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The effect of Emotional Freedom Technique (EFT) on fatigue and pain in women with multiple sclerosis

Protocol summary

Study aim
Determining the effect of emotional freedom technique on the severity of fatigue and pain in women with multiple sclerosis
Design
This study is clinical trial ,a single-blind,two parallel groups, and three-stage, pre-test, Immediately and 4-week after the interventional . In this study, considering the probability of a 10% drop ,60 women with multiple sclerosis with the inclusion criteria for referral to MS clinic of Ayatollah Kashani Hospital in Isfahan is selected by simple method and is divided equally into two groups of test and sham by minimiaztion method.
Settings and conduct
In this study, 60 women with MS who referred to the MS Clinic of Ayatollah Kashani Hospital in Isfahan are randomly divided into two groups of 30 subjects in test and placebo (sham). The research subjects are completely unaware of their group and the study is a single-blind.For the test group, the emotional freedom technique (EFT) based on the method provided by Gary Craig, discoverer of this technique, for 4 weeks, and 2 times per week a total of 8 sessions), and each session is performed for half an hour. In the sham group, the EFT psychological part was shared and on false points with a milder tapping at the same time will be done.
Participants/Inclusion and exclusion criteria
Inclusion Criteria.1)Women with MS, 18 to 50 years old.2) Having a fatigue index equal to or greater than 4 based on the scale. Fatigue severity scale. 3)having a pain score at least 4 for at least 6 months.4) A score EDSS equal to or less than 4.5 .5) No other illness other than MS .6)Absence in the menstrual period. 7) Not Pregnancy.8) Non-use of other alternative and complementary methods in the last 6 months.9) Non-drug addiction and psychosis. 10)No harm and wound in the desired acupuncture points. Exclusion Criteria :1)Unwillingness to continue to collaborate in research. 2)Use of other complementary therapies such as acupuncture, yoga, meditation during intervention, 3)absences for more than two consecutive sessions during the study.4) In case of pregnancy, recurrence of illness or hospitalization in hospital during intervention.5)Added new analgesic drug to previous medications
Intervention groups
The intervention groups consisted of two experimental and control groups (sham). In the experimental group, the emotional freedom technique(EFT) will be performed for a period of 4 weeks, two 30-minute session in per week, and in the sham group, with repetition of set up and exposure sentences, such as the experimental group, instead of tapping on the main points EFT, the lighter taps on false points will be performed and all other conditions and duration of intervention in both groups are the same.
Main outcome variables
Severity of fatigue, Severity of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140422017387N6
Registration date: 2018-01-24, 1396/11/04
Registration timing: retrospective

Last update: 2018-01-24, 1396/11/04
Update count: 0
Registration date
2018-01-24, 1396/11/04
Registrant information
Name
Fatemeh Nazari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7589
Email address
nazari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
empty
Scientific title
The effect of Emotional Freedom Technique (EFT) on fatigue and pain in women with multiple sclerosis
Public title
The effect of Emotional Freedom Technique on fatigue and pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria:Women with multiple sclerosis 18 to 50 years old at least 6 months of definite diagnosis of MS Having fatigue severity score equal to or greater than 4 based on Fatigue severity scale(FSS) Having a pain score at least 4 for at least 6 months based on the numerical rating scale of pain(NRS) A score equal to or less than 4.5 on the Expanded Disability Status Scale (EDSS) No other illness other than MS is approved by the physician and medical records of the subject Absence in the menstrual period. Not Pregnancy Non-use of other alternative and complementary methods in the last 6 months Non-drug addiction and psychosis. No harm and wound in the desired acupuncture points
Exclusion criteria:
Exclusion Criteria:unwillingness to continue to collaborate in research Use of other complementary therapies such as acupuncture, yoga, meditation during intervention Absences for more than two consecutive sessions during the study In case of pregnancy, recurrence of illness or hospitalization in hospital during intervention. Added new analgesic drug to previous medications
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the samples were selected by simple method among patients with MS who had the criteria for entering the study with informed written consent and then by Minimization method using Mini-py software, they were randomly divided into two groups of test and sham with 1: 1 ratio
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the participants will not aware of their intervention
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences.Hezar Jerib st.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-05-30, 1396/03/09
Ethics committee reference number
IR.MUI.REC.1396.3.017

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
The fatigue severity score based on Fatigue severity Scale (FSS)
Timepoint
Before, immediately and four week after interventions
Method of measurement
Questionnaire of the fatigue severity score for MS Patients(FSS)

Secondary outcomes

1

Description
Pain severity based on numerical ratting scale (NRS)
Timepoint
Before, immediately and four week after interventions
Method of measurement
based on 10 numerical ratting scale (NRS)

Intervention groups

1

Description
Intervention group: In the experimental group, the intervention of emotional freedom technique (EFT ),for each patient individually is performed for 4 weeks at twice a week for 30 minutes.This technique has four steps, the first step is called "The setup phrase",that patient repeats 3 times "Even though I have pain (the name of the problem), I deeply and completely accept myself",and Concurrent researcher massages the sore spot point (point ST14 acupuncture). In the second step, the patient focusing on the problem, researcher taps 10 times on 13 acupuncture points including points (DU20, BL2, GB1, ST1, GV26, CV24, KD27, SP21, LU11, LI1, HT9, SI3 PC9) with pointed and middle fingertips. In the third step, the researcher taps on gamut point at the back of the hand (TH3 acupuncture point) and at the same time 9 brain stimulator actions involving( closing, opening the eyes, looking Go down and right, looking down and left, turning the eyes clockwise, and then opposing it, whispering a favorite song for 2 seconds, fast counting numbers from 1 to 5, muttering the desired song to For 2 seconds ) by the patient is performed and the fourth step is the second step repetition, Performing these 4 steps is called an eft round and these cycles were repeated for 30 minutes.
Category
Treatment - Other

2

Description
In this study, the sham group (placebo) will be the control group.The researcher, while tapping with the point and middle fingers on the false points including biparital, the outer margin of the chin, the sides, the vertex of the nails, the forearm, wants the patient who repeat set up phrase and focussin the problem (like the test group), this procedure will also be performed for 30 minutes , 2 times in weeks within 4 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
MS clinic of Ayatollah Kashani Hospital Isfahan.
Full name of responsible person
Fateme Nazari
Street address
Ayatollah Kashani Hospital ,Kashani Ave.
City
Isfahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Email
nazari@nm.mui.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Movahedian Attar
Street address
Isfahan University of Medical Sciences, Hezar Jerib st,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Position
MSc Nursing, Faculty member, School of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib st,Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7589
Email
nazari@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Nazari
Position
Faculty Member of the school of Nursing, Adult Health Group
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Department of Nursing Adult Health, School of Nursing and Midwifery, University of Medical Science.Hezar jerib st. Isfahan.
City
Isfahan
Province
Isfehan
Postal code
81746-73465
Phone
+98 31 3792 7589
Fax
+98 31 1669 9398
Email
nazari@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Nazari
Position
Faculty Member of the school of Nursing, Adult Health Group
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Science, Hezar Jerib St, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7589
Fax
+98 31 1669 9398
Email
nazari@nm.mui.ac.ir

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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