Comparison of the effect of aromatherapy with Damask rose and chamomile essential oil on anxiety level, pain intensity and hemodynamic variables in patients candidates for emergency surgery.
Design
This study will be a randomized clinical trial with three groups (two intervention groups and one control group).To allocate the samples to the study groups randomly, the random permutation block design of three treatments with six blocks will be used; which will be considered A (for the frozen flower group), B (for the chamomile group) and C (for the control group). Then the website https://www.sealedenvelope.com will be used to determine the required random blocks and their sequence.
Settings and conduct
The research environment will be the male and female surgery wards of Zanjan medical science teaching hospitals.
Participants/Inclusion and exclusion criteria
People over 18 years of age (to ensure the expressed sense), The patient's desire to participate in the study, Having clear verbal ability, Not having a history of allergy and sensitivity to chamomile and Damask rose, Having a healthy sense of smell and Having no history of surgery on the jaw, face and nose and systemic or chronic diseases affecting the sense of smell or hearing, There is no history of mental illness and chronic anxiety diseases known based on the patient's speech and his family.
Intervention groups
Aromatherapy group with Damask rose essential oil (group A) - Aromatherapy group with chamomile essential oil (group B) - Control group with distilled water (group C)
Main outcome variables
Anxiety; Pain; Vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220827055802N1
Registration date:2022-09-14, 1401/06/23
Registration timing:prospective
Last update:2022-09-14, 1401/06/23
Update count:1
Registration date
2022-09-14, 1401/06/23
Registrant information
Name
Farshid Bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3575 4193
Email address
farshidbh72129@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of aromatherapy with Chamomile and Damask Rose (Rosa damascene mill) on anxiety and pain in emergency surgery patients
Public title
Comparison between the effect of aromatherapy with Chamomile and Damask Rose (Rosa damascene mill) on anxiety and pain in emergency surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- People over 18 years of age (to ensure the expressed sense)
2- The patient's desire to participate in the study
3- Having clear verbal ability
Exclusion criteria:
1- having a history of allergy and sensitivity to chamomile and Damask Rose
2- There is history of mental illness and chronic anxiety diseases known based on the patient's speech and his family.
3- Unhealthy sense of smell and having a history of surgery on the jaw, face and nose and systemic or chronic diseases affecting the sense of smell or hearing
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate the samples to the study groups randomly, a random permutation block design of three treatments with six blocks will be used, which is A (for the Damask Rose group), B (for the chamomile group) and C (for the control group ) will be considered. Then, the website: https://www.sealedenvelope.com will be used to determine the required random blocks and their sequence.
Blinding (investigator's opinion)
Not 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 Zanjan University of Medical Sciences
Street address
No 73-beheshti street- hidaj city-zanjan province
City
Zanjan
Province
Zanjan
Postal code
4573155641
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.ZUMS.REC.1401.183
Health conditions studied
1
Description of health condition studied
All candidates for emergency surgery in the field of orthopedics with a closed injury of a limb, such as fractures and sprains, tendon injuries, and joint and ligament injuries in the hands or feet.
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Anxiety level on the visual analogue scale of anxiety
Timepoint
Measuring the level of anxiety before the intervention, after three intervention periods, in the morning before the operation
Method of measurement
Visual Analogue Scale of Anxiety
2
Description
Pain intensity on a visual analog scale
Timepoint
Pain intensity measurement before the intervention, after three intervention periods, in the morning before the operation
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Vital Signs
Timepoint
Before and after performing 3 intervention courses and on the morning of the operation day while transferring the patient to the operating room
Method of measurement
A nurse will be used to count the patient's breaths in one minute. For pulse and blood pressure, the standard portable monitor device calibrated by the medical equipment unit of the hospital will be used by the same nurse
Intervention groups
1
Description
The first intervention group: Damask rose group, the use of 40% Damask rose essential oil as aromatherapy, the total time of the intervention at the night before the operation is 3 times each time for 1 hour, with 3 drops in each hour and a total of 9 drops in 3 hours. The essential oil purchased from Zarband company will be used
Category
Treatment - Drugs
2
Description
The second intervention group: Chamomile group, the use of 40% Chamomile essential oil as aromatherapy, the total time of the intervention at the night before the operation is 3 times each time for 1 hour, with 3 drops in each hour and a total of 9 drops in 3 hours. The essential oil purchased from Zarband company will be used
Category
Treatment - Drugs
3
Description
Control group: Distilled water group, use of distilled water as aromatherapy, the total time of the intervention the night before the operation is 3 times for 1 hour each time, where 3 drops will be used every hour and a total of 9 drops will be used in 3 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational & Treatment Center of valiasr
Full name of responsible person
Dr. Hassan Nishaburi
Street address
Hazrat Valiasr (PBUH) Medical Education Center, Above Valiasr Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۵۷۷۷۹۷۸
Phone
+98 24 3377 0801
Fax
+98 24 3377 0751
Email
valiasr@zums.ac.ir
Web page address
https://zums.ac.ir/
2
Recruitment center
Name of recruitment center
Alghadir Abhar Hospital
Full name of responsible person
Dr. Javad Hosseinkhani
Street address
next to the nursing faculty, Nurse Blvd, at the end of Ayatollah Khamenei Blvd, Abhar city
City
Abhar
Province
Zanjan
Postal code
۴۵۶۱۷۸۹۳۹۱
Phone
+98 24 3536 8200
Fax
+98 24 3536 8210
Email
alghadir@zums.ac.ir
Web page address
https://zums.ac.ir/index.php?slc_lang=fa&sid=216
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Hassan Bakhtiari
Street address
Zanjan University of Medical Sciences, Azadi Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۵۶۱۳۱۹۱
Phone
+98 24 3315 6141
Fax
+98 24 3342 0460
Email
research@zums.ac.ir
Web page address
https://zums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Nasreen Hanifi
Position
Associate professor, faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, Shahrak karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
nasrinhanifi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Nasreen Hanifi
Position
Associate professor, faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, Shahrak karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
nasrinhanifi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Nasreen Hanifi
Position
Associate professor, faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, Shahrak karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
nasrinhanifi@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD