The research environment is the hemodialysis center of Shiraz Imam Reza clinic. Informed and written consent is obtained from the participants. In the intervention, the participants are taught a series of positive and negative sentences to say three times and each time after saying a positive or negative sentence, hit certain points of the body seven times. Participants of both groups receive routine medical care. The participants, the data collector and the data analyst are blinded to the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 18 years and older, At least 6 months have passed since the start of hemodialysis, Perform hemodialysis 2 to 4 times a week, Ability to understand and speak Farsi language.
Exclusion criteria: The existence of a known chronic mental illness (confirmed by the attending physician), A patient with retinopathy.
Intervention groups
After allocating the participants in the intervention and control groups, they will complete the questionnaires. During a short interview with the intervention group, unpleasant factors that caused them discomfort are identified.Then, the intervention group is encouraged to focus on these unpleasant factors and perform Emotional Freedom Techniques. This technique will be performed by the participants for 4 weeks and 3 days per week (once a day).
Main outcome variables
Fatigue؛ Anxiety؛ Symptom Burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191021045178N5
Registration date:2024-02-29, 1402/12/10
Registration timing:registered_while_recruiting
Last update:2024-02-29, 1402/12/10
Update count:0
Registration date
2024-02-29, 1402/12/10
Registrant information
Name
Nilofar Pasyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 6293
Email address
pasyarn@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-24, 1402/12/05
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of effect of the Emotional Freedom Technique on fatigue, anxiety and symptoms burden of patients under hemodialysis
Public title
The effect of the Emotional Freedom Techniques on fatigue, anxiety and symptoms burden of patients under hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with an 18 - year - old and more
at least 6 months since the dialysis started
Doing hemodialysis 2 to 4 times at week.
The ability to understand and speak persian
Exclusion criteria:
The presence of chronic mental illness known by a physician's diagnosis
A patient suffering from retinopathy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in this study، The participants are unaware of the characteristics of the study groups. Data collection and completion of questions will be conducted by the first research assistant who does not know about the division of groups. It is also the statistician who does data analysis as blind to groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Moral Committee of shiraz Medical science university
Street address
Vice Chancellor for Research, 7th floor, Shiraz University of Medical Science, Zand st.
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.132
Health conditions studied
1
Description of health condition studied
Kidney dialysis
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Anxiety scores in Spielberger's state-trait anxiety questionnaire
Timepoint
Before the intervention and four weeks after an intervention (Emotional Freedom Techniques)
Method of measurement
Spielberger state- trait anxiety inventory
2
Description
Fatigue scores on the Multidimensional Fatigue Inventory
Timepoint
Before the intervention and four weeks after an intervention (Emotional Freedom Techniques)
Method of measurement
Multidimensional Fatigue Inventory
3
Description
Physical and mental symptom burden score in dialysis Symptoms burden Index questionnaire
Timepoint
Before the intervention and four weeks after an intervention (Emotional Freedom Techniques)
Method of measurement
Dialysis Symptoms burden Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After Informed consent and completing the questions by the intervention group، in a short interview with the patient, it is clear that the situation has caused unhappiness، Then with an unpleasant concentration, a series of positive and negative words are introduced to the patient in order to comfort themselves by those words. In our first phase in the intervention group, we want patients to say the positive and negative tree times like, (I'm always nervous about being dependent on the dialysis device, but I accept myself as I am) and every time they says that، with the top of the middle finger hit to the karate chop point in the other hand Gently 7 times ، so that the dominant hand might bend over the wrist. At the next stage they said negative words (I'm always nervous about being dependent on the dialysis device) and hit to the meridian points Including: the top of head, the beginning of the eyebrows, side of the eyes, under the eyes، the distance between the nose and upper lip, the chin, under the clavicle and armpit 7 times. next they said positive words (I accept myself as I am) and again they hit every point 7 times. This technique goes on for 4 weeks and every week for three days. The people in the control group only receive normal medical care.
Category
Behavior
2
Description
Control group: After informed consent and completing the questionnaires, participants in the control group will receive only routine medical care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Day and Night Clinic
Full name of responsible person
fatemeh parvizi
Street address
Rehmat Blvd., Serah Darul Rahma, Imam Reza Day and Night Clinic
City
shiraz
Province
Fars
Postal code
7165944639
Phone
+98 71 3735 5853
Email
npasyar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mohammad hashem hashempur
Street address
خیابان زند، ساختمان مرکزی دانشگاه علوم پزشکی شیراز، طبقه هفتم، معاونت تحقیقات و فناوری
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
29224
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
Nilofar pasyar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing Education
Street address
Shiraz, Namazi Square, the entrance to Namazi Hospital, Hazrat Fatemeh College of Nursing and Midwifery.
City
shiraz
Province
Fars
Postal code
13119-71936
Phone
+98 71 3647 4254
Email
npasyar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nilofar pasyar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing Education
Street address
Shiraz, Namazi Square, the entrance to Namazi Hospital, Hazrat Fatemeh College of Nursing and Midwifery.
City
shiraz
Province
Fars
Postal code
13119-71936
Phone
+98 71 3647 4254
Email
Npasyar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nilofar pasyar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing Education
Street address
Shiraz, Namazi Square, the entrance to Namazi Hospital, Hazrat Fatemeh College of Nursing and Midwifery.
City
shiraz
Province
Fars
Postal code
13119-71936
Phone
+98 71 3647 4254
Email
Npasyar@sums.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