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Lavender efficacy on pain of hemodialysis patients, during inserting vascular needles

Protocol summary

Summary
The survey effect of Lavender essence on pain intensity during insertion of vascular needles in hemodialysis patients Design: crossover The main criteria for inclusion: over 18 years old, lack of sensitivity to skin test and fragrances, Ensuring the sense of smell, lack of receiving any tranquilizers, sedatives and analgesics prior to 6 hours The main criteria for exclusion: Pregnant women, history of asthma, bronchitis, chronic respiratory disease, addiction, smoking Samples are 30 who each of them will be tested four times (Routine method, Inhalation of Lavender, Local contact of Lavender, Placebo). Firstly, arterial needle is inserted for hemodialysis under completely routine conditions. For next times and randomly the type of intervention is selected in order to test all samples with four methods. Through inhalation method, patients will breathe 6 drops of Lavender dipped in 4x4 gauze while attached to their collar for 5 minutes. In local contact method, Lavender essence is spilled into a vial and spray 3 puffs on puncture site and remained for 5 minutes. In placebo method, 3 puffs of water would be sprayed on puncture site and remained for 5 minutes .The severity of pain assess after insertion arterial needle, before insertion venous needle by means of numeric scale (NRS).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201303076342N3
Registration date: 2013-04-04, 1392/01/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-04, 1392/01/15
Registrant information
Name
Ali Asghar Ghods
Name of organization / entity
Semnan Universioty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4192
Email address
aaghods@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Semnan University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Lavender efficacy on pain of hemodialysis patients, during inserting vascular needles
Public title
effect of lavender on pain
Purpose
Supportive
Inclusion/Exclusion criteria
The main criteria for inclusion: over 18 years old, Alert patients, Hemodialysis patients who need dialysis at least twice per week, not bearing any Eczema and sensitivity to fragrances, lack of sensitivity to skin tests with Lavender essence, Ensuring their sense of smell with lemon smell test, it is at least 6 weeks after placement of fistula, lack of receiving any tranquilizers, sedatives and analgesics prior to 6 hours and negative neuropathy The main criteria for exclusion:Pregnant women, history of asthma , bronchitis, chronic respiratory disease, addiction, smoking, peripheral vascular disease, Migraine records, chronic headaches, recognized psychological diseases based upon patients’ records, failed first vascular access, Hot water bag has been used one night before and any other reasons for lack of cooperation for research continuation….), Also if the patient have pain or irritation at the site of the fistula in those days do not intervention on patient.
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Headquarters Semnan University of Medical Sciences
City
Semnan
Postal code
Approval date
2013-02-13, 1391/11/25
Ethics committee reference number
91/271869

Health conditions studied

1

Description of health condition studied
hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for dialysis

Primary outcomes

1

Description
pain
Timepoint
Immediately after needle insertion
Method of measurement
Numeric Rating Scale for pain

Secondary outcomes

empty

Intervention groups

1

Description
Through inhalation method, patients will breathe 6 drops of Lavender dipped into a 4x4 gauze while attached to their collar for 5 minutes
Category
Other

2

Description
In local contact method, Lavender essence is spilled into a vial, would be sprayed 3 puffs on puncture site and remained for 5 minutes
Category
Other

3

Description
In placebo method, 3 puffs of water would be sprayed on puncture site and remained for 5 minutes
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Neda Hosseini, MS in critical care nursing
Street address
Fatemieh Hospital, 17 shahrivar Bolvar
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Vice Chancellor for Research, Semnan University of Medical Sciences
City
Semnan
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 of Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
PhD
Other areas of specialty/work
Street address
Nursing Faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1335 4170
Fax
Email
aaghods@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
PhD
Other areas of specialty/work
Street address
Nursing Faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1335 4170
Fax
Email
aaghods@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
PhD
Other areas of specialty/work
Street address
Nursing Faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1335 4170
Fax
Email
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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