Protocol summary

Study aim
Comparison the effectiveness of vapocoolant versus lidocaine spray on pain intensity due to insertion of vascular needles in hemodialysis patients
Design
The study is a three period cross over double blind randomized Clinical Trial which carry on 4 patients. Randomization is done via blocking and random numbers table.
Settings and conduct
The first needling is performed without any intervention, the pain score is determined one minute after needling.Each of the samples in the next dialysis randomly receives one of the following interventions: vapocoolant ,10% lidocaine spray and placebo(water) in 2 weeks intervals.Vapocoolant sprayed on the skin at a distance of 20 cm for 3 or 4 seconds, allowing the skin to dry for 10 seconds, then disinfect the skin (uniformly temperature-sensitive and uniform for all patients) and 20 seconds after, vascular access is done.Two puff lidocaine sprays are sprayed at approximately 5 cm, 5 minutes after spraying and after disinfection,vascular access is done by the nurse. Inusing the placebo spray, two puff are sprayed at a distance of 5 cm, 5 minutes after spraying and disinfection, vascular access is done.The outer part sprays is covered with paper.The coworker applied the spray to the skin and one minute after needling, the patient's pain score is determined by the presenter without the knowledge of the type of spray. In all patients, the size of needle is 16. In the total stages in each patient, one nurse will work. Nurse and patient will not be aware of the spray type.
Participants/Inclusion and exclusion criteria
All hemodialysis patients. Entering criteria: arteriovenous fistula.Not entering:cardiac disease,lidocain reaction
Intervention groups
The samples in the next dialysis session randomly receives one of the following interventions:vapocoolant spray, 10% lidocaine spray and placebo spray.
Main outcome variables
Reducing the venous access pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180826040868N1
Registration date: 2018-09-15, 1397/06/24
Registration timing: prospective

Last update: 2018-09-15, 1397/06/24
Update count: 0
Registration date
2018-09-15, 1397/06/24
Registrant information
Name
Sima Sadat Hejazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7157
Email address
s.hejazi@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of vapocoolant spray versus lidocaine spray on pain intensity due to insertion of vascular needles in hemodialysis patients
Public title
Effectiveness of vapocoolant spray versus lidocaine spray on vascular needle pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
GCS 15 Ability to speak and understand Farsi or having Persian language translator Not have pacemaker Not have Known cardiac disease Start hemodialysis at least 3 months ago Not have Known reaction to lidocaine Products Not have damaged skin Not analgesic use in the last 24 hours Not use of the cream or products lidocaine in the past Hemodialysis via arteriovenous fistula Not anti arrhythmic medications use (especially Class 3 for example Amiodarone) Perform dialysis three times a week age more than 18 age less than 80
Exclusion criteria:
Skin reaction or abnormal response in arteriovenous fistula site Absence to perform hemodialysis Failure in vascular access by first try at any of the stages
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
All patients undergoing hemodialysis with inclusion criteria are randomly assigned to three intervention groups. First, ABCs, BACs, ACBs, BCAs, CABs, CBAs, and CABs are considered and from zero to five number are allocated to each block, respectively (A vapocoolant spray group, B lidocaine sprays group, C placebo spray group). Then, from the random number table, the number of random samples according to sample size in each group is selected, after deleting the numbers from 6 to 9, is assigned to each corresponding block number. Then numbered and according to the list, patients are assigned to one of three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants blinding (patients) and clinical caregiver: To prepare placebo sprays, we will empty the lid of lidocaine spray dish and spill it into it. The outer part of each of the three sprays is covered with paper to have an almost identical appearance. Outcome evaluator blinding: In all cases, the coolaborator applies the spray to the skin of the patients and the question of pain score is performed by the executor without notice of the type of spray used. When applying sprays, the executor is not present at the patient's bedside.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.NKUMS.REC.1397.035

Health conditions studied

1

Description of health condition studied
Venous access pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified

Primary outcomes

1

Description
Pain score
Timepoint
At the beginning of study, two days after, two weeks after the first intervention, four weeks after the first intervention and six weeks after the first intervention
Method of measurement
Numerical Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Each of the samples in the next dialysis session (two days later) randomly receives one of the following interventions: a vapocoolant spray, 10% lidocaine spray and a placebo spray. Samples who first received a vapocoolant spray (two days later From the initial needle that was without any intervention), two weeks later, lidocaine sprays and four weeks later receive placebo spray. Patients who first receive lidocaine spray receive a vapocoolant spray two weeks after the lidocaine spray, placebo spray, and four weeks after the lidocaine spray, and patients who received the first placebo, two weeks later, a vapocoolant spray and four weeks Lidocaine spray is then applied to the skin.
Category
Prevention

2

Description
Control group: Since the study design is cross-over, each patient is considered to be a control group and receives a placebo spray.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali Hospital of Bojnurd
Full name of responsible person
Sima Sadat Hejazi
Street address
Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7010
Email
s.hejazi@nkums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Seyed Kave Hojjat
Street address
Dolat Blvd
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3222 1910
Email
S.Kavehhojjat1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd University of Medical Sciences
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
Bojnourd University of Medical Sciences
Full name of responsible person
Sima Sadat Hejazi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7096
Email
s.hejazi@nkums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Sima Sadat Hejazi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7096
Email
s.hejazi@nkums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Sima Sadat Hejazi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7096
Email
s.hejazi@nkums.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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