Protocol summary

Study aim
Comparison of the effect of Epsom salt spray and wet hot compress on the rate of infiltration, phlebitis and peripheral venous pain in children
Design
This study is a clinical trial with a control group, with parallel, double-blind, randomized phase 3 groups that will be performed on 114 children with phlebitis, infiltration and pain caused by peripheral venous catheter. Participants will be assigned in three groups (two internal groups and one control group) randomly with triple blocks.
Settings and conduct
This study will be performed on children admitted to the pediatric, surgical and emergency department of Allameh Bohlool Gonabadi Hospital. The children with venous complication, after obtaining the consent to participate in the study, are randomly divided into three groups: Epsom Salt spray, hot compress and control. The intervention will be performed as mentioned and then the data will be compared in three groups.The present study is a two-way blind study and the data collector, analyst and individuals under study will not be aware of the allocation of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children older than 6 months. Having peripheral venous complications based on relevant scales. Consent of one of the parents to participate in the project. Exclusion criteria: Having a history of skin allergies. Having open wounds in the study area. Having kidney failure.
Intervention groups
In intervention groups, wet hot compress or Epsom salt solution is placed in the involved position for 20 minutes. This intervention will be performed every 6 hours, and each time after the intervention at the end of 24 hours after the complication the pain, infiltration and phlebitis of the child will be measured.
Main outcome variables
Reduction of phlebitis, infiltration and pain caused by peripheral venous catheter

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201107049290N1
Registration date: 2021-01-16, 1399/10/27
Registration timing: registered_while_recruiting

Last update: 2021-01-16, 1399/10/27
Update count: 0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Fatemeh HosseiniMoghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
hosseini.f@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of warm wet compresses and Epsom salt spray on reducing infiltration, phlebitis and peripheral venous pain in children
Public title
The effect of Epsom spray on infiltration, phlebitis and peripheral venous pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children older than 6 months, Having peripheral venous complications based on relevant scales. Consent of one of the parents to participate in the project,
Exclusion criteria:
Having a history of skin allergies Having open wounds in the study area Having kidney failure
Age
From 6 months old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Children with peripheral venous complication will be selected based on inclusion criteria. Participants will be assigned to three groups using the permutation block method. In this study, the letter A is considered as intervention group 1 (Epsom salt spray), the letter B as intervention group 2 (hot compress) and the letter C as the control group. The size of each block is 3 people, the total number of blocks is 30 and the possible permutations are 6 modes. A code will be assigned to each of the triple blocks; Thus ABC is given code 1, ACB code 2, BAC code 3, BCA code 4, CAB code 5 and CBA code 6. Then, using "random number table" the order of assigning people in groups ,by selecting a random number and then scrolling down, will be obtained. If the number was between 1 and 6, the state related to that code is recorded, and if it was from zero and 7 to 9, the next number is selected. This will continue until the required sample size is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
For data blinding, the data collector, the analyst, and the subjects will not be aware of the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Saadi Town, 14 Golhaei St., No. 14
City
Gonabad
Province
Razavi Khorasan
Postal code
9691938775
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
IR.GMU.REC.1399.080

Health conditions studied

1

Description of health condition studied
Infiltration and phlebitis caused by peripheral venous catheter
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Degree of infiltration
Timepoint
Determination of infiltration degree before intervention, 6, 12 and 24 hours after intervention
Method of measurement
Pediatric peripheral intravenous infiltration assessment tool

2

Description
Phlebit degree
Timepoint
Determination of Phlebit degree before intervention, 6, 12 and 24 hours after intervention
Method of measurement
Phlebit Visual Scale

3

Description
Pain score
Timepoint
Determination of Pain score before intervention, 6, 12 and 24 hours after intervention
Method of measurement
Face, Legs, Activity, Cry, Consolability scale (FLACC scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In this group, gas impregnated with Epsom salt solution is placed in the involved position for 20 minutes. Epsom salt solution will be prepared by the researcher by combining 20 grams of magnesium sulfate salt with 100 cc of distilled water and stored at room temperature.This intervention will be performed for the child two more times, every 6 hours, and each time after the intervention, the pain, infiltration and phlebitis of the child will be measured.
Category
Treatment - Other

2

Description
Intervention group2: In this group, hot compresses are placed in the involved position for 20 minutes. This intervention will be performed for the child two more times, every 6 hours, and each time after the intervention, the pain, infiltration and phlebitis of the child will be measured.
Category
Treatment - Other

3

Description
Control group: No special intervention has been performed for this group and they will be examined only for pain, infiltration and phlebitis.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Bohlool Gonabadi Hospital
Full name of responsible person
Fatemeh HosseiniMoghddam
Street address
Parstar Blvd. Allameh Bohlool Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691938775
Phone
+98 51 5723 6833
Email
Hosseini.M@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Asian roadside. Gonabad University of Medical Sciences. Deputy of research and technology
City
Gonabad
Province
Razavi Khorasan
Postal code
9691938775
Phone
+98 51 5722 3028
Email
hosseini-m@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Allameh Bohlool Gonabadi Hospital
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
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh HosseiniMoghaddam
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Asian Roadside, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691938775
Phone
+98 51 5722 3028
Fax
Email
Hosseini.f@gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh HosseiniMoghaddam
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Asian Roadside, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691938775
Phone
+98 51 5722 3028
Fax
Email
Hosseini.f@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh HosseiniMoghaddam
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Asian Roadside, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691938775
Phone
+98 51 5722 3028
Fax
Email
Hosseini.f@gmu.ac.ir

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
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