Protocol summary

Summary
This study aimed to investigate the effect of aromatherapy on patients’ pain in orthopedic surgery. The participants in this study were 80 patients both male and female who had gone to the orthopedic ward of Akhtar, Ayatollah Taleqani, and Emam Hossein hospitals in Tehran. Their age range was between 15 to 55. The participants were divided into two groups of experimental and control. Random number table (0-4) and Random block recipients (5-9) were used for the control and experimental groups respectively. No intervention was applied for the control group. Each t patient’s pain was measured before the intervention and the night before surgery at 9 PM. Then 8 and 16 hours after surgery while three hours had passed since the last time patients had received parental analgesics, patients’ pain was measured through the use of VAS scale half an hour after the intervention. In the aromatherapy intervention group, three drops of citrus lemon using a dropper was dropped on an impenetrable handkerchief and attached to the patient’s collar. In addition, the patient was asked to breathe it for about 20 to 30 minutes and then the two groups were compared.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015081723655N1
Registration date: 2015-09-08, 1394/06/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
Mahboubeh Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
mahnazari2010@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Eeffect of Aromatherapy on pain in patients undergoing ortopedic surgery
Public title
Investigating The Effect of
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Male and female patients 15 to 55 years, patients undergoing orthopedic surgery (distal radius fracture), the same procedure Exclusion criteria: use of anti-anxiety drugs and herbal medicines, drug addiction (according to patient), and health employment and No history of vision and hearing and smell problems, having respiratory problems and allergic to liver problems and kidney surgery complicate the withdrawal from the study at any stage of the intervention (Aromatherapy)
Age
From 15 years old to 55 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
Not used
Assignment
Parallel
Other design features
Sampling is random block recipients into two groups

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad university tehran medical branch
Street address
Shahid Khaghani st (Zargande st) tehran
City
tehran
Postal code
1916893813
Approval date
2015-03-10, 1393/12/19
Ethics committee reference number
1045

Health conditions studied

1

Description of health condition studied
Fracture of lower end of radius
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius

Primary outcomes

1

Description
variable Pain
Timepoint
basic pain , 8 and 16 hour after the surjery
Method of measurement
by using VAS scale

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group :No intervention was applied for the control group
Category
Prevention

2

Description
In the aromatherapy intervention group 1: three drops of citrus lemon using a dropper was dropped on an impenetrable handkerchief and attached to the patient’s collar. In addition, the patient was asked to breathe it for about 20 to 30 minutes and then the two groups were compared.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical Center Hospital Akhtar
Full name of responsible person
Mahboubeh Nazari
Street address
Sharifi Manesh St, Poule Roomi Ave, Shariati St, Teharn, Iran.
City
Tehran

2

Recruitment center
Name of recruitment center
Medical Center Hospital Imam Hussein (AS)
Full name of responsible person
Mahboubeh Nazari
Street address
Medical Center Hospital Imam Hussein (AS), Madani Street, Tehran, Iran
City
Tehran

3

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital Medical Center
Full name of responsible person
Mahboubeh Nazari
Street address
Taleghani Educational Hospital,Tabnak St, Velenjak Region, Chamran High Way,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
-
Full name of responsible person
Investigator
Street address
khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
-
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
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Mahboubeh Nazari
Position
Student of Master Degree in Medical Surgical Nursing
Other areas of specialty/work
Street address
khaghani st, shariati Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2200 6661
Fax
Email
mahnazari2010@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad university tehran medical branch Faculty of Nursing & Midwifery
Full name of responsible person
Mahboubeh nazari
Position
Student of Master Degree in Medical Surgical Nursing
Other areas of specialty/work
Street address
khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 21220066616
Fax
Email
mahnazari2010@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
tehran medical branch (Faculty of Nursing & Midwifery )
Full name of responsible person
Mahboubeh Nazari
Position
Student of Master Degree in Medical Surgical Nursing
Other areas of specialty/work
Street address
khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 21220066616
Fax
Email
mahnzari2010@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
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