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
N19
ICD-10 code description
Unspecified kidney failure

2

Description of health condition studied
HEMODIALYSIS PATIENT
ICD-10 code
N17
ICD-10 code description
Acute renal failure

Primary outcomes

1

Description
pain severity
Timepoint
Before intervention and 4 hours after taking the medication in the morning and afternoon during the study
Method of measurement
numeric rating scale for Pain

Secondary outcomes

empty

Intervention groups

1

Description
During the three day study, subjects in the intervention group with Menthol, Menthol Drops 5% used 10 drops topically three times a day at the site of the pain
Category
Treatment - Drugs

2

Description
During the three day study, subjects in the intervention group with rosemary used rosemary spray (containing 1 and 8 Cineole, kanazol) 2 puffs topically three times a day at the site of the pain
Category
Treatment - Drugs

3

Description
During the three day study, subjects in the placebo treatment group used Vaseline 1 Ablykatvr topically three times a day at the site of the pain
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
khorshid Hospital
Full name of responsible person
sekine keshavarziankelishadi
Street address
ostandari avenue, Isfahan, Iran
City
Isfahan

2

Recruitment center
Name of recruitment center
Emam Khomeini falavarjan Hospital
Full name of responsible person
sekine keshavarzian kelishadi
Street address
Basig Boulevard ,falavarjan ,isfahan
City
Isfahan

3

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
sekine keshavarzian kelishadi
Street address
Ebne sina avenue, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vince Chancellor for Research, Isfahan University Of Medical Sciences
Full name of responsible person
Dr Mahdi Nematbakhsh phD in physiology
Street address
Hezar jrib Avenue, Isfahan University Of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vince Chancellor for Research, Isfahan University Of Medical Sciences
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
Isfahan University Of Medical Science, Faculty Of Nursing and Midwifery
Full name of responsible person
Nahid Shahgholian
Position
Msc of nursing,Department of special care, Member of nursing and midwifery care research center,
Other areas of specialty/work
Street address
Faculty Of Nursing and Midwifery, Isfahan University Of Medical Sciences,Hezar jerib
City
Isfahan
Postal code
Phone
+98 31 3792 7539
Fax
Email
Shahgholian @nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty Of Nursing and Midwifery, Isfahan University Of Medical Sciences
Full name of responsible person
sekine keshavarzian kelishadi
Position
Bachelor of nursing(Msc student of nursing)
Other areas of specialty/work
Street address
Faculty Of Nursing and Midwifery, Isfahan University Of Medical science, Hezar jrib avenue,
City
Isfahan
Postal code
Phone
+98 31 3748 2010
Fax
Email
s.keshavarzian@nm.mui.ac.ir;sekinekeshavarzian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty Of Nursing and Midwifery, Isfahan University Of Medical Sciences
Full name of responsible person
sekine keshavarzian kelishadi
Position
Bachelor of nursing(Msc student of nursing)
Other areas of specialty/work
Street address
Faculty Of Nursing and Midwifery, Isfahan University Of Medical science, Hezar jrib avenue,
City
Isfahan
Postal code
Phone
+98 31 3748 2010
Fax
Email
s.keshavarzian@nm.mui.ac.ir;sekinekeshavarzian@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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