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The effect of emotional freedom technique (EFT) on pain intensity and fatigue in patients with rheumatoid arthritis

Protocol summary

Study aim
Determining the effect of emotional release technique (EFT) on pain intensity and fatigue in patients with rheumatoid arthritis
Design
The sample size is 82 41 intervention people and 41 control people with random block method
Settings and conduct
A randomized controlled clinical trial Rheumatology department of Ahvaz Golestan Hospital or rheumatology clinic or rheumatologist's office Implementation at home or hospital twice a week, 30 minutes each time, during 4 weeks and a total of 8 sessions
Participants/Inclusion and exclusion criteria
Inclusion criteria Not having speech, hearing, and movement disorders Not using other complementary and alternative treatments Absence of injuries and wounds in the desired points of acupuncture Age 18 to 65 years Exclusion criteria Patient death during the study Failure to complete questionnaires Simultaneous participation in similar educational programs
Intervention groups
In this technique, using the 2 index and middle fingers of the dominant hand on the points including (point ST14 in acupuncture), head (DU20), eyebrow (BL2), side of the eye (GB1), under the eye (ST1), under the nose (GV26) ), chin (CV24), lower border of clavicle (KD27), armpit (SP21), margin between thumb and outer corner of nail (LU11), index finger (LI 1), middle finger (PC9), little finger (HT9) And karate point (SI 3) and Gamut point (TH3 acupuncture point located on the back of the hand between the ring finger and the little finger on the metacarpal bone) are hit. This intervention is repeated for 30 minutes. In the control group, no special action will be taken.
Main outcome variables
Reducing the intensity of pain and fatigue in patients with rheumatoid arthritis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230724058904N1
Registration date: 2023-07-28, 1402/05/06
Registration timing: prospective

Last update: 2023-07-28, 1402/05/06
Update count: 0
Registration date
2023-07-28, 1402/05/06
Registrant information
Name
sara Faramarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3225 7028
Email address
sara.faramarzi.1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emotional freedom technique (EFT) on pain intensity and fatigue in patients with rheumatoid arthritis
Public title
The effect of emotional freedom technique (EFT) on pain intensity and fatigue in patients with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not having speech, hearing, and movement disorders Not experiencing severe stress such as the death of relatives and loved ones or divorce in the last 6 months Not having obstructive airway disorders such as apnea and chronic obstructive pulmonary disease Absence of injuries and wounds in the desired points of acupuncture
Exclusion criteria:
Having mental problems, blindness, deafness or a history of psychological problems Incomplete completion of the demographic information questionnaire Unwillingness and lack of cooperation to participate in the study Alcohol and drug addiction Participation in pain and fatigue coping courses and other complementary courses before entering the study Age less than 18 years or more than 65 years Lack of literacy Musculoskeletal and neurological problems Existence of wound - injury and dressing in the place of the desired points to implement the technique Lack of proficiency in Persian language
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, based on the results of previous studies and according to the opinion of the esteemed consultant of statistics and methodology, the number of samples will be 82 people, and random block method will be used for randomization, and people will be randomly divided into two groups (intervention group) and (group control) are placed and blocks of 4 are used. In this way, a card will be awarded to each person who has the conditions to enter the study ̨ in chronological order upon entering the study. Then, by merging the cards together (hitting the cards), one card is removed and its assignment is recorded and a number is assigned to it. And after that card is taken out, it is returned to the pool of other cards. After assigning numbers to each card in the order of choosing the cards, each person and number will be placed in groups A and B respectively. In this way, the first person is placed in group A - the second person is placed in group B - the third person is placed in group A and .... and this process continues until 82 patients are included in a random list of people. In order to block the samples under the supervision of a statistical consultant and based on the random sequence of the cards and according to the number of permutations of 4 ̨ random selection process by placing these permutations (6 cards) ̨ in the form of cards (AABB), (ABAB), (BABA), (BBAA), (ABBA) and (BAAB)) are considered. In this way, by merging the cards together again (hitting the cards), a card is removed every time until a group of 4 cards is created, which must include two A cards and two B cards. Then each card after being removed is returned to the pool of other cards. Finally, each block is placed in the intervention group and the control group in the chronological order created. Block 1 is the intervention group, Block 2 is the control group, and Block 3 is the intervention group, and this process will continue until 82 patients are allocated treatment. In this way, the samples eligible to enter the study were selected and randomly placed in two intervention groups (41 people) and control (41 people).
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 Jundi Shapur Ahvaz University of Medical Sciences
Street address
: Ahvaz - Golestan Boulevard, University City, Esfand St., Jundishapur University of Medical Sciences, Ahvaz
City
َAHVAZ
Province
Khouzestan
Postal code
15794- 61357a
Approval date
2023-07-24, 1402/05/02
Ethics committee reference number
IR.AJUMS.REC.1402.264

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M13.0
ICD-10 code description
Polyarthritis, unspecified

Primary outcomes

1

Description
pain intensity
Timepoint
4 weeks after the intervention
Method of measurement
Brief Pain Questionnaire

2

Description
Fatigue intensity
Timepoint
4 weeks after the intervention
Method of measurement
Multidimensional fatigue measurement questionnaire

Secondary outcomes

1

Description
Pain interference in daily activities
Timepoint
4 weeks after the intervention
Method of measurement
Brief Pain Questionnaire

