TherapeuticsNCT05944302
EMDR on Pain in Patients With in Patients Rheumatoid Arthritis
A study testing EMDR group in people with Therapeutics, run by Mersin University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Therapeutics
- What is being tested?
- EMDR group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 Jul 2023to 18 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Mersin University Hospital
Mersin, Yenişehir
Mersin University
Mersin, Yenişehir
About this study
Official title: Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients With in Patients Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Therapeutics
- Being tested
- EMDR group
- Keywords
- Pain, EMDR, Patient, Rheumatoid Arthritis
- Medical subject headings
- Pain, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR groupBehavioural
Eye Movement Desensitization and Reprocessing
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (EMDR) | Experimental | 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. Receives: Behavioral: EMDR group |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start13 Jul 2023
- Primary completion2 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TherapeuticsStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, müjde moran, Mersin University
- Investigators
- serpil yılmaz, Study director, Mersin Universitymualla yılmaz, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944302
- Sponsor's protocol ID
- MesinU
- Status last verified
- Jul 2024
- First submitted
- 9 Jun 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients with in Patients Rheumatoid Arthritis
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients With in Patients Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05944302
- Acronym / sponsor ID
- MesinU
- Conditions
- Therapeutics
- Keywords
- Pain, EMDR, Patient, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (EMDR) | Experimental | Behavioral: EMDR groupSince 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR groupEye Movement Desensitization and Reprocessing | Behavioural | Intervention group (EMDR) |
Primary outcome
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 secondary outcome
Personal Information Form
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- EMDR (With Eye Movements) Desensitization and Reconstruction Processing): Different in Psychotherapy One OptionLink provided by the sponsor.
- Shapiro, F. (2001). Eye movement desensitization and reprocessing: Basic principles, protoLink provided by the sponsor.
- 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/DAJPN2016290406Link provided by the sponsor.
- Individual participant dataSharing planned: No. Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Pain in Patients with in Patients Rheumatoid Arthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
serpil yılmaz study director
Mersin University
mualla yılmaz study director
Mersin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR group in people with Therapeutics, run by Mersin University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (vas) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.