NCT05944302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

June 9, 2023

Last Update Submit

July 18, 2024

Conditions

Keywords

PainEMDRPatientRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Personal Information Form

    1 year

Other Outcomes (1)

  • Individual In-depth Interview Question Form

    1 year

Study Arms (2)

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.

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.

Interventions

EMDR groupBEHAVIORAL

Eye Movement Desensitization and Reprocessing

Intervention group (EMDR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mersin University Hospital

Mersin, Yenişehir, Turkey (Türkiye)

Location

Mersin University

Mersin, Yenişehir, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

PainArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • serpil yılmaz

    Mersin University

    STUDY DIRECTOR
  • mualla yılmaz

    Mersin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head nurse

Study Record Dates

First Submitted

June 9, 2023

First Posted

July 13, 2023

Study Start

July 13, 2023

Primary Completion

July 2, 2024

Study Completion

July 18, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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

Locations