- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00760227
Testing the Effectiveness of Child and Parent-Targeted Health Promotion Interventions in Pediatric Stem Cell Transplantation
연구 개요
상세 설명
Treatment Plan: Interventions involve 3 components, Massage Therapy, Humor Therapy, and Relaxation Therapy, as described below:
Massage Therapy Patient and parents will meet with a licensed massage therapist at the time of admission. During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session. Each session will last approximately 1/2 hour. Massage sessions will be scheduled 3x/week from admission through week +3.
Humor Therapy For this component will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games.
Relaxation Therapy In the initial session held near the time of admission, parents will meet with the RA therapist, who will describe relaxation response and the benefits of a regular practice of relaxation techniques. They will be led through a modified progressive muscle relaxation induction, using breath awareness and muscle release, followed by guided imagery.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ohio
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Columbus, Ohio, 미국
- Columbus Children's Research Institute
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
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Tennessee
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Memphis, Tennessee, 미국, 38105
- St. Jude Children's Research Hospital
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Ontario
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Toronto, Ontario, 캐나다, M5G
- The Hospital for Sick Children
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
For Child Participants:
- Age 6-18 years inclusive.
- Scheduled to undergo allogeneic or autologous stem cell transplant.
- Anticipated hospital stay of at least 3 weeks.
- English speaking
For Resident Parent Participants:
- Parent speaks and reads English.
- Parent will be a primary caregiver for child during BMT.
- Parent will be available for the duration of transplant hospitalization.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 1: HPI-C
Child Intervention Only Group
|
Patient and parents will meet with a licensed massage therapist at the time of admission.
During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session.
Each session will last approximately 1/2 hour.
Massage sessions will be scheduled 3x/week from admission through week +3.
For this component will will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games.
|
|
다른: 2: HPI-CP
Parent and Child Intervention Group
|
Patient and parents will meet with a licensed massage therapist at the time of admission.
During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session.
Each session will last approximately 1/2 hour.
Massage sessions will be scheduled 3x/week from admission through week +3.
In the initial session held near the time of admission, parents will meet with the RA therapist, who will describe relaxation response and the benefits of a regular practice of relaxation techniques.
They will be led through a modified progressive muscle relaxation induction, using breath awareness and muscle release, followed by guided imagery.
|
|
간섭 없음: 3: SC
Standard Care Control Group- No Intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
To test the effectiveness of the health-promotion interventions in improving patient and parent well-being during the acute phase of BMT.
기간: 6 weeks
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6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sean Phipps, PhD, St. Jude Children's Research Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HOBIT3
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