Compare the effect of aromatherapy with lavender and Benson relaxation technique on anxiety in patients with acute coronary syndrome
Design
Three groups clinical trials, With a control group, Randomized by senary random block with no permutations with 66 patient
Settings and conduct
96 Patients referring to the cardiac care units of the Rasoul-e-Akram hospitals in Tehran and 15 khordad in Varamin, through continuous sampling will enter to study. Aromatherapy group individuals will inhale the fragrance of two drops of lavender, 2% smeared on 10-10 g of gas for 20 minutes at a distance of 5 cm from the nose. The Benson relaxation method will be performed by the patient on the day after the training. Interventions will take place for two consecutive days. All groups will receive regular care of the unit. The Spielberger anxiety inventory questionnaire will be completed before and immediately after each intervention by the researcher's assistance and by interviewing the participant samples.. Finally, the data collected will be analyzed.
Participants/Inclusion and exclusion criteria
Entrance criteria:
1- Diagnosis of acute coronary syndrome
2- 24-48 hours passed from the time they began to be hospitalized
3- Understanding and speaking in Farsi
4- 18 years of age or older
Non entrance criteria:
1- history of allergies, Eczema and allergy to herbal medicines and essential oils according
2- olfactory defects and respiratory illnesses
3- having known psychiatric or anxiety disorders
4-perform Surgical or therapeutic interventions on the day of intervention
5- hearing problems
6-having muscle paralysis
7- addiction to drugs and alcohol
8-Patient expression from having anxiety
Intervention groups
Three groups of aromatherapy, Benson's muscle relaxation and control
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160704028781N3
Registration date:2018-04-28, 1397/02/08
Registration timing:prospective
Last update:2018-04-28, 1397/02/08
Update count:0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Farshad Heidari Beni
Name of organization / entity
Iran Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 38 3372 3354
Email address
heydari-bani.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of aromatherapy with lavender and Benson relaxation technique on anxiety in patients with acute coronary syndrome
Public title
Comparative study of the effect of aromatherapy with lavender and Benson relaxation technique on anxiety in patients with acute coronary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of acute coronary syndrome by a cardiologist
24-48 hours from the time they began to be hospitalized
Understanding and speaking in Farsi to provide contact with the patient
18 years of age or older
No history of allergies, Eczema and allergy to herbal medicines and essential oils according to the patient's self-report
No olfactory defects and respiratory illnesses, such as asthma according to patient's self-report
Failure to have known psychiatric or anxiety disorders according to self-report and examination of the patient's file
Failure to perform Surgical or therapeutic interventions such as angiography on the day of intervention
No hearing problems according to patient's self-report
not having muscle paralysis according to patient's self-report
non-addiction to drugs and alcohol according to patient's self-report
expressing patient from having anxiety
Exclusion criteria:
Patient's death
Any symptoms of allergy, pain, shortness of breath or disorientation during the intervention
Transferring the patient from the cardiac care unit to another section
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocating samples to the groups will be in a random senary blocked without permutation (16 senary blocks from 96) of each center. In this sampling method, different modes of the three groups using the random numbers table are written on six cards, each card will be placed in an envelopes. These envelopes are placed in a box and the researcher does not know which groups of research will be selected before choosing the card. The statistician (unaware of the study and the groups) identifies with the removal of one of the envelopes from the box, which of the three patients included in the study will fall into the groups, respectively. The process continues to remove all 6 cards from the box, and again the cards are returned to the box, and this random selection is repeated to provide the desired sample size.
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 Iran Medical Sciences University of Medical Sciences
Street address
Iran University of Medical Sciences. Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-03-27, 1397/01/07
Ethics committee reference number
IR.IUMS.REC 1396.9511449006
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Anxiety: Anxiety is an unpleasant mental sensation, discomfort and tension. The meaning of anxiety in this study is a score that patients receive from the Spielberger questionnaire.
Timepoint
The Spielberger anxiety inventory questionnaire will be completed before and immediately after each intervention by the researcher's assistance and by interviewing the participant samples
Method of measurement
The Spielberger anxiety inventory questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Aromatherapy with lavender:Our point is an aroma of lavender extract in the form of an inhaler, in which people will be asked to smear two drops of 2% lavender smeared on 10-10 cm of gas and inhale it for at least 5 cm distance from the nose for 20 minutes.Patients will do this action Once a day, between 18:00 and 18:00 for two consecutive days.
Category
Rehabilitation
2
Description
Intervention group 2: Benson relaxation technique: The Benson's muscle relaxation is performed by the patient in six steps. 1- Stay in a comfortable position 2. Close eyes. 3. Expansion the muscles of the body from the tip to the head 4. Performing the inhale through the nose and exhaling through the mouth and whisper the word desired when exhaling. 5- Perform the above steps for 20 minutes, then open the eyes and do not move for a few minutes. 6. Lack of worry and ignoring disturbing thoughts during relaxation. During the intervention, remove the disturbing thoughts from your mind as much as possible and choose a word that has always reminded him of calm, such as (God, love, sea). Instructions for doing these steps will be provided through the MP3 player and headphones. In this audio file, the instructions are set for 20 minutes and there is no need to set the clock to determine the method duration. In this file, 30 seconds before the completion of the technique, a gentle song will be put to inform the patient about the end of the procedure. To perform muscle relaxation by pulling the curtains at the patient's bed, the patient's privacy is observed and the privacy of the person and providing a quiet and silent environment for sitting with the department's officials is coordinated so that nobody gets into the patient's unit. One day after training the procedures In addition to the usual care of the department, Benson's relaxation procedure is performed once a day between the hours (18-20) for two consecutive days by patients and supervised by the researcher.
Category
Rehabilitation
3
Description
Control group: Patients in the control group receive regular care. They are asked to stay on their bed for 20 minutes. Then, the Spielberger Anxiety Inventory will be completed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram hospital
Full name of responsible person
Samaneh Sahraei
Street address
Corner of Mansouri Street - Niayesh St. - Sattarkhan - Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 8805 2248
Email
nsahraea@gmail.com
2
Recruitment center
Name of recruitment center
Shohada 15 khordad
Full name of responsible person
Samaneh sahraei
Street address
Not reaching Valiasr Square - Varamin
City
Varamin
Province
Tehran
Postal code
1449614535
Phone
+98 21 3623 4923
Email
nsahraea@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakooti
Street address
Iran Univercity of Medical Science, Shahid Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Samaneh Sahraei
Position
Post Graduate Student in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Shahid Rashid Yasemi Street, Valiasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8888 2886
Email
nsahraea@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Najafi Ghezeljeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Shahid Rashid Yasemi St, Vali Asr St,Tehran
City
Tehran
Province
Tehran
Postal code
1۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
nsahraea@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samaneh Sahraei
Position
Post Graduate Student in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi St, Vali Asr St,Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
nsahraea@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
General data such as demographic variables and outcomes under study will be published.
When the data will become available and for how long
Get started 6 months after printing results
To whom data/document is available
All researchers working in academic and scientific institutions who want the results of the study will be allowed to receive the data.
Under which criteria data/document could be used
Data can be used to enhance science and use results in research.
From where data/document is obtainable
School of Nursing & Midwifery, Rashid Yasemi St, Vali Asr St,Tehran
00982143651000
nsahraea@gmail.com
What processes are involved for a request to access data/document
Once requested, the data will be delivered electronically or in person within one week.