- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05944302
EMDR on Pain in Patients With in Patients Rheumatoid Arthritis
Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients With in Patients Rheumatoid Arthritis
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: müjde moran
- Phone Number: +905055774978
- Email: mujdemoran@mersin.edu.tr
Study Contact Backup
- Name: serpil yılmaz
- Phone Number: +905317967829
- Email: serpil33@mersin.edu.tr
Study Locations
-
-
Yenişehir
-
Mersin, Yenişehir, Turkey
- Recruiting
- Mersin University Hospital
-
Contact:
- müjde moran, 1
- Phone Number: +9005055774978
- Email: mujdemoran@mersin.edu.tr
-
Principal Investigator:
- müjde moran, 1
-
Sub-Investigator:
- mualla yılmaz, 3
-
Sub-Investigator:
- serpil yılmaz, 2
-
Mersin, Yenişehir, Turkey
- Recruiting
- Mersin University
-
Contact:
- serpil yılmaz
- Phone Number: +905317967829
- Email: serpil33@mersin.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group (EMDR)
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. |
Eye Movement Desensitization and Reprocessing
|
No Intervention: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analog scale (vas)
Time Frame: 1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Personal Information Form
Time Frame: 1 year
|
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.).
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual In-depth Interview Question Form
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: serpil yılmaz, Mersin University
- Study Director: mualla yılmaz, Mersin University
Publications and helpful links
Helpful Links
- EMDR (With Eye Movements) Desensitization and Reconstruction Processing): Different in Psychotherapy One Option
- Shapiro, F. (2001). Eye movement desensitization and reprocessing: Basic principles, proto
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MesinU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Therapeutics
-
Minia UniversityCompleted
-
Universidade do Vale do ParaíbaCompleted
-
University of New MexicoCompleted
-
Medical University of LodzCompletedPeriodontitis | Therapeutics | Fatty Acids, UnsaturatedPoland
-
Lao-Oxford-Mahosot Hospital Wellcome Trust Research...Mahidol Oxford Tropical Medicine Research UnitNot yet recruitingInfectious Disease | TherapeuticsLao People's Democratic Republic
-
Mayo ClinicCompletedTelemedicine | Primary Health Care | Diagnosis | Therapeutics | Developing CountriesHonduras
-
Fundação de Medicina Tropical Dr. Heitor Vieira...Oswaldo Cruz Foundation; Ministry of Health, BrazilCompletedMalaria, Vivax | TherapeuticsBrazil
-
Tianjin Anding HospitalCompletedSchizophrenia | Therapeutics
-
Peking Union Medical CollegeUnknownBreast Neoplasm Female | Mutation | TherapeuticsChina
-
Lille Catholic UniversityAllerganUnknownJoint Diseases | Magnetic Resonance Imaging | Knee | TherapeuticsFrance
Clinical Trials on EMDR group
-
University of PisaCompletedCognitive Change | Child, Only | Distress, Emotional | Narration | Memory DysfunctionItaly
-
Centre Hospitalier René DubosTerminated
-
Dominique JANUELRecruiting
-
Academy of Therapeutic Sciences, TurkeyCompletedPost Traumatic Stress DisorderTurkey
-
Erasmus Medical CenterNot yet recruitingAnxiety and Fear
-
Medisch Spectrum TwenteLeiden University Medical Center; University of TwenteNot yet recruiting
-
University of PisaCompletedObsessive-Compulsive Disorder | Post-traumatic Stress Disorder | Guilt | Adult ALL | Shame | DisgustItaly
-
University Hospital, ToursInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedDepression | Burnout, Professional | Post Traumatic Stress DisorderFrance
-
Ciclo de MutaçãoSao Jose do Rio Preto Medical SchoolCompleted