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Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients With in Patients Rheumatoid Arthritis

Primary Purpose

Therapeutics

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EMDR group
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Therapeutics focused on measuring Pain, EMDR, Patient, Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Under 18 years of age, Receiving another psychosocial therapy on working dates, Those who do not agree to participate in the research, Pregnancy, VAS pain score less than 4, Using analgesic medication at least 4 hours ago, Having a physical/mental disability or disability and illness that would prevent them from participating in EMDR, Exclusion Criteria: Who cannot complete the EMDR application for any reason (health problem, not being able to spare time) Patients who want to leave the study voluntarily will be excluded from the follow-up.

Sites / Locations

  • Mersin University HospitalRecruiting
  • Mersin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group (EMDR)

Control group

Arm Description

Since the aim of the study was to examine the effect of EMDR on pain, the pain levels of 32 the patients in the intervention group were examined before the first session and after the last session EMDR application. The control measurement was made 1 month after the last session of EMDR. To the initiative group; The first EMDR session was applied after the Personal Information Form and VAS were applied. The "Personal Information Form" was applied only once before the first session. Each EMDR session lasts between 45 and 90 minutes. EMDR was applied to the patients between 3-12 sessions. After the last EMDR session, "VAS" and "Individual In-depth Interview Question Form ". were applied.

Pre-test (VAS) and post-test (VAS), and 1 month later, control measurement (VAS) data collection forms were applied simultaneously with the admitted 32 the patients. No application was made to the patients except for routine follow-up, anamnesis and medical treatment.

Outcomes

Primary Outcome Measures

visual analog scale (vas)
When patients talk about the event they experienced about their pain, they no longer feel discomfort, they learn to cope with their pain without fear or anxiety. It will result in them expressing that it has become "just a living experience" or completion. The scale consists of a 10 cm ruler on which there is no pain on one end and excruciating pain on the other end, on which the patient marks the pain. 1 indicates at least 10 most pain.

Secondary Outcome Measures

Personal Information Form
This form, which was prepared by the researcher and developed by scanning the literature, consists of 14 questions. The personal information form consists of questions questioning sociodemographic characteristics (age, gender, marital status, etc.) and clinical characteristics (presence of chronic disease or pain, use of painkillers, etc.).

