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Comparing the Effect of aromatherapy with Geranium Essence and Lemon on situational anxiety and physiologic indexes of patients after coronary angioplasty

Protocol summary

Study aim
Comparison of effect of aromatherapy with geranium and lemon essential oil on situational anxiety and physiological parameters of patients after coronary angioplasty
Design
This is a clinical trial study with control group, with parallel groups, double-blind, randomized, phase 3 on 150 patients. Patients are randomly assigned to three groups (1, 2, and 3) by a random allocation concealment method without any comments. To perform the intervention, researcher pours three drops of geranium essential oil, three drops of lemon essential oil and three drops of placebo or sweet almond oil on a cloth and attaches it to the shirts of the subjects in the desired groups to perfume patients for 20 minutes. Expose to inhalation. After 20 minutes, situational anxiety questionnaire is completed again by samples and physiological indicators are measured.
Settings and conduct
This research will be performed in Shahid Chamran Hospital in Isfahan, is a double-blind study in which essential oil and control bottles are covered with black tape, the type of which is unknown to health care providers and patients.
Participants/Inclusion and exclusion criteria
The study population includes all patients who undergo coronary angioplasty in Shahid Chamran Hospital in Isfahan. Inclusion criteria: Willingness to participate in study, Ability and willingness to complete the questionnaire non-Inclusion criteria: history of allergies, use of painkillers or anti-anxiety drugs before the study, Existence of hearing, olfactory and mental problems, Existence of acute and chronic mental illnesses
Intervention groups
We have 3 groups: geranium essential oil (group 1), lemon essential oil (group 2) and control group (sweet almond oil - group 3). The essential oil and control bottles will be covered with black tape and its type is unknown to healthcare provider.
Main outcome variables
Situational anxiety, physiological parameters

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201209049662N1
Registration date: 2020-12-25, 1399/10/05
Registration timing: retrospective

Last update: 2020-12-25, 1399/10/05
Update count: 0
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
Maryam Asadi Mobarakeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 564 3134
Email address
maryamasadii@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-21, 1399/04/31
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
2020-07-21, 1399/04/31
Actual recruitment end date
2020-10-21, 1399/07/30
Trial completion date
2020-10-22, 1399/08/01
Scientific title
Comparing the Effect of aromatherapy with Geranium Essence and Lemon on situational anxiety and physiologic indexes of patients after coronary angioplasty
Public title
Effect of aromatherapy situational anxiety and physiologic indexes of patients after coronary angioplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Ability and willingness to complete the questionnaire Have not undergone other invasive procedures such as esophageal echocardiography before angioplasty. Everyone is fully conscious and not in a critical condition
Exclusion criteria:
Use painkillers or anti-anxiety medications before the study Existence of hearing, olfactory and mental problems Existence of acute and chronic mental illnesses History of allergy to the geranium plant or extract and lemon fruit or extract Postoperative complications (severe pain, active bleeding or infection)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 150
Actual sample size reached: 150
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, no patient will be aware of their group and a random sequence will be performed, and the method of using randomly coded boxes will be used. In this method, a number of boxes selected by the researcher as the first group and the same number of boxes for the next groups are considered; Then, by merging the boxes together, a box is taken out and its allocation is recorded, and that box is returned to the other boxes after being taken out. The boxes are then reassembled and another box is removed. This process continues until a random sequence according to the sample size is reached. Thus, patients will be divided into three groups: geranium essential oil (group 1), lemon essential oil (group 2) and control group (sweet almond oil - group 3).
Blinding (investigator's opinion)
Double blinded
Blinding description
Essential oil and control bottles will be covered with black tape and its type is unknown to healthcare providers and patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University - Isfahan (Khorasgan) Branch
Street address
University Blvd, Arqavanieh, East Jey street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.132

Health conditions studied

1

Description of health condition studied
Coronary angioplasty
ICD-10 code
Z98.61
ICD-10 code description
Coronary angioplasty status

Primary outcomes

1

Description
Situational Anxiety
Timepoint
Before and 20 minutes after the intervention
Method of measurement
Spielberger Standard Situational Anxiety Questionnaire

2

Description
Physiological indicators
Timepoint
Before and 20 minutes after the intervention
Method of measurement
Checklist of physiological parameters of patients including systolic and diastolic blood pressure, respiratory rate, pulse rate and arterial oxygen saturation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Geranium Essence. The geranium essential oil used in this study was prepared by Tabib Daroo Company and according to the essential oil analysis sheet prepared by Tabib Daroo Company, this essential oil contains alphapinene (1.35%), citronellol (37.53%), geraniol (7.2%). And citronel formate (10.03%). To perform the intervention, the researcher pours three drops of geranium essential oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and physiological parameters are measured.
Category
Treatment - Drugs

2

Description
Intervention group2: Lemon Essence. The essential oil of lemon used in this study was prepared by Tabib Daroo Company and according to the essential oil analysis sheet prepared by Tabib Daroo Company, this essential oil contains limonene (51.75%), betapinene (6.83%), terpinoline (5.16%). And alphapinene (2.45%). To perform the intervention, the researcher pours three drops of lemon essential oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and physiological parameters are measured.
Category
Treatment - Drugs

3

Description
Control group: Sweet almond oil. To perform the intervention, the researcher pours three drops of sweet almond oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and the physiological parameters are measured. The control group did not receive any intervention and is cared for according to the usual care of the ward.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran Heart Educational, Therapeutic and Research Center
Full name of responsible person
Gholamreza Massoumi
Street address
Mushtaq II Street
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
chamran@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Payam Najafi
Street address
University Blvd, Arqavanieh, East Jey street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3535 4001
Email
p.najafi@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Maryam Asadi Mobarakeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO.45, Aria Building, Shahid Zahraei Alley, Artesh street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3620 0409
Email
maryamasadii@khuisf.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Asadi Mobarakeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO.45, Aria Building, Shahid Zahraei Alley, Artesh street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3620 0409
Email
maryamasadii@khuisf.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Asadi Mobarakeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO.45, Aria Building, Shahid Zahraei Alley, Artesh street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3620 0409
Email
maryamasadii@khuisf.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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