The most frequent complaint is pain in the bone marrow biopsy. In many studies, it is considered unacceptable pain for patients. Experienced pain during and after the procedure causes fear and patients unwilling to continue the follow-up biopsy. One of the factors affecting the pain and anxiety before the procedure is a bone marrow examination.
This investigation aimed to determine the clinical trial is done and its purpose of inhalation of lavender on pain and anxiety caused by bone marrow aspiration. The study included 40 subjects in the intervention and control groups is, in both pain and anxiety before the intervention will be investigated and then the control group patients before bone marrow examination 3 drops of distilled water was dropped on a cotton ball placed inside a sealed container from a distance of 7-10 cm will inhale for 10 minutes. In the experimental group, inhaling lavender, 3 drops of lavender on a cotton spinner bullet and placed inside a box and closed one of the volunteers will be asked to open the door cans and at a distance of 10-7 inches from nose to breathe normally befor 10 minutes. The pain and anxiety after the intervention studied. Then will be compare the results from both methods .
General information
Acronym
Bone marrow aspiration
IRCT registration information
IRCT registration number:IRCT2016121431417N1
Registration date:2017-02-13, 1395/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Fariba Tabari
Name of organization / entity
School of Nursing and Midwifery ,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4327
Email address
ftabari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of inhaling lavender on pain and anxiety caused by bone marrow aspiration
Public title
The effects of inhaling lavender on bone marrow aspiration
Purpose
Supportive
Inclusion/Exclusion criteria
• age 18 and older
• being alert to time, place and persons at the time of data collection.
• insensitivity to lavender
• no history for alcohol and drugs consumption
• having the ability to smell
• education at least literate
• no history of mental illness
• lack of moderate and severe pain
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is a clinical trial that aims to determine the effect of inhalation of lavender on pain and anxiety caused by bone marrow aspiration. RAS generated random sequence using the software and immediately after the biopsy pain and anxiety in patients studied. In the test group to inhale the scent of lavender as well as consult with teachers of traditional medicine 15 minutes before a bone marrow examination 3 drops of lavender ten percent on a cotton ball with spinner inside a box closed one set, and the candidate will be asked doors open cans at a distance of 10-7 inches from nose to breathe normally for 15 minutes until pain and anxiety immediately after the biopsy should be considered. The results of the two methods will be compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
1419733171
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
IR.TUMS.FNM.REC.1395.780
Health conditions studied
1
Description of health condition studied
Bone marrow puncture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Immediately after biopsy
Method of measurement
Data collection Visual Analogue Scale
Secondary outcomes
1
Description
Anxiety
Timepoint
Immediately after sampling
Method of measurement
Anxiety Visual Scale
Intervention groups
1
Description
The most frequent complaint is pain in the bone marrow biopsy. In many studies, it is considered unacceptable pain for patients. Experienced pain during and after the procedure causes fear and patients unwilling to continue the follow-up biopsy. One of the factors affecting the pain and anxiety before the procedure is a bone marrow examination.
This investigation aimed to determine the clinical trial is done and its purpose of inhalation of lavender on pain and anxiety caused by bone marrow aspiration. The study included 40 subjects in the intervention and control groups is, in both pain and anxiety before the intervention will be investigated and then the control group patients before bone marrow examination 3 drops of distilled water was dropped on a cotton ball placed inside a sealed container from a distance of 7-10 cm will inhale for 10 minutes. In the experimental group, inhaling lavender, 3 drops of lavender on a cotton spinner bullet and placed inside a box and closed one of the volunteers will be asked to open the door cans and at a distance of 10-7 inches from nose to breathe normally befor 10 minutes. The pain and anxiety after the intervention studied. Then will be compare the results from both methods .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital, Tehran
Full name of responsible person
Fariba Tabari
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Science, Nosrat St. , Tohid Sq., Post Code
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Sixth floor, Tehran University of Medical Sciences, Keshavarz blvd.an
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Fariba Tabari
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tohid Square
City
Tehran
Postal code
Phone
+98 21 6105 4327
Fax
Email
ftabari@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences.
Full name of responsible person
Fariba Tabari
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery,Tohid Square
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
ftabari@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Fariba Tabari
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery,Tohid Square
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
ftabari@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)