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Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery

2020년 3월 12일 업데이트: University of Haifa

Treating pain, just as treating other medical conditions, depends on accurate assessment of patient's condition. When assessing pain, as other subjective symptoms, the challenge is twofold because the assessment is dependent on patient's understanding and use of the scale, all the more so in children

So far, attempts to improve pain assessments have been focused on the development and refining pain scales. No emphasis has been placed on improving patient's ability to report their pain. Our purpose is to evaluate a training program designed to improve the quality of children's post-surgical pain intensity reports.

After receiving Helsinki approval, eligible children and their parents will signed informed-consent. After surgery, the children, their parents, and the department nurses will assess children's pain intensity. Immediately after the nurse assessment, parents will assess their child's pain (blindly and independently) and the children will report their pain on four different pain scales.

Children aged 8-17, hospitalized in Rambam medical-center for elective surgery will be invited to participate. Children in the experimental group will be exposed to a training program, developed for this study, aimed to teach and train how to report pain. The control group will receive the standard pre-surgical instructions.

연구 개요

상태

완전한

정황

연구 유형

중재적

등록 (실제)

98

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Haifa, 이스라엘, 3498838
        • University of Haifa, The Clinical Pain Innovation Lab

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

8년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. children at age 8-17 years;
  2. absence of psychiatry, cognitive, and/or neurological disorders;
  3. understand the purpose and the instructions of the study, agree to participate and parent signed inform consent.

Exclusion Criteria:

1. children suffering from Post traumatic stress disorder.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Interventional arm
The intervention, which was aimed to educate children on how to use pain scales and provide reliable pain assessments was based on a two short animation clips, lasting approximately 5 min each, and a short (5 min) guided interaction between the study nurse and the participants, in between the two clips.
The first animation clip focuses on the importance of pain assessment introduce three pain scales (categorical, NPS and faces) followed by explanations on their properties and on the appropriate way to use them.The second movie was aimed to provide an opportunity to implement the new knowledge in case studies
다른: Control
Children underwent the routine pre-operative preparations, which included a section on pain assessment.
Routine preoperative preparations, which included a section on pain assessment instructions.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Quality of pain intensity scores based on the concordance between pain reports on different scales.
기간: Pain intensity rating before analgesic consumption.
The average difference between scores reported on the different scales was calculated as follows: The difference between to pain scores reported on each possible pairs of two scales was calculated in absolute values. The average difference of the 6 pairs was calculated. The 5-point CAT was transformed into a 0-10 scale by multiplying its values by 2.5.
Pain intensity rating before analgesic consumption.
Quality of pain intensity scores based on the concordance between pain reports on different scales.
기간: Pain intensity rating one hour after analgesic consumption.
The average difference between scores reported on the different scales was calculated as follows: The difference between to pain scores reported on each possible pairs of two scales was calculated in absolute values. The average difference of the 6 pairs was calculated. The 5-point CAT was transformed into a 0-10 scale by multiplying its values by 2.5.
Pain intensity rating one hour after analgesic consumption.

2차 결과 측정

결과 측정
측정값 설명
기간
The difference between children assessment vs. nurses assessment.
기간: NPS ratings before and one hour after analgesic consumption
The difference between children pain assessment vs. nurses assessment on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
NPS ratings before and one hour after analgesic consumption
The average difference between children assessment vs. parents.
기간: NPS ratings before and one hour after analgesic consumption
The difference between children pain assessment vs. parents assessment on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
NPS ratings before and one hour after analgesic consumption
The average decrease in pain following analgesia: NPS
기간: NPS ratings before and one hour after analgesic consumption
The average decrease in pain following analgesic consumption (Delta NPS) based on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
NPS ratings before and one hour after analgesic consumption
Quality of pain intensity scores based on the concordance between pain reports on different scales.
기간: Pain intensity ratings before analgesic consumption.
The within-subjects standard deviation (SD) between the 4 pain scores (provided at the same time of assessment). To assure that variability will be appropriately reflected by this measure, subjects who reported only "0" or only "10" in all 4 scales were excluded from this analysis due to potential bias of the within-subjects SD due to floor or ceiling effects.
Pain intensity ratings before analgesic consumption.
Quality of pain intensity scores based on the concordance between pain reports on different scales.
기간: Pain intensity ratings one hour after analgesic consumption.
The within-subjects standard deviation (SD) between the 4 pain scores (provided at the same time of assessment). To assure that variability will be appropriately reflected by this measure, subjects who reported only "0" or only "10" in all 4 scales were excluded from this analysis due to potential bias of the within-subjects SD due to floor or ceiling effects.
Pain intensity ratings one hour after analgesic consumption.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 6월 20일

기본 완료 (실제)

2019년 11월 20일

연구 완료 (실제)

2019년 11월 21일

연구 등록 날짜

최초 제출

2020년 3월 8일

QC 기준을 충족하는 최초 제출

2020년 3월 12일

처음 게시됨 (실제)

2020년 3월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 3월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 3월 12일

마지막으로 확인됨

2020년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 0091-19-RMB

개별 참가자 데이터(IPD) 계획

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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