1. Home
  2. Approved trials
  3. » فارسی

The effect of inhalation of aromatherapy (Lavender Essential Oil) on post operative discectomy pain

Protocol summary

Summary
This study is a clinical trial of an quasi experimental study. After getting permission from the authorities and informed consent of the participants in the study, patients undergoing discectomy through a available sampling of the number (60) were selected and random allocation block in the two groups will. Inclusion criteria were: age over 18 years, having the ability to understand language of Persian or Turkish, Lacking a history of allergy to plants, lack of pregnancy, lack of hypertension, The lack of clotting disorders and Having sense of smell and vision healthy. Since the use drug is in the form of inhaler and the pain of intensity will be evaluated using the VAS tool, sense of smell and vision before entering the people in the study by using test sense of smell, and visual acuity will be examined. In this study, the experimental group, the essential oil of lavender will be prepared of the company of Kashan Barych Esance, with the right concentration (recommended texts) through inhalation of used and then, at a certain level of pain intensity will be measured by using the VAS. Similarly placebo in the control group by the same method by the experimental group used and then pain intensity will be evaluated by means of tool VAS. In addition, in order to assess the impact of lavender essential oil compared with placebo, pain intensity in both groups before and after the intervention will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070421403N1
Registration date: 2015-07-04, 1394/04/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-04, 1394/04/13
Registrant information
Name
Gholamreza Arjmand
Name of organization / entity
Zanjan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 5980
Email address
gholamrezaarjmand1981@yahoo.com
Recruitment status
Recruitment complete
Funding source
Financial resources of the project will be provided by Zanjan University of Medical Sciences
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation of aromatherapy (Lavender Essential Oil) on post operative discectomy pain
Public title
The effect of inhalation of aromatherapy (Lavender Essential Oil) on post operative discectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having a willingness to participate in the study; Having a discectomy surgery of lumbar disc; with full awareness and cooperation; Having a good sense of smell; Having a healthy state of mind and vision to see and understand the tool VAS (visual analog scale); age 18 and older; Having the ability to understand language, Persian or Turkish; lacking a history of allergy to plants; The lack of pregnancy, high blood pressure and coagulation Exclusion criteria: Patients with complications such as bleeding;patients undergoing oxygen therapy;The patient's unwillingness to participate in the study after the first intervention because patients may experience unpleasant feeling of these fragrances for various reasons.
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences and Health Services
Street address
Zanjan, Azadi Square, The beginning of the Islamic Republic Boulevard, Central Chiefs Zanjan University of Medical Sciences
City
Zanjan
Postal code
45156-13191
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
ZUMS.REC.1393.233

Health conditions studied

1

Description of health condition studied
Pain after lumbar disc surgery
ICD-10 code
Y45.0
ICD-10 code description
Opioids and related analgesics

2

Description of health condition studied
Pain after lumbar disc surgery
ICD-10 code
M51.2
ICD-10 code description
Other specified intervertebral disc displacement

Primary outcomes

1

Description
Pain severity After Surgery
Timepoint
4, 8 , 12 hours after the onset of pain after surgery
Method of measurement
Visual Analog Scale and record the questionnaire

Secondary outcomes

1

Description
The postoperative opioid consumption
Timepoint
During the intervention
Method of measurement
Through patient records

Intervention groups

1

Description
Intervention in interventional groups: a total of 3 times intervention in the first day after surgery (4, 8 and 12 hours after the onset of pain after surgery) done for patients. Description work In this way three drops of aromatherapy blend containing Lavender essence 10% (provided by The Barij Essence Pharmaceutical Compnay) were poured on cotton pellet, and the patient was asked to inhale it for 5 minutes from a distance of 10 cm; and pain score was measured using the VAS again, (Intervention with drug use)
Category
Treatment - Drugs

2

Description
Intervention in the control group: a total of 3 times intervention in the first day after surgery (4, 8 and 12 hours after the onset of pain after surgery) done for patients. Description work In this way three drops three drops of sweet almond oil (placebo) (provided by The Barij Essence Pharmaceutical Compnay) were poured on cotton pellet, and the patient was asked to inhale it for 5 minutes from a distance of 10 cm; and pain score was measured using the VAS again ( with placebo use).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Hospital Tabriz
Full name of responsible person
DR.Iraj Lutfinia (specialist neurosurgery, Professor) - DR. Mohammad shimia (specialist neurosurger,
Street address
Tabriz - Golshahr - Shohada Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Soghrat Faghihzadeh
Street address
Zanjan, Azadi Square, The beginning of the Islamic Republic Boulevard, Central Chiefs Zanjan University of Medical Sciences
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Gholamreza Arjmand
Position
McS in Critical Care Nursing
Other areas of specialty/work
Street address
Tabriz - Golshahr - Shohada Hospital
City
Tabriz
Postal code
5167846171
Phone
+98 41 3389 3221
Fax
+98 41 3389 3337
Email
gholamrezaarjmand1981@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Nasrin Bahram nezhad
Position
PhD in community health
Other areas of specialty/work
Street address
Zanjan, Azadi Square , The beginning of the Islamic Republic Boulevard, Zanjan University of Medical Sciences
City
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Fax
+98 24 3342 4774
Email
Nasrin4807@yahoo.com
Web page address
http://www.zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Gholamreza Arjmand
Position
McS in Critical Care Nursing
Other areas of specialty/work
Street address
Tabriz - Golshahr - Shohada Hospital
City
Tabriz
Postal code
5167846171
Phone
+98 41 3389 3221
Fax
+98 41 3389 3337
Email
gholamrezaarjmand1981@yahoo.com
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
Loading...