Determining the effect of aromatherapy with rose flowers on the anxiety and pain of patients before and after endoscopy urology surgery
Design
Experimental study of a three-blind clinical trial
Settings and conduct
This research is in the form of a randomized clinical trial, which will be conducted with permission from Shiraz University of Medical Sciences and receiving the code of ethics on 120 patients who are candidates for stone-breaking surgery by endoscopic method at Ali Asghar and Shahid Faqihi Hospital in Shiraz. In this study, patients were placed in two intervention and control groups through available sampling based on the selection criteria and then through random allocation through a table of random numbers.Visual Analogue Scale (VAS) and Spielberger questionnaire are used to collect data. In both groups, the intervention and control of pain and anxiety will be evaluated in three stages before aromatherapy and before and after surgery using VAS tool and Spielberger questionnaire.
The intervention in the intervention group will be carried out in three stages 6 hours before the operation and in the recovery room after the operation and 6 hours after the operation with three drops of rose essential oil on cotton at a distance of 10 cm from the patient's nose. All the above measures with distilled water in The control group will also be done and finally the results of the two groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study; enjoying mental health; hemodynamic stability; not using anti-anxiety and painkillers; olfactory health; no history of food and seasonal allergies.
Intervention groups
Patients will be randomly divided into two groups; the first group will inhale rose essence, and the second group will inhale distilled water.
Main outcome variables
Pain and anxiety before and after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100919004775N14
Registration date:2022-11-16, 1401/08/25
Registration timing:registered_while_recruiting
Last update:2022-11-16, 1401/08/25
Update count:0
Registration date
2022-11-16, 1401/08/25
Registrant information
Name
Zinat Mohebbi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
zmohebi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
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
The effect of aromatherapy with rose on anxiety and pain of patients before and after Endoscopic lithotripsy procedure
Public title
The effect of aromatherapy with rose flowers on pain and anxiety before and after surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Enjoying mental-psychological health
No hearing or speech impairment
Hemodynamic stability
Absence of chronic pain
No use of anti-anxiety and pain relievers
Olfactory health
No history of food and seasonal allergies
Exclusion criteria:
Addicted people or those who use narcotic drugs or painkillers for a long time
Patients who need medication or measures other than routine care during surgery to eliminate complications and reduce pain intensity
Expression of disapproval to continue the research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will select the samples according to the conditions of entering the study and based on the purpose, in the form of available sampling. For randomization, permutation blocks will be used to assign people to two control and intervention groups. The samples are selected from two centers and are allocated in these classes by the method of alternating blocks of samples. Based on the sample size and the number of groups, 60 people will be allocated in each group and then the samples will be allocated to 5 blocks of 6 in each center. The random allocation list is prepared by online software on the web.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the information will be informed that they will participate in a study, but they did not realize that they are in the control group or in the intervention group. The help of the researchers who conduct the intervention, I do not know which group is the experimental group, part of the group, and which group is the control group. Bottles of rose essential oil and placebo will be introduced with the help of researchers in the form of drug A and drug B. Also, helping the patients who evaluates the pain and the doctor before and after the intervention, I don't know which patient is in the intervention group and which patient is in the control group.For the one who will analyze the results, the intervention and control group will be introduced as group A and B. For the research assistant who will carry out the intervention, rose essence will be introduced as drug A and distilled water as drug B. In addition, during the study, the patients in the intervention group and the control group will be tried to be in separate rooms. On the other hand, the patients will not want to know whether they are in the control group or the control group.
Placebo
Used
Assignment
Parallel
Other design features
Experimental study of a three-blind clinical trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Faculty of Nursing and Midwifery of Shiraz University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Namazi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2022-10-08, 1401/07/16
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1401.064
Health conditions studied
1
Description of health condition studied
Pain before and after surgery
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain before and after surgery
Timepoint
6 hours before the operation - immediately after the intervention - 6 hours after the operation
Method of measurement
Visual analog Scale
2
Description
Anexiety before and after surgery
Timepoint
6 hours before the operation - immediately after the intervention - 6 hours after the operation
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:All patients will complete relevant questionnaires (demographics, pain intensity and anxiety) before aromatherapy. In the intervention group, 6 hours before the surgery, the researcher will soak the cotton with three drops of rose essential oil (provided by Barich Essential Oil Company, Kashan) and install it at a distance of 10 cm on the patient's clothes with a plastic pin, and then ask him You can breathe normally. When the patient is waiting in the operating room and in the preparation room before the operation,the severity of their pain and anxiety is also completed once again by the project partner. In the operating room, all patients are anesthetized by spinal anesthesia with Markain 10 mg and spinal needle number 25.After completing the surgery and reconnecting with the patients in the recovery room, the researcher will apply 3 drops of rose essential oil on cotton and place it on the patient's clothes at a distance of 10 cm, and he will be asked to wait for 6 Breathe normally. 6 hours after the surgery, the researcher will again measure the pain intensity and the level of anxiety of the patients using the mentioned questionnaires
Category
Treatment - Other
2
Description
Control group: All patients will complete relevant questionnaires (demographics, pain intensity and anxiety) before aromatherapy. In the intervention group, 6 hours before the surgery, the researcher will soak the cotton with distilled water and attach it to the patient's clothes with a plastic pin at a distance of 10 cm, and then he will be asked to breathe normally. When the patient is waiting in the operating room and in the preparation room before the operation, the intensity of their pain and anxiety is also completed again by the project partner.In the operating room, all patients are anesthetized by spinal anesthesia with Markain 10 mg and spinal needle number 25. After the surgery is completed and reconnecting with the patients in the recovery room, the researcher again smears the distilled water on the cotton and It will be installed on the patient's clothes at a distance of 10 cm and he will be asked to breathe normally for 6 hours. 6 hours after the surgery, the researcher will again measure the pain intensity and the level of anxiety of the patients using the mentioned questionnaires
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faqihi and Aliasghar Hospital
Full name of responsible person
Maryam Mohit
Street address
Namazi Square, School of Midwifery Nursing
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3227 9701
Email
zmohebi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roxana Ganghorban
Street address
Nursing and Midwifery College, Zand Street
City
Shiraz
Province
Fars
Postal code
13119-71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
researchnu@sums.ac.ir
Grant name
26218 25/07/1401
Grant code / Reference number
26218
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Chancellor for Research and Technology of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Mohit
Position
Surgical Technologist
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 43,Yasaman Ave,Gulf of Fars Blvd
City
Shiraz
Province
Fars
Postal code
7159764479
Phone
+98 71 3741 9784
Email
maryammohit71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Assistant Professor of Internal Surgery Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sadra - Danesh Blvd. - Eram St. - Farhang St. in front of Farhang 3
City
Shiraz
Province
Fars
Postal code
7199414477
Phone
26033641
Email
Mohebbi04@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand Street, Namazi Hospital, Nursing and Midwifery College
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4256
Email
mohebbi04@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
We do not have data yet
When the data will become available and for how long
Access period starts after publish the article
To whom data/document is available
All people
Under which criteria data/document could be used
For Operation Room Personnel
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document