1. Home
  2. Approved trials
  3. » فارسی

Compare Zayla-Cream and ice compress on the level of stress, pain and cardiovascular response from due to needles insertion into arteriovenous fistula in hemodialysis.

Protocol summary

Summary
The aim of this study is to compare Zayla-Cream and ice compress on the level of stress, pain and cardiovascular response from due to needles insertion into arteriovenous fistula in hemodialysis patients. Design: randomized, placebo-controlled, single-center, phase II clinical trial. How to do: The study population included patients undergoing hemodialysis via arteriovenous fistula in Imam Hossein hospital, Shahroud. By using simple random sampling 50 hemodialysis patients allocate in three groups (Zayla cream, ice pack and placebo). The main inclusion criteria: patients age 18 year or older; be conscious; at least three months past their fistula embedded; the absence of skin damage in the desired position and lack of skin allergy to local anesthetics. The main exclusion criteria: use of analgesics in the past 24 hours; the patient's unwillingness to continue the study and the patient died. Interventions: At first step the intensity of stress, pain and cardiovascular changes induced by vein puncture will be measured after using the ice pack (placebo) on the site of injection. One week later (wash out), patients put under the intervention with Zayla cream, so that cream with an area of 5 cm² will be applied 10 minutes before inserting the needle on the fistula, after one week (wash out) they will received ice packs 10 minutes before the fistula needle placed in the area. The intensity of stress before injection and the intensity pain after injection will be evaluated and recorded by visual stress analogue scale and visual pain analogue Scale, respectively. Vital signs before and after the injection will be measured. Each intervention will be done at two intermittent Hemodialysis sessions. The main outcome variable: pain, stress, systolic blood pressure, diastolic blood pressure and pulse.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050427744N1
Registration date: 2016-06-11, 1395/03/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-11, 1395/03/22
Registrant information
Name
Ziba Ghoreishi
Name of organization / entity
Shahroud university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
ghoreyshi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare Zayla-Cream and ice compress on the level of stress, pain and cardiovascular response from due to needles insertion into arteriovenous fistula in hemodialysis.
Public title
Compare Zayla-Cream and ice compress on the level of stress, pain and cardiovascular response from due to needles insertion into arteriovenous fistula in hemodialysis.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age over 18 years; being vigilant to time, place and persons at the time collecting the information; Hemodialysis patients who have at least two session of dialysis at week; patients who have at least three months past of their fistula embedding; absence of damaged skin in the desired positions; no known allergy to local anesthetics; without alcohol and drugs consumption; the minimum level of literacy; no history of mental illness with doctor approval. Exclusion criteria: Analgesic use in the past 24 hours; the patient's unwillingness to continue the study; the patient died.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Central building of Shahroud university of medical sciences ,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
IR.shmu.rec.1395.19

Health conditions studied

1

Description of health condition studied
Arteriovenous fistula puncture-related complication in hemodialysis patients
ICD-10 code
T82.4
ICD-10 code description
Mechanical complication of vascular dialysis catheter

Primary outcomes

1

Description
Stress
Timepoint
After every intervention and before the fistula needle
Method of measurement
Stress visual analogue scale

2

Description
Pain
Timepoint
After every intervention and mmediately after the fistula needle
Method of measurement
Visual analoug scale

3

Description
Blood pressure
Timepoint
After every intervention and before and after the fistula needle
Method of measurement
Stigno monometer

4

Description
Pulse
Timepoint
After every intervention before and after the fistula
Method of measurement
Analog clock with seconds

Secondary outcomes

empty

Intervention groups

1

Description
Interventions 1: At first, the patients complete a demographic questionnaire, based on it, the qualified patients will be enrolled in the study. At First week, the intensity of stress before injection and the intensity of pain after injection with putting of placebo will be evaluated and recorded by visual stress analogue scale and visual pain analogue Scale, respectively. Also heart and cardiovascular changes in arterial venous fistula will be measured before and after injection.
Category
Placebo

2

Description
Interventions 2: After one week, the intervention with Zaylapy cream will be done in which, in all patients, 10 minutes before inserting the needle in fistula, cream with the area of 5 cm2 will be applied to the area. Do not put a cover over the area, then the cream will be cleared and skin will be disinfected for Vncopanccher. Then, the intensity of stress before injection and the intensity of pain after injection with putting of placebo will be evaluated and recorded by visual stress analogue scale and visual pain analogue Scale, respectively. This intervention will be done at two intermittent Hemodialysis sessions.
Category
Treatment - Drugs

3

Description
Interventions 3: In this group, 10 minutes before inserting the needle in fistula, ice will be placed around the fistula. Then the skin will be dried and disinfected and needle inserted in fistula. The intensity of stress and vital signs before injection and the intensity of pain and vital signs after injection will be evaluated and recorded.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahroud Imam Hussein Hospital
Full name of responsible person
Ziba Ghoreishi
Street address
Shahroud, Imam Hosein Hospital
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud university of medical sciences ,Hafte Tir Square, Shahroud .
City
Shahroud
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; Shahroud 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
Shahroud university of medical sciences
Full name of responsible person
Ziba Ghoreishi
Position
Graduate student of Critical Care Nurses
Other areas of specialty/work
Street address
Shahroud university of Medical Sciences and Health Services, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 3811
Fax
Email
ghoreyshi@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Hossin Ebrahimi
Position
Faculty member
Other areas of specialty/work
Street address
Central building ofShahroud University of Medical Sciences,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 3811
Fax
Email
h_ebrahimi43@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Ziba Ghoreishi
Position
Graduate students Intensive Care Nursing
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 3811
Fax
+98 23 3239 5054
Email
ghoreysh@shmu.ac.ir; ziba.ghorishi@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
Loading...