The Effect of Emotional Freedom Technique on Sleep, Low Back Pain and Blood Pressure in the Elderly Patient Hospitalized After Coronary Angiogaphy in Alzahra Cardiology hospital 2020
Determining the effect of Emotional Freedom Technique on Sleep, Low Back Pain and Blood Pressure of Elderly Hospitalized Patient After Coronary Angiogaphy
Design
Parallel group randomized trial in which participants will be divided into two groups by permuted block randomization. Sample size was calculated 68.
Settings and conduct
After the angiography, the people in the intervention group will receive the emotion release technique three times, once after the angiography and immediately after the patient enters the ward, once an hour later, and the third stage at 8 pm.Patient's pain level and blood pressure will be measured and recorded before and immediately after each intervention. The next morning, a sleep quality questionnaire will be completed for patients.Patients in the control group receive routine ward care and at the same time set for the intervention group, pain level and blood pressure will be measured and recorded at two intervals of 15 minutes.
Also, before angiography and the next day after the angiography, the sleep quality questionnaire will be completed for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: oriented, hospitalized elderly people who are candidate for non-emergency angiography for the first time. Exclusion criteria: cognitive and psychological disorders; vision impairment, sleep problems and back pain; drug addiction; sedatives and narcotics abuse; active bleeding or need for cardiopulmonary resuscitation.
Intervention groups
Patients in the intervention group, after performing angiography and entering the ward, will receive the emotion release technique three times immediately after entering the ward, one hour later and at 8 pm that night.
Patients in the control group receive routine ward care.
Main outcome variables
Blood pressure; The severity of low back pain; The quality of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190727044347N2
Registration date:2021-03-14, 1399/12/24
Registration timing:prospective
Last update:2021-03-14, 1399/12/24
Update count:0
Registration date
2021-03-14, 1399/12/24
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
2021-03-21, 1400/01/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Emotional Freedom Technique on Sleep, Low Back Pain and Blood Pressure in the Elderly Patient Hospitalized After Coronary Angiogaphy in Alzahra Cardiology hospital 2020
Public title
The Effect of Emotional Freedom Technique on Sleep, Low Back Pain and Blood Pressure in the Elderly patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly Patients between 60 to 90 years old
Elderly patients admitted to the cardiac care units and candidate for non-emergency angiography
People who want to participate in research and fill out the informed consent form
People who are fully aware and able to communicate
People who have not undergone other invasive procedures such as esophageal echocardiography before angiography.
Elderlies who have only angiography and do not have right heart catheterization
People undergoing coronary angiography for the first time
Exclusion criteria:
Having positive history of sleep disorders and taking medication before hospitalization based on the initial patient assessment form.
Having known cognitive and psychological disorders at the time of the study based on the initial patient assessment form.
Taking sedatives and analgesics before (8 hours before) and after angiography
The need for cardiopulmonary resuscitation during angiography.
Having visual impairment that prevents the selection of the correct position in the pain assessment tool (based on the initial patient assessment form).
Having active hemorrhage with hemodynamic disorders that resulted in blood transfusion during and after angiography.
Dangerous rhythm disorder immediately after catheterization.
Having low back pain on admission.
Addiction to drug, sedatives and alcohol drinks.
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:
68
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
Research 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
2020-12-26, 1399/10/06
Ethics committee reference number
IR.SUMS.REC.1399.1023
Health conditions studied
1
Description of health condition studied
Hospitalized elderlies after angiography
ICD-10 code
I97
ICD-10 code description
Intraoperative and postprocedural complications and disorders of circulatory system, not elsewhere classified
Primary outcomes
1
Description
The quality of sleep
Timepoint
The beginning of the study (before the intervention) and the day after the intervention
Method of measurement
The St. Mary's Hospital Sleep Questionnaire (SMHS)
2
Description
Low Back Pain
Timepoint
Patients' low back pain is measured before and after the three times intervention . The intervention will be performed once immediately after the patient enters the ward, once an hour later and the third stage will be performed at 8 pm on the same night. Patients in the control group at the same times set for the intervention group, the level of pain will be measured and recorded in two time intervals with an interval of 15 minutes.
Method of measurement
Visual scale for pain intensity
3
Description
Blood Pressure
Timepoint
Patients' blood pressure is measured before and after the three times intervention. The intervention will be performed once immediately after the patient enters the ward, once an hour later and the third time will be performed at 8 pm on the same night. ّIn the control group at the same times set for the intervention group, blood pressure will be measured and recorded in two time intervals with an interval of 15 minutes.
Method of measurement
Digital model amron 3 blood pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 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 is conducted with the patient and the unpleasant factors that cause him 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 problem and relax himself 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 therapist or the patient himself while repeating the positive inductive sentences. The intervention group will receive the emotion release technique three times ،In this way, this technique will be performed once after angiography and immediately after the patient enters the ward. The second stage is the intervention one hour after the patient enters the ward and the third stage will be done at 20:00 that night.
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
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Heart Charity Hospital and Shahid Hejazi Childrenl and Hejazi Children Hospital
Full name of responsible person
Dr 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/?sub=51
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
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://research.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 Square
City
Shiraz
Province
Fars
Postal code
71393613119
Phone
+98 71 3647 4254
Fax
+98 71 1647 4252
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 Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
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 Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
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