Assessing the effect of Reiki exercises on pain in the sternotomy area and hemodynamic parameters of patients after CABG surgery
Design
A clinical trial with an intervention and control group, with parallel group, without blinding, there is no trial phase, simple randomization method is used for randomization.
Settings and conduct
Place of study; Open Heart Surgery Department of Imam Reza Hospital (AS), for the intervention group; In addition to routine treatment (Apotel drug), Reiki stage 1 is performed for patients, and pain measurement and hemodynamic parameters are performed before and after the intervention for the control and intervention groups. The control group receives only routine treatment and no intervention is performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria
: age 18 to 70 years, Persian speaking and the ability to read and write, willingness to participate in the study.
Exclusion criteria:
Failure to cooperate in all stages of the study or in case of unexpected complications
Intervention groups
The direction of the intervention group; In addition to routine treatment (Apotel drug), Reiki stage 1 is performed for patients, and pain measurement and hemodynamic parameters are performed before and after the intervention for the control and intervention groups. The control group receives only routine treatment and no intervention is performed.
Main outcome variables
Pain and Hemodynamic Parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230901059315N1
Registration date:2023-09-12, 1402/06/21
Registration timing:prospective
Last update:2023-09-12, 1402/06/21
Update count:0
Registration date
2023-09-12, 1402/06/21
Registrant information
Name
Sara Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 7629
Email address
ahmadis4002@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Reiki practice on sternotomy incision pain and hemodynamic criteria after CABG
Public title
Investigating the effect of energy therapy on pain and vital signs of patients after open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A patient who is a candidate for heart surgery who needs coronary artery bypass surgery. Age 18 to 70 years, Persian speaking ability and ability to read and write, awareness of time and place, not having concomitant diseases that affect the perception of pain (such as diabetes).
Exclusion criteria:
Failure to cooperate in all stages of the study or in case of unexpected complications.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
randomization method and its explanation: simple randomization; Study participants are randomly divided into control and intervention groups.
Randomization Unit: Parallel
Randomization layers: None
Allocation concealment method: simple randomization
How to make a random sequence: simple random
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 Mashhad University of Medical Sciences
Street address
No. 30, Aboreihan Bironi Ave., Shahid Aldaghi Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613954913
Approval date
2023-07-25, 1402/05/03
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.067
Health conditions studied
1
Description of health condition studied
sternotomy incision pain and hemodynamic criteria after CABG
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain and hemodynamic parameters
Timepoint
Pain measurement and hemodynamic criteria are done at the beginning of the study (before the intervention) and every 12 hours for 3 days after the intervention.
Method of measurement
Visual Analogue Scale and Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention method: researcher for the intervention group; The researcher first intends to perform Reiki by putting his hands on the heart for the intention and the sentences he says to himself during the intention have the meaning that we want divine energies to flow, so (for example) the researcher during the intention these sentences with He himself says: [I ask the divine energies to flow in me in the most powerful, most blessed and beautiful way and make me a channel of energy, I thank God for helping me in this process and I guides, I am grateful to the Reiki masters and guides, I am grateful to myself, and because we do Reiki for another person, we also thank that person]; Also, to make sure that Reiki flows in our palm; We press the intersection of the index finger and the thumb, then for 15-30 minutes standard Reiki exercises on 27 points with respect to Reiki level 1 (doing exercises for yourself and others at a close distance) by placing the hands at a distance (angle placement) The hands are not important and can be in any shape) on the selected areas in order: The middle of the forehead (it is called the third eye chakra, which is the place where a person communicates with himself), temples, ears, crown chakra, throat chakra, thymus, lungs, heart chakra from the front and back, hands, solar plexus chakra (points around the navel), then the points of the thighs, separately or together, knees, legs, ankles and the last part of the soles of the feet, the area of the kidneys in any position that is more comfortable for the patient and on each point for 1-2 minutes He repeats affirmative sentences with himself, the content of which is gratitude to the cells (I thank you cells for serving my body for years, You are fresh, energetic and healthy and any other positive words) and finally on mid-sternal incision according to the Reiki protocol for 2 minutes in addition to the selected points every 12 hours, at least 4 hours after receiving Apotel, days 4 to 6 after the operation in the open heart surgery department of the hospital Imam Reza will be performed for 3 days along with pain measurement and previous hemodynamic criteria, at least 10 to 15 minutes and finally one hour after Reiki.
Category
Other
2
Description
Control group: Control group: The control group does not receive any intervention and the usual pain control methods in the hospital (Apotel 150 mg) are performed for them. The intervention will be evaluated.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Nazila Zarghi
Street address
No. 30, Aboreihan Bironi Ave., Shahid Aldaghi Blvd., Sabzevar Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9613954913
Phone
+98 51 4422 7629
Email
ZarghiN@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nazila Zarghi
Street address
No. 30, Aboreihan Bironi Ave., Shahid Aldaghi Blvd., Sabzevar Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9613954913
Phone
+98 51 4422 7629
Email
ZarghiN@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nazila Zarghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Khorasan Razavi, Azadi Square, east gate of Ferdowsi University of Mashhad, university campus, educational complex of Shahid Dr. Kharazmi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3189 2105
Email
ZarghiN@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nazila Zarghi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Khorasan Razavi, Azadi Square, east gate of Ferdowsi University of Mashhad, university campus, educational complex of Shahid Dr. Kharazmi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3189 2105
Email
ZarghiN@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nazila Zarghi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Khorasan Razavi, Azadi Square, east gate of Ferdowsi University of Mashhad, university campus, educational complex of Shahid Dr. Kharazmi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3189 2105
Email
ZarghiN@mums.ac.ir
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
The pain level of the patient before and after the intervention, respectively: the first 12 hours, the second 12 hours, the third 12 hours
The amount of changes in the hemodynamic parameters of the patients before and after the intervention, respectively: the first 12 hours, the second 12 hours, the third 12 hours.
Individual information (individual data) of patients is not displayed.
When the data will become available and for how long
Maximum 2 months
To whom data/document is available
Researchers working in academic and practical institutions
Under which criteria data/document could be used
Under the conditions specified by the researcher and with his permission, they can use the documents
From where data/document is obtainable
They can interfere with the performer: Sara Ahmadi
Contact number: 09368300995
What processes are involved for a request to access data/document
After coordination with the researcher and if the researcher gives permission to use the study documents