- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05190367
Influence of Trauma on Pain Area and Widespreadness in Chronic Pain Patients
It is well known that patients suffering from chronic pain report higher levels of pain, anxiety, and depression if they have experienced a traumatic event. However, little is know about pain area and widespreadness.
In this retrospective study, we want to investigate whether pain area and widespreadness differs in chronic pain patients with and without traumatic events. To test this hypothesis we will retrospectively analyse pain drawings collected at the pain outpatient department from Hannover Medical School. Participants will be divided into four groups depending on the severity of their traumatic events: no trauma; accidental trauma; interpersonal trauma; post-traumatic stress disorder (PTSD).
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Hannover, 독일, 30625
- Hannover Medical School
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Chronic pain
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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No trauma
Patients suffering from chronic pain without traumatic life events
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Accidental trauma
Patients suffering from chronic pain who have experienced at least one accidental trauma
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Interpersonal trauma
Patients suffering from chronic pain who have experienced at least one interpersonal trauma
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PTSD
Patients suffering from chronic pain and diagnosed with PTSD
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Difference in pain area
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Pain area derived from electronic pain drawings (SymptomMapper).
The score ranges from 0 to 100% body area.
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in pain widespreadness
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Widespread pain index (WPI) derived from electronic pain drawings (SymptomMapper).
The score ranges from 0 (no pain) to 19 (pain affects all possible regions).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Difference in current pain
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in mean pain in the last four weeks
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in maximal pain in the last four weeks
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in acceptable pain
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in sleep impairment
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Visual analogue scale from 0 ("no impairment") to 100 ("maximal imaginable impairment").
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in pain-related disability
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Pain-related disability assessed via the Pain Disability Index (PDI).
The score ranges from 0 (no pain-related disability) to 70 (maximal disability).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in depression
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Depression assessed via the 9-item depression scale (PHQ-9) from the German version of the Patient Health Questionnaire (PHQ-D).
The score ranges from 0 (no depression) to 27 (maximal depression).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in somatic symptoms
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Somatic symptoms assessed via the 15-item somatic scale (PHQ-15) from the German version of the Patient Health Questionnaire (PHQ-D).
The score ranges from 0 (no somatic symptom burden) to 30 (maximal somatic symptom burden).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in anxiety
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Anxiety assessed via the 7-item anxiety scale (GAD-7) from the German version of the Patient Health Questionnaire (PHQ-D).
The score ranges from 0 (no anxiety) to 21 (maximal anxiety).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in stress
기간: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Stress assessed via the 10-item stress scale (PHQ-Stress) from the German version of the Patient Health Questionnaire (PHQ-D).
The score ranges from 0 (no stress) to 20 (maximal stress).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jorge Manuel Sánchez, Hannover Medical School
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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