The effect of Emotional Expression Technique on anxiety, heart rate, blood pressure and arterial oxygen saturation among the hospitalized elderly patients before coronary angiography
Determining the effect of emotional freedom technique on anxiety, heart rate, blood pressure and arterial blood oxygen saturation before angiography in the elderly.
Design
Parallel group randomized trial in which participants will be divided into two groups by permuted block randomization. Sample size was calculated 52.
Settings and conduct
Participants will be selected through hospitalized patients in CCU and post angiography wards of Al-Zahra Heart Hospital in Shiraz.
Before the angiography, the people in the intervention group will receive the emotion release technique for 15 minutes .Patient's level of anxiety, blood pressure، heart rate and oxygen saturation will be measured and recorded before and immediately after intervention. Patients in the control group will receive routine wards care and their level of anxiety, blood pressure، heart rate and oxygen saturation will be measured and recorded at two intervals of 15 minutes.
Participants/Inclusion and exclusion criteria
Oriented, hospitalized elderly people who are candidate for non-emergency angiography. Also elderlies who have a negative history of sedative and anti-anxiety drug use
Intervention groups
In the intervention group, before angiography, emotional freedom technique is performed for the patients and the patient's level of anxiety, blood pressure, heart rate and oxygen saturation will be checked.
The control group will receive routine care and at the same intervals that the outcome variables are measured in the intervention group, they are also measured in the control group.
Main outcome variables
level of anxiety, blood pressure، heart rate and arterial oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190727044347N3
Registration date:2021-07-13, 1400/04/22
Registration timing:prospective
Last update:2021-07-13, 1400/04/22
Update count:0
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
Fatemeh Shirazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
shirazifa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Emotional Expression Technique on anxiety, heart rate, blood pressure and arterial oxygen saturation among the hospitalized elderly patients before coronary angiography
Public title
The Effect of Emotional Expression Technique on anxiety, heart Rate, blood pressure and oxygen saturation before Coronary Angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly patients between 60 to 90 years old
People who are willing to participate in research and fill out the informed consent form
Elderly patients who are hospitalized in the cardiac care units and are candidate for non-emergency angiography or the elderly who refer to the angiography ward by prior appointment.
People who are fully aware and able to communicate
People who have not undergone other invasive procedures such as esophageal echocardiography before angiography.
People undergoing coronary angiography for the first time
Exclusion criteria:
Positive history of cognitive and psychological disorders at the time of the study based on the initial patient assessment.
Taking sedatives, anti-anxiety, anti-depressants, narcotics, corticosteroids and other drugs affecting the autonomic nervous system and endocrine system before (8 hours before angiography)
Drug addiction, sedatives and alcohol consumption.
Emergency angiography and unstable condition of the client
Having pain before angiography
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting eligible individuals to participate in the study based on inclusion criteria, these individuals will be assigned to two study groups based on double randomized permutation block with foursome blocks.
The random list is generated by a statistician using "Random Allocation" software. Foursome blocks are the combination of different status such as: ABBA, BAAB, BABA, ABAB, BBAA, AABB. Using random list that is generated by computer, blocks are selected for forming the two study groups.
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 Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.
City
ُShiraz
Province
Fars
Postal code
7134814336
Approval date
2021-05-29, 1400/03/08
Ethics committee reference number
IR.SUMS.REC.1400.209
Health conditions studied
1
Description of health condition studied
Angiography in elderlies
ICD-10 code
I97
ICD-10 code description
Intraoperative and postprocedural complications and disorders of circulatory system, not elsewhere classified
Primary outcomes
1
Description
Anxiety level
Timepoint
Before and after the intervention, (before the angiography)
Method of measurement
Spielberger State Anxiety Inventory
2
Description
The level of arterial oxygen saturation
Timepoint
Before and after the intervention, (before the angiography)
Method of measurement
pulse oximetry
3
Description
heart rate
Timepoint
Before and after the intervention, (before the angiography)
Method of measurement
Pulse oximetry
4
Description
Blood Pressure
Timepoint
Before and after the intervention, (before the angiography)
Method of measurement
blood pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one hour before angiography, the emotional freedom technique will be explained to the patients of the intervention group and they will be taught how to perform the intervention.The procedure is as follows: at each stage before the intervention, a short interview will be conducted with the patient and the unpleasant factors that cause him /her discomfort in that situation, will be determined. Then, by focusing on these unpleasant situational factors, a series of indoctrination and positive sentences are taught to the patient, and the patient tries to accept his/her problem and relax him/herself by repeating these positive and indoctrination sentences.In addition, seven positive, non-annoying blows to each of the patient's meridian points are struck by the patient himself while repeating the positive inductive sentences. The intervention group will receive the emotion release technique for 15 minutes.
Category
Treatment - Other
2
Description
Control group: The control group will receive routine care and at the same intervals that the outcome variables are measured in the intervention group, they are also measured in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Heart Charity Hospital and Shahid Hejazi Children Hospital
Full name of responsible person
Hojjatollah Roosta
Street address
Astaneh Three Ways, Sibouyeh Blvd.
City
Shiraz
Province
Fars
Postal code
71649-54937
Phone
+98 71 3739 8811
Email
hfcmanager@sums.ac.ir
Web page address
https://hfhc.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaianzadeh
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
71393613119
Phone
+98 71 3647 4254
Fax
Email
shirazi_1393@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
shirazi_1393@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
shirazi_1393@yahoo.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available