Efficacy of eye Movements Desensitization and Reprocessing on the Psychological Well-being of the Patients with chronic renal failure under Hemodialysis
Determining the effect of eye movement desensitization and reprocessing on the psychological well-being of chronic renal failure patients undergoing hemodialysis.
Design
In this experimental clinical trial study, 90 patients with chronic renal failure undergoing hemodialysis were selected as simple and randomly divided into two intervention and control groups by block method.
Settings and conduct
In the current study, the research environment will be Hajieh Narges Mahshahr Hospital.
The method consists of 8 steps. The first step is to identify traumatic events with the cooperation of the patient, the second step is to explain the process and preparation, the third step is to identify positive thoughts from the patient, the fourth step is to desensitization, the fifth step is to create positive cognition, the sixth step is to process, the seventh step is to end the sessions and the eighth step is to re-evaluate. be
Participants/Inclusion and exclusion criteria
Inclusion criteria: giving informed consent - being between 15 and 60 years old having a history of hemodialysis treatment for more than three months
Exclusion criteria: having history of mental illness - visual impairment- having addictions
Intervention groups
Intervention group: For the intervention group, the researcher performed desensitization with eye movements and reprocessing three times a week for 4 weeks in a row in 30-45 minutes sessions after performing hemodialysis in a room previously coordinated with the hospital authorities. will, does.
Control group: For the control group, there will be no intervention except for routine medical care and support of these people by their families.
After the intervention, psychological well-being components were measured in both groups.
Main outcome variables
psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220529055015N1
Registration date:2023-01-24, 1401/11/04
Registration timing:prospective
Last update:2023-01-24, 1401/11/04
Update count:0
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
zahra ghasemirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4362 1653
Email address
saya.rad64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-30, 1401/11/10
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of eye Movements Desensitization and Reprocessing on the Psychological Well-being of the Patients with chronic renal failure under Hemodialysis
Public title
Efficacy of eye Movements Desensitization and Reprocessing on the Psychological Well-being
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
having consent informed to enter the study
Patients who undergo regular hemodialysis three times a week.
Has a history of hemodialysis treatment for more than three months
Age between 15 and 60 years
Exclusion criteria:
Having history of seizures
Having mental illnesses
Having addictions
Having vision problems
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were divided into two groups through a random block allocation process. In order to create the sequence and concealment, the online software with the following address will be used, and a special randomization code will be generated.
Sealed Envelope Ltd. 2021. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 18 Jun 2022
To perform this method, the number of intervention groups (two groups A and B), the size of each block (blocks of 6) and the number of sample size (90 samples) were entered in the mentioned site. Then the site presented a list with 15 blocks of 6. In this study, we use blocks of 6, and the website performs randomization and assigns numbers to the blocks.
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
Yasouj University of Medical Sciences
Street address
Shahid Motahari Blvd.- Yasouj University of Medical Sciences-Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.YUMS.REC.1400.204
Health conditions studied
1
Description of health condition studied
Psychological well-being
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Psychological well-being
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Psychological well-being questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The study will be done in both morning and evening shifts at Hajieh Narges Mahshahr Hospital. Then, for the intervention group, the researcher will perform EMDR treatment three times a week for 4 weeks in a row in 30-45 minutes sessions after hemodialysis in a room previously coordinated with the hospital authorities. After the intervention, psychological well-being components will be measured again in this group. The method of desensitization with eye movements and reprocessing consists of 8 steps: First step: the traumatic scene or scenes will be identified with the cooperation of the patient and the researcher. Then, with the cooperation of the patient, the most uncomfortable traumatic scene is selected. The second stage (explanation and preparation): creating a therapeutic alliance, explaining the process of desensitization with eye movements and reprocessing, explaining the effects of the desensitization method with eye movements and reprocessing, explaining treatment expectations and preparing clients. The third stage (examination): In this stage, the client is asked to visualize the scene or incident that creates the most positive and peaceful feeling in his mind. The fourth stage (desensitization of the target): focusing on the negative belief. The client moves the therapist's fingers quickly and simultaneously to the left and right in front of him, asking the client to follow the movements of the fingers with only eye movements. The fifth stage (creating positive cognition): cognitive reconstruction, strengthening the client's positive belief to replace the negative belief. The sixth stage (body processing): asking the helper to join and maintain the target event at the same time and recognizing the positive word and checking the muscle tension. The seventh stage (ending the sessions): asking the client to express the disturbing image, thoughts or emotions experienced. During the treatment, remember the events experienced in the treatment process in the form of thoughts, conditions, dreams, memories and other issues in the notebook. The eighth stage (re-evaluation): evaluation of previously processed goals (evaluation of the main variable). Visual tracking of the movement of the therapist's finger in the same state that the patient imagines the traumatic scene one after another - the patient must follow the rapid movements of the therapist's finger, which is across his field of vision, with rapid eye movements. The therapist's finger should be approximately 30 cm away from the subject's eyes and move from right to left and vice versa in the patient's field of vision. This movement consists of going back and forth twice in one second, which is considered one cycle, and every 12-24 cycles is one set. After each set, the therapist tells the patient to stop visualizing the scene and lean back in his chair and take a deep breath. This process is repeated several times according to the needs and motivation level of the patient.
Category
Behavior
2
Description
Control group: In the control group, there will be no intervention other than routine medical care and support of these people by their families. Routine interventions include nursing care before, during and after hemodialysis, which can also include nursing consultations. Continuing to use medications prescribed by doctors.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajiya Narges Hospital in Mahshahr
Full name of responsible person
Mohammad Behnammoghadam
Street address
in front of Haj Ebrahim School, Motahari street
City
Mahshahr
Province
Khouzestan
Postal code
7591994799
Phone
+98 61 5232 2082
Email
mbehnam1363@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Hossein marioryad
Street address
Shahid Motahari Blvd.- Yasouj University of Medical Sciences, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
mbehnam1363@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Motahari Blvd.- Yasouj University of Medical Sciences, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
mbehnam1363@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Motahari Blvd.- Yasouj University of Medical Sciences, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
mbehnam1363@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Motahari Blvd.- Yasouj University of Medical Sciences, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
mbehnam1363@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