Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
2020년 11월 2일 업데이트: Sarah R. Martin, University of California, Los Angeles
The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.
연구 개요
연구 유형
중재적
등록 (실제)
25
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Los Angeles, California, 미국, 90095
- University of California, Los Angeles
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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
12년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- A diagnosis of sickle cell disease
- Age 12-21 years old
- Fluent in English (the intervention will be delivered in English)
- Participant is cognitively able to provide informed signed consent or assent
- Participant is cognitively able to follow instructions
Exclusion Criteria:
- Under 12 years of age or over 21 years of age
- Not fluent in English
- Pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation.
- Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Attention Control
Participants will listen to a 30-minute historical story.
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A 30-minute historical story read by a research clinician.
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실험적: Hypnosis
Participants will receive a 30-minute hypnosis session
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A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in peripheral blood flow before and during the intervention
기간: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
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Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
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Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in pain threshold temperature
기간: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
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Pain threshold temperature will be determined by when participants report they first feel pain and change in pain threshold temperature will be assessed by comparing pain threshold temperature during the pre-intervention period (12 minutes before the start of the intervention) from pain threshold temperature during the intervention period (15 minutes after the start of the intervention).
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12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
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Change in pain tolerance temperature
기간: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Pain tolerance temperature will be determined by when participants report they can no longer tolerate the pain and change in pain tolerance temperature will be assessed by comparing pain tolerance temperature during the pre-intervention period (9 minutes before the start of the intervention) from pain tolerance temperature during the intervention period (18 minutes after the start of the intervention).
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9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Change in heat pulse pain intensity ratings
기간: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Heat pulse pain intensity ratings will be determined by participants' self-report of heat pulse pain intensity (rated on a 0-10 scale, with 0 being no pain and 10 being worst pain), and change in heat pulse pain intensity will be assessed by comparing pain tolerance temperature during the pre-intervention period (5 minutes before the start of the intervention) from heat pulse pain intensity during the intervention period (21 minutes after the start of the intervention).
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5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma
기간: 15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
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Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
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15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
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Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
기간: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention
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Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain threshold collected 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
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12 minutes before the start of the intervention and 15 minutes after the start of the intervention
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Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
기간: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain tolerance collected 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
기간: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain intensity collected 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in the effect of the intervention on Skin Conductance Response (SCR)
기간: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Skin Conductance Response (SCR) will be measured using continuous readings of electrical properties of the skin on the index finger and change in SCR will be assessed by comparing levels of SCR during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from SCR during the intervention period (15-21 minutes after the start of the intervention).
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12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Change in the effect of the intervention on Heart Rate Variability
기간: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Heart Rate Variability (HRV) will be measured using continuous readings of heartbeat intervals and change in HRV will be assessed by comparing HRV during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from HRV during the intervention period (15-21 minutes after the start of the intervention).
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12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Lonnie K Zeltzer, MD, UCLA Pediatric Pain and Palliative Care Program
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)
2018년 3월 16일
기본 완료 (실제)
2020년 6월 30일
연구 완료 (실제)
2020년 11월 1일
연구 등록 날짜
최초 제출
2016년 12월 1일
QC 기준을 충족하는 최초 제출
2016년 12월 6일
처음 게시됨 (추정)
2016년 12월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 11월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 11월 2일
마지막으로 확인됨
2020년 11월 1일
추가 정보
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. .