Full Information

First Posted
June 9, 2023
Last Updated
September 20, 2023
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT05944302
Brief Title
Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients With in Patients Rheumatoid Arthritis
Official Title
Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients With in Patients Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
They explained the improvement of pain in patients with EMDR treatment in chronic pain with Shapiro's adaptive information processing model. According to this model; The nociceptive sense is related to the emotional response. During the traumatic event, the painful stimulus is stored both physically and as an image, thought, and affect. Therefore, traumatic memories contain affective elements as well as conscious awareness and contribute significantly to stress along with chronic pain. Reprocessing these dysfunctionally stored memories will allow the problematic memories to integrate, resulting in both symptom relief and increased personal efficacy. According to the explanations made with the adaptive information processing model, the perception of the traumatic event is reprocessed with bidirectional stimulation given its somatic and affective components, and the cortical integration of the memory is provided. Changing the emotional dimension of pain may lead to changes in pain pathways, altering the memory and reproduction of pain in the nervous system. When desensitization is achieved against negative emotions; It has been hypothesized that once the patient has a more normal response to pain or stress, it will not revert to a limbic magnified response of pain unless a new trauma has been experienced. Painful conditions can continue to bother even after the illness or injury has been successfully treated. This may be the result of improperly stored memories and chronic active pain. In addition to medication, physical therapy, patient education and psychological support are very important in relieving rheumatological pain.
Detailed Description
In our study, it was considered to examine the effect of EMDR in reducing pain, one of the most common complaints of RA patients. Over time, the emotional discomfort caused by the pain increases with the persistence of the pain, and as a result, a medical condition causes a psychological problem to develop. Pain is a learned emotional experience. Therefore, psychological components should not be ignored in the evaluation of pain. At the end of EMDR sessions, patients are confident that they can effectively live with it, even if they have a very small amount of pain. He has learned to deal with pain without fear or anxiety. No more pain for the patient; It has become meaning "just an experience", realizing that living with pain is like traveling on a long road full of hidden pitfalls. EMDR applications have been used in many treatment applications in recent years. The reasons for this are the rapid results after the treatment and the simplicity of the procedure. EMDR has been accepted as an evidence-based treatment method by the UK Department of Health (2001), the American Psychiatric Association (2004), the Australian Post Traumatic Mental Health Center (2007) and the Dutch National Mental Health Guidelines Guidance Committee (2003). The increasing prevalence of EMDR treatment in psychiatric nursing practice is based on the increasing number of scientifically based reports. Studies have reported that EMDR application has positive effects on pain in different sample groups. In the literature review, it was seen that EMDR was applied to RA patients in only one study. In the study, 75 RA patients were divided into 2 intervention groups and a control group to compare the effect of EMDR and directed imagery on pain severity in RA patients. Between the two methods, it was concluded that EMDR was more effective on pain compared to the directed imagery and control group. It is assumed that EMDR can achieve beneficial results in RA patients. The aim of the nursing approach is to enable the patient to recognize their psychological state, try to reduce their negative emotions and use coping methods.The nurse has the responsibility of educating patients about treatments, providing patient counseling, and supporting the patient to make informed decisions and take responsibility for self-care. He also needs to research about treatment options and follow up on current treatments and interventions. Considering all these factors, it is thought that EMDR, which will be applied to RA patients by specialist psychiatric nurses trained in this subject, can be used as an independent nursing practice in reducing pain and improving vital signs. With this study the investigators planned, EMDR will be applied to RA patients, and it will be ensured that the data on whether this method is effective for pain will be brought to the literature. With the qualitative dimension, which is the second dimension of this study, which the investigators will bring to the literature, it will be ensured that the patients also express their feelings. In addition, this study will lead to the planning of new studies and publications, will reduce pain in patients with RA in whom EMDR is applied, will offer alternative options that specialist psychiatric nurses can apply in patients with pain, and will be a guiding resource for investigating the effect of EMDR on the pain of RA patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapeutics
Keywords
Pain, EMDR, Patient, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is two-stage. In the first stage, a randomized controlled trial type will be used to compare the effect of EMDR on pain in patients in the intervention and control groups, and in the second stage, a qualitative (qualitative) descriptive research type will be used to evaluate the experiences of the patients in the intervention group with the EMDR program.
Masking
None (Open Label)
Masking Description
In the study, block randomization will be done to eliminate selection bias and to provide balance in the number of individuals between groups. In this method, the number of groups and probabilities must be equal in each block. If we evaluate a study in which 2 different treatment methods (A and B) will be applied and the evaluations are equally probable; A total of 4 individuals are assigned to each block, with 2 subjects assigned to each treatment group. Thus, at the end of each quadruple assignment, the number of subjects in the 2 treatment groups is equalized.
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (EMDR)
Arm Type
Experimental
Arm Description
Since the aim of the study was to examine the effect of EMDR on pain, the pain levels of 32 the patients in the intervention group were examined before the first session and after the last session EMDR application. The control measurement was made 1 month after the last session of EMDR. To the initiative group; The first EMDR session was applied after the Personal Information Form and VAS were applied. The "Personal Information Form" was applied only once before the first session. Each EMDR session lasts between 45 and 90 minutes. EMDR was applied to the patients between 3-12 sessions. After the last EMDR session, "VAS" and "Individual In-depth Interview Question Form ". were applied.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Pre-test (VAS) and post-test (VAS), and 1 month later, control measurement (VAS) data collection forms were applied simultaneously with the admitted 32 the patients. No application was made to the patients except for routine follow-up, anamnesis and medical treatment.
Intervention Type
Behavioral
Intervention Name(s)
EMDR group
Intervention Description
Eye Movement Desensitization and Reprocessing
Primary Outcome Measure Information:
Title
visual analog scale (vas)
Description
When patients talk about the event they experienced about their pain, they no longer feel discomfort, they learn to cope with their pain without fear or anxiety. It will result in them expressing that it has become "just a living experience" or completion. The scale consists of a 10 cm ruler on which there is no pain on one end and excruciating pain on the other end, on which the patient marks the pain. 1 indicates at least 10 most pain.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Personal Information Form
Description
This form, which was prepared by the researcher and developed by scanning the literature, consists of 14 questions. The personal information form consists of questions questioning sociodemographic characteristics (age, gender, marital status, etc.) and clinical characteristics (presence of chronic disease or pain, use of painkillers, etc.).
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Individual In-depth Interview Question Form
Description
The Individual In-depth Interview Question Form created by the researcher in order to evaluate the experiences of RA patients with the EMDR program consists of 10 questions. The questionnaire was sent to five faculty members who are experts in the field of mental health and psychiatric nursing and expert opinion was obtained.There are no right or wrong answers to the questions. Questions do not have minimum and maximum values. These are qualitative questions to measure the experience of patients.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Under 18 years of age, Receiving another psychosocial therapy on working dates, Those who do not agree to participate in the research, Pregnancy, VAS pain score less than 4, Using analgesic medication at least 4 hours ago, Having a physical/mental disability or disability and illness that would prevent them from participating in EMDR, Exclusion Criteria: Who cannot complete the EMDR application for any reason (health problem, not being able to spare time) Patients who want to leave the study voluntarily will be excluded from the follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
müjde moran
Phone
+905055774978
Email
mujdemoran@mersin.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
serpil yılmaz
Phone
+905317967829
Email
serpil33@mersin.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
serpil yılmaz
Organizational Affiliation
Mersin University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mualla yılmaz
Organizational Affiliation
Mersin University
Official's Role
Study Director
Facility Information:
Facility Name
Mersin University Hospital
City
Mersin
State/Province
Yenişehir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
müjde moran, 1
Phone
+9005055774978
Email
mujdemoran@mersin.edu.tr
First Name & Middle Initial & Last Name & Degree
müjde moran, 1
First Name & Middle Initial & Last Name & Degree
mualla yılmaz, 3
First Name & Middle Initial & Last Name & Degree
serpil yılmaz, 2
Facility Name
Mersin University
City
Mersin
State/Province
Yenişehir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
serpil yılmaz
Phone
+905317967829
Email
serpil33@mersin.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients with in Patients Rheumatoid Arthritis
Links:
URL
https://dusunenadamdergisi.org/storage/upload/pdfs/1586350339-tr.pdf
Description
EMDR (With Eye Movements) Desensitization and Reconstruction Processing): Different in Psychotherapy One Option
URL
https://smartlib.umri.ac.id/assets/uploads/files/6cfb4-eye_movement_desensitization_and_reprocessing__emdr___basic_principles__protocols__and_procedures__2nd_edition.pdf
Description
Shapiro, F. (2001). Eye movement desensitization and reprocessing: Basic principles, proto
URL
https://arsiv.dusunenadamdergisi.org/tr/DergiPdf/DUSUNEN_ADAM_DERGISI_6eb40367c65a4a88af25e3aca7b8eac3.pdf
Description
Sinici, E. (2016). Evaluation of EMDR therapy efficacy in the treatment of phantom pain. The Journal of Psychiatry and Neurological Sciences, 29:349-358 DOI: 10.5350/DAJPN2016290406

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Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients With in Patients Rheumatoid Arthritis

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