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Comparative study of the Effects of Emla Cream and Diclofenac Gel on Chemo Port Pain in patients Referring to Oncology wards in Zahedan University of Medical Sciences Affiliated Hospitals

Protocol summary

Summary
The aim of this study was to compare the effects of diclofenac spell and denture on pain caused by port insertion in patients undergoing chemotherapy in the Oncology Department of Zahedan University of Medical Sciences, Randomized, Double-blind, Controlled Patients. Entry criteria: willingness to participate in research; having verbal, subjective, vision; presently not having acute psychiatric disorders; history of fauxism; congenital idiopathic hemoglobinemia; liver disease; skin allergy; skin dermatitis; lack of treatment with sulfonamide , Nitrates and phenobarbital, non-diabetes, non-addiction, non-use of housing within the last 24 hours. Exit criteria: The wound of the port's location during the intervention; Infection and secretion at the port site during the intervention; Failure to reach the first action. Interventions: Diclofenac gel for 1 hour, one gram for one hour, one gram for 1 hour cream for 1 hour, vitamin A + D cream for one hour. Main outcome variable: diclofenac gel, spellet cream, vitamin A + D cream.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080635520N1
Registration date: 2017-08-30, 1396/06/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-30, 1396/06/08
Registrant information
Name
Alireza Salar
Name of organization / entity
Faculty of nursing and midwifery Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
salar@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research zahedan University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the Effects of Emla Cream and Diclofenac Gel on Chemo Port Pain in patients Referring to Oncology wards in Zahedan University of Medical Sciences Affiliated Hospitals
Public title
Comparative study of the Effects of Emla Cream and Diclofenac Gel on Chemo Port Pain in patients Referring to Oncology wards in Zahedan University of Medical Sciences Affiliated Hospitals
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Inclination to participate in research; Having verbal, subjective, vision ability; At present there is no acute psychiatric disorder; There is no history of favism, congenital idiopathic hemoglobin, liver disease, skin allergy, skin dermatitis; no treatment with sulfonamides, nitrates Phenobarbital, non-diabetes, non-addiction, non-use of housing in the last 24 hours. Exit criteria: The wound of the port's location during the intervention; Infection and secretion at the port site during the intervention; Failure to follow the first action.
Age
From 12 years old to 99 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Zahedan university of medical sciences
Street address
Administrative Complex of Khalij Fars Blvd. University of Medical Sciences, Dr Hasabi Square, Zahedan
City
Zahedan
Postal code
98167-43463
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
ir.zaums.rec.1396.103

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
E2
ICD-10 code description
Neoplasms

Primary outcomes

1

Description
Emlacream
Timepoint
During the intervention
Method of measurement
Geram

2

Description
Diclofenac gel
Timepoint
During the intervention
Method of measurement
Geram

3

Description
Vitamin(A+D)
Timepoint
During the intervention
Method of measurement
Geram

Secondary outcomes

1

Description
Sex
Timepoint
During the intervention
Method of measurement
Patient case

2

Description
Duration under chemotherapy
Timepoint
During the intervention
Method of measurement
Day

3

Description
Age
Timepoint
During the intervention
Method of measurement
Years

4

Description
Severity of pain
Timepoint
During the intervention
Method of measurement
Vas

5

Description
Duration of port usage
Timepoint
During the intervention
Method of measurement
Day

Intervention groups

1

Description
diclofenac jel .1 geram.1 our once
Category
Treatment - Drugs

2

Description
emla cream .topical 1 geram.1ouronce
Category
Treatment - Drugs

3

Description
vitamin(A+D).1 geram.1 our once
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Oncology Department of Khatam-ol-Anbia Hospital in Zahedan
Full name of responsible person
Shima Mohamadi Nejad
Street address
Khatam-al-Anbia Hospital, Khatam al-Anbia Square
City
Zahedan

2

Recruitment center
Name of recruitment center
Department of Oncology, Ali Ibn Abi Talib Hospital
Full name of responsible person
Shima Mohamadi Nejad
Street address
Dr. Ali Saba Hospital, Ali ibn Abi Talib
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Zahedan University of Medical Sciences
Full name of responsible person
Dr Nourmohammad Bakhshani
Street address
Administrative Complex of Khalij Fars Blvd. University of Medical Sciences, Dr Hasabi Square, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Zahedan 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
Zahedan Nursing Midwifery Faculty
Full name of responsible person
Shima Mohammadinejad
Position
Master of Internal and Surgical
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Fellowship Square
City
Zahedan
Postal code
Phone
Fax
Email
Sh.mohamadi90@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan Nursing Midwifery Faculty
Full name of responsible person
Alireza Salar
Position
Ph.D. Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Fellowship Square
City
Zahedan
Postal code
9816743463
Phone
Fax
Email
salar293@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan Nursing Midwifery Faculty
Full name of responsible person
Shima Mohamadi Nejad
Position
Master of Internal and Surgical
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Fellowship Square
City
Zahedan
Postal code
9816743463
Phone
Fax
Email
Sh.mohamadi90@yahoo.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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