Objective; this study is performed to assess the effect of inhalation aromatherapy with Lavender essence on the pain caused by arteriovenous fistula puncture in hemodialysis patients. Design; this study is a controlled randomized clinical trial. Setting and conduct; Nineteen eligible patients will be randomly placed in experimental and control groups. Demographic and clinical characteristics of the patients will be recorded with questionnaire. Patient including major criteria; 3 times a week dialysis; being over 18; alertness and ability to communicate and having a good sense of smell.
Patient eligibility major criteria; candidate for a transplant; pregnancy; record of allergies; chronic respiratory diseases; using analgesic in 3 hours and drug addiction. Intervention; ninety two hemodialysis patients with AVF will be randomly divided into two groups. In the first time, the fistula needle pain will be measured with Visual Analogue Scale (VAS) in two groups. The experimental group will be inhaled with 10% lavender essence for five minutes in three consecutive dialysis sessions but the control group will be inhaled the placebo. Patients ' pain will be measured after three interventions in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307047494N6
Registration date:2013-07-21, 1392/04/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-21, 1392/04/30
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences.
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Lavender essence on pain from the fistula needle in patients undergoing hemodialysis
Public title
The effect of aromatherapy with Lavender essence on pain from the fistula needle in patients undergoing hemodialysis
Purpose
Health service research
Inclusion/Exclusion criteria
Patient including major criteria; 3 times a week dialysis; being over 18; alertness and ability to communicate and having a good sense of smell.
Patient eligibility major criteria; candidate for a transplant; pregnancy; record of allergies; chronic respiratory diseases; using analgesic in 3 hours and drug addiction
Age
From 18 years old to 130 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Science
Street address
Moalem Street, Moalem Square, Sari .
City
Sari
Postal code
4816715793
Approval date
2013-05-29, 1392/03/08
Ethics committee reference number
334 - 91
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
The pain from the fistula needle
Timepoint
Before intervention and after 3 interventions
Method of measurement
Visual Pain Scale
Secondary outcomes
1
Description
Allergic to Lavender
Timepoint
To 6 days after the first intervention.
Method of measurement
Side effects of the drug and the patient's questions
Intervention groups
1
Description
On the first day of the study (before the intervention), the pain from the fistula needle will be measured and recorded.
Experimental group: experimental group will be exposed to the inhalation of lavender essence produced by Barij certified pharmaceutical company with quality standards of ISO 9001 and ISO / IEC 17025 at a concentration of 10% for 3 consecutive times (once for each hemodialysis). Lavender essence is produced from fresh flowering parts of the plant which contains Linalool, Linalool acetate, Caffeic acid and Tannins. Since pure lavender essence is highly concentrated and its use irritates the patients, the essence is diluted with sweet almond oil with one in- ten proportion and 10% compound is produced. A total of 3 interventions during three sessions of dialysis will be performed. Thus, a cotton ball soaked with 3 drops of lavender essence with concentration of 10% will be put at a distance of 10 cm and the patient will be asked to breathe slowly for 5 minutes . Fistula is then punctured. Needles used are the same for all patients taken from Soha Company with the number of BNO: P 948115 A MFG. In each intervention, the VAS pain scale is measured after aromatherapy.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group will be treated by the above method under aromatherapy with placebo. The placebo is produced by Barij Essence Company and include a base combination of an aromatherapy without lavender. For the preparation of the compound, one drop of the lavender essence is poured into the base solution which is sweet almond oil to make it dilute and cause it to have the same smell without having its properties.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Emam Khomeini hospital
Full name of responsible person
Dr Masoumeh Bagheri- Nesami
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences Sari, Iran.
City
Sari
2
Recruitment center
Name of recruitment center
Sari Fatima Zahra hospital
Full name of responsible person
Dr Masoumeh Bagheri- Nesami
Street address
Mazandaran University of Medical Sciences, Juibar, Sari.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran..
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Science
Full name of responsible person
Dr Mohamad Ali Heydari Gorji
Position
Phd- faculty
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Sari, Iran.
City
Sari
Postal code
4816715793
Phone
+98 15 1326 1245
Fax
Email
heydarigorji@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
Phd- Faculty
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical, Sciences, Sari, Iran.
City
Sari
Postal code
4816715793
Phone
+98 15 1326 1245
Fax
Email
anna3043@gmail.com
Web page address
www..mazums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)