Intervention groups

1

Description
Intervention group: After coordinating the day and time of the session, the selected samples in the intervention group are gathered in a suitable classroom with communication facilities, and they are asked to maintain the peace of the educational environment as much as possible during the session. The EFT intervention will be done in a group in a quiet room with proper light and temperature, free from environmental stimuli. The participants will be asked to complete a brief pain questionnaire and a multidimensional fatigue measurement questionnaire as a pre-test. Then the researcher will start the emotional release technique session by showing images of the desired areas for stimulation to the people of the intervention group and they will be told how to gently pressurize the desired points using the index and middle fingers, and how to do this, he will show the steps of EFT tapping on the body (face and trunk) and ask the people to tap on their body. The practice continued until everyone learned how to perform EFT and each participant was taught individually. The duration of the training of the experimental group will be 35 minutes on average.This technique will be implemented based on the basic instructions of Gary EFT. In this technique, people are asked to think about their mental workload, fatigue and pain, check the severity of their problem and give them a score between 1 and 10. Then, using the 2 index and middle fingers of your dominant hand, hit the points around your face and upper body seven times and stimulate these points. At the same time, while hitting the points loudly, say the sentences that indicate his basic problems and the pain and fatigue that the person is experiencing, together with the sentences that indicate the acceptance of these problems. In this stage (adjustment stage), the patient says: 'Although I feel tired and in pain, I accept my body and myself completely and deeply.' He repeats this sentence three times and at the same time, massages the pain point (ST14 point in acupuncture) with a radius of 5 cm. In the recall stage, 13 acupuncture points including the head (DU20), eyebrow (BL2), near the eye (GB1), under the eye (ST1), under the nose (GV26), chin (CV24), below the border of the clavicle (KD27), armpit (SP21), the border between the thumb and the outer corner of the nail (LU11), the index finger (LI 1), the middle finger (PC9), the little finger (HT9) and using the tip of the index finger and the middle finger, hit the karate point (SI 3) hits At the same time, the patient repeats the phrase 'I'm tired and I feel pain', focusing on the fatigue and pain. At Gamut stage 9, tap the Gamut point (the TH3 acupuncture point on the back of the hand between the ring finger and little finger on the metacarpal bone). At the same time, the patient must perform 9 brain stimulation movements. These movements include: closing the eyes, opening the eyes, looking down and right, looking down and left, rotating the eyes clockwise, rotating the eyes counterclockwise, humming the desired song for 2 seconds, counting numbers from 1 to 5 and again humming the desired song for 2 seconds. In the last step, the second step is repeated. This intervention is repeated for 30 minutes. After hitting again, he will check the severity of his problems (fatigue and pain) and give them a score from 1 to 10. This technique will be repeated until the severity of the problems reaches zero. After a visual presentation about the technique, people's questions about EFT will be answered. This training will continue until all patients learn how to apply EFT. Also, each participant will be taught individually how to implement the technique. Practice will continue until all participants learn how to perform the technique. The training of each intervention group lasts an average of 30 minutes. Then the researcher asks the patients to do this technique individually at home or in the hospital twice a week, 30 minutes each time, for 4 weeks and a total of 8 sessions, and explains that to ensure the correct implementation of the technique by the person ̨ reminding them to do EFT twice a week and do their homework ̜ he calls them twice a week and answers them if there are any questions. Also, patients are asked to meet the researcher in person once a week, if possible, so that the correct way of performing the technique can be checked more closely. Then (at the end of 8 sessions), the brief pain questionnaire and the multidimensional fatigue measurement questionnaire will be given to the members of the intervention group in writing and in the presence of the researcher or as an alternative method in the form of an electronic questionnaire, and the post-test will be taken.
Category
Rehabilitation

2

Description
Control group: Control group: In the control group, no special action will be taken and to prevent these people from contacting the intervention group in order to prevent the effect of the emotional release technique on the patients of the control group, if the patients of the two groups are in the same room, they will be excluded from the study. After the end of the 8 sessions of technique implementation in the intervention group, the people of the control group will also be contacted to complete the brief pain questionnaire and the multi-dimensional fatigue measurement questionnaire as a post-test. And at the end of the study, each of the people in the control group will be taught how to perform EFT.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology department of Ahvaz Golestan Hospital or referred to Rheumatology clinic or rheumatolog
Full name of responsible person
Dr. Shaiste Haghighi
Street address
Ahvaz Golestan - Farvardin St. - Golestan Educational and Medical Center
City
AHVAZ
Province
Khouzestan
Postal code
۶۴۴۱۹۴۵۷۸۱
Phone
+98 61 3320 4501
Fax
+98 61 3337 4058
Email
golestanjpspital@yahoo.com
Web page address
https://hgolestan.ajums.ac.ir/fa-IR/hgolestan.ajums.ac/8027/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahvaz Medical Sciences Research Vice-Chancellor - Dr. Mehrnoosh Zakirkish
Street address
Ahvaz, Golestan Boulevard, University City, Esfand St
City
AHVAZ
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Fax
+98 21 8882 4675
Email
sara.faramarzi.1996@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Shaiste Haghighi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Ahvaz, Golestan, Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery
City
AHVAZ
Province
Khouzestan
Postal code
1579 61357
Phone
+98 61 3311 0000
Fax
+98 61 3336 1544
Email
info@ajums.ac.ir
Web page address
https://ajums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Shaiste Haghighi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Ahvaz, Golestan, Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery
City
AHVAZ
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Fax
+98 61 3336 1544
Email
info@ajums.ac.ir
Web page address
https://ajums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sarah Faramazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Yek Salamat St., Koi Ramadan, Ahvaz
City
AHVAz
Province
Khouzestan
Postal code
6175997299
Phone
+98 21 3225 7027
Email
www.sara.faramarzi1996@gmail.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
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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