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Comparison of aromatherapy with essential oils of orange and red flowers on pain after abdominal surgery

Protocol summary

Summary
The present research is a clinical trial which aims to make a comparison between the effect of aromatherapy with orange essential oil and rose essential oil on the pain intensity after abdominal surgery. After receiving code of ethics from Arak University of Medical Sciences and coordinating with Vali-e-Asr hospital, the sampling from surgery ward of this hospital started. The research sample was selected in terms of the inclusion criteria including: 1- patients should be between 18-40 years old, 2- patients should not suffer from acute and chronic pains, 3- patients should not suffer from vision problems, 4- patients should not suffer from mental problems, 5- patients’ sense of smell should be sound, 6- patients should not suffer from any respiratory problems or allergic rhinitis, and 7- patients should not have any experience of hospitalization or medical measures due to mental problems. Also, the exclusion criteria include 1- patients use the other herbal extracts simultaneously, 2- respiratory problems or allergic rhinitis emerge during intervention, and 3-the occurrence of a crisis or an unexpected event during intervention. The sample volume of this research involved 120 patients who were selected using random sampling method and assigned into three groups: 1- aromatherapy with orange essential oil group (40 patients), 2- aromatherapy with rose essential oil group (40 patients) and 3- control group. After obtaining informed consent from the patients, the personal information questionnaire was completed by the researcher through interview with the patient. In the aromatherapy group, during 12 hours after the surgery (immediately after that the patient regains full consciousness, 4, 8, and 12 hours after operation), 1-2 drops of orange or rose essential oil was poured on a tissue and tied to the patient’s shirt collar with a pin 10 cm away from the patient’s head. The Visual Analog Scale (VAS) was used to assess the patient’s pain intensity half an hour after each intervention. In the control group, patients only received the routine care and then the pain intensity was measured immediately after patient’s gaining full consciousness 4, 8, 12 hours after the operation. Since the aromatherapy is used as a supportive treatment method, so the conventional treatments of surgery ward were used to control the patient’s pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112131002N1
Registration date: 2017-05-03, 1396/02/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-03, 1396/02/13
Registrant information
Name
Yasaman Pourandish
Name of organization / entity
Department of Nursing Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 86 3223 9480
Email address
y.pourandish@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology University of Medical Sciences
Expected recruitment start date
2016-06-07, 1395/03/18
Expected recruitment end date
2017-06-08, 1396/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of aromatherapy with essential oils of orange and red flowers on pain after abdominal surgery
Public title
Comparison of aromatherapy with essential oils of orange and red flowers on pain after abdominal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria including: 1- patients should be between 18-40 years old, 2- patients should not suffer from acute and chronic pains, 3- patients should not suffer from vision problems, 4- patients should not suffer from mental problems, 5- patients’ sense of smell should be sound, 6- patients should not suffer from any respiratory problems or allergic rhinitis, and 7- patients should not have any experience of hospitalization or medical measures due to mental problems. Also, the exclusion criteria include 1- patients use the other herbal extracts simultaneously, 2- respiratory problems or allergic rhinitis emerge during intervention, and 3- the occurrence of a crisis or an unexpected event during intervention.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Payambare Azam Complex, Sardasht
City
Arak
Postal code
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
IR.ARAKMU.REC.1395.66

Health conditions studied

1

Description of health condition studied
pain after surgery
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain

Primary outcomes

1

Description
pain after abdominal surgery
Timepoint
After recovery from anesthesia،4،8 and 12 hours after surgery
Method of measurement
Pain measured by VAS

Secondary outcomes

empty

Intervention groups

1

Description
In the aromatherapy group with orange essential oil , during 12 hours after the surgery (immediately after that the patient regains full consciousness, 4, 8, and 12 hours after operation), 1-2 drops of orange essential oil was poured on a tissue and tied to the patient’s shirt collar with a pin 10 cm away from the patient’s head. The Visual Analog Scale (VAS) was used to assess the patient’s pain intensity half an hour after each intervention. Since the aromatherapy is used as a supportive treatment method, so the conventional treatments of surgery ward were used to control the patient’s pain.
Category
Treatment - Other

2

Description
In the aromatherapy group with rose essential oil , during 12 hours after the surgery (immediately after that the patient regains full consciousness, 4, 8, and 12 hours after operation), 1-2 drops of rose essential oil was poured on a tissue and tied to the patient’s shirt collar with a pin 10 cm away from the patient’s head. The Visual Analog Scale (VAS) was used to assess the patient’s pain intensity half an hour after each intervention. Since the aromatherapy is used as a supportive treatment method, so the conventional treatments of surgery ward were used to control the patient’s pain.
Category
Other

3

Description
In the control group, patients only received the routine care and then the pain intensity was measured immediately after patient’s gaining full consciousness 4, 8, 12 hours after the operation.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Vali-asr
Full name of responsible person
moloud farmahini
Street address
Vali-asr Str, Vali-asr Hospital
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Arak University of Medical Sciences
Full name of responsible person
Dr. Rafiei
Street address
Payambare Azam Complex, Sardasht
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
moloud farmahini
Position
MSC NURSING
Other areas of specialty/work
Street address
Department of Nursing Faculty of Nursing and Midwifery/building university Payambar Azam/Basij square
City
Arak
Postal code
Phone
+98 86 1417 3524
Fax
+98 86 1417 3524
Email
farahani91@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nursing Faculty of Nursing and Midwifery
Full name of responsible person
moloud farmahini
Position
MSC Nursing
Other areas of specialty/work
Street address
Department of Nursing Faculty of Nursing and Midwifery /Payambar Azam university complex/Basij square Arak/building university Payambar Azam/Basij square
City
Arak
Postal code
Phone
+98 86 1417 3524
Fax
+98 86 1417 3524
Email
farahani91@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Yasaman Pourandish
Position
BSN Nursing
Other areas of specialty/work
Street address
Department of Nursing Faculty of Nursing and Midwifery/Payambar Azam university complex/Basij square/Arak
City
Arak
Postal code
Phone
Fax
Email
y.pourandish@gmail.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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