- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07568301
Nature in Harmony: Music and Nature-based Self-care for Individuals With Acquired Brain Injuries and Their Care Partners
The goal of this pilot study is to determine the initial impact on wellbeing for clients with acquired brain injury and their care partner after engaging in a nature & music-based program facilitated by occupational therapy and music therapy. The main questions it aims to answer are:
- Primary Question: What is the impact on wellbeing for clients with acquired brain injury and their care partner after engaging in a nature & music-based program facilitated by occupational therapy and music therapy?
Secondary Question: What is the feasibility of a four-session nature & music-based wellness program for clients with acquired brain injury and care partner dyads?
- Attendance
- Satisfaction
- Accessibility
- Carryover of Strategies
Participants will complete self-reported surveys before and after completing 4 sessions of a nature & music-based program facilitated by occupational therapy and music therapy.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15228
- Duquesne University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- All participants must be above the age of 18 to participate.
- Able to communicate in English
- A person with an ABI can include persons with a diagnosis of traumatic brain injury, stroke, aneurysm, brain infection, and/or brain cancer.
- A care partner is broadly defined as a social support person who has been identified as a family member or friend of the person with the acquired brain injury.
- Capacity for consent - Person must be their own medical power of attorney
- Capacity for Self-Reflection (have a score of 23/35 on the MOCA or have a 5/6 on the Design Memory Test sub test of Cognition and Language Quick Test)
Exclusion Criteria:
- Self-reported severe-to profound hearing loss with the use of hearing aid(s)
- Cannot communicate in English
- Have a diagnosis of a progressive neurological disorder, such as Amyotrophic lateral sclerosis, Parkinson's disease, Dementia, Multiple Sclerosis
- Have a severe aphasia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Nature In Harmony
The Nature in Harmony program involves four in-person sessions held at Duquesne University's campus using the outdoor pavilion and community garden with the final session occurring at Frick Park at their Environmental Center located in Pittsburgh, PA, between May and June of 2026.
Each session will have a minimum of two principal investigators to lead the activities.
Graduate assistants will be at each session to provide additional hands-on support for safety, mobility, and participant engagement.
Participants will be instructed to complete carryover activities between sessions: one to be completed together dyadically (person with ABI & care partner) and one to be completed individually.
Dyads will reflect on the experience in their activity journal and share and the beginning of sessions 2-4.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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EUROHIS-QOL 8-item index
기간: First session to end of program approximately 4 weeks.
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EUROHIS-QOL 8 is a standardized assessment of general quality of life that assesses four domains of QOL: physical, psychological, social, and environmental.
This assessment has been validated for persons with traumatic brain injury (Balalla et al., 2019).
This is 5-point scale from "not at all" to "completely."
A high total point value indicates a better quality of life rating.
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First session to end of program approximately 4 weeks.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Connor-Davidson Resilience Scale
기간: First session to end of program approximately 4 weeks.
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The 10-item Connor-Davidson Resilience Scale will be administered as a secondary outcome to determine if any impacts are seen after this brief program because of participation.
This measure has been used with persons post-traumatic brain injury, stroke, and caregivers.
Rating scale goes from 0-4 with higher total scores indicating better resilence.
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First session to end of program approximately 4 weeks.
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Dyadic Relationship Scale
기간: First day to end of program approximately 4 weeks
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The 10-item Dyadic Relationship Scale will be administered as a secondary outcome to examine any changes in both positive and negative interactions between individuals with ABI and their care partners after this program (Sebern & Whitlatch, 2007).
This is a four point scale with a higher score indicating more negative dyad experiences.
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First day to end of program approximately 4 weeks
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Client Satisfaction Questionnaire (CSQ-8)
기간: Last session, approximately 4 weeks after first session
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This measure uses eight questions on a four point Likert-scale strongly agree to strongly disagree to assess participants' overall satisfaction with the program with a maximum score of 32 (Attkisson & Greenfield, 2004).
The average score for the group on the CSQ-8 is at least 24.
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Last session, approximately 4 weeks after first session
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Attendance
기간: Every week for 4 weeks.
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Session attendance will be tracked at every session throughout the program as either present "1" or absent "0".
Participants who attend all sessions will have a total of 4.
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Every week for 4 weeks.
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Accessibility of the strategies
기간: Every week of the program for four weeks.
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4-point Likert scale survey will be used to document participants' interest in using the covered strategies in the sessions.
Items will not be totaled and scales vary by question.
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Every week of the program for four weeks.
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Carryover of the strategies
기간: Weekly journal entries for weeks 2,3, and 4.
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A self-reported journal includes date, the name of the activity, length, and personnels will be provided for documenting the carryover activities outside of the session time.
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Weekly journal entries for weeks 2,3, and 4.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025/11/22
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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