- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07893886
Back Massage Before a Cognitive Task in Healthy Young Adults
Classical Massage as Preparation for a Cognitive Task: A Randomized Three-Condition Crossover Study
This study will compare a 15-minute back massage, 15 minutes of quiet rest, and no additional break before a mental task in healthy adults aged 18 to 27 years. Each participant will complete all three conditions in a random order at separate visits. The study will measure task accuracy, heart rate, skin conductance, and perceived workload to assess whether massage offers a benefit beyond rest.
연구 개요
상세 설명
This randomized crossover study includes three visits approximately two weeks apart. Task practice and individual calibration take place before a seated resting measurement. Participants then receive massage, rest lying face down, or proceed directly to the task. The TLoadDback task lasts 16 minutes at a fixed, individually calibrated pace. Physiological signals are recorded during rest and task performance. Participants complete the NASA-TLX questionnaire after the task.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Maciej Lachowicz, PhD
- 전화번호: +48 605 072 627
- 이메일: maciej.lachowicz@awf.wroc.pl
연구 장소
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Wroclaw, 폴란드
- Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wrocławiu
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연락하다:
- Maciej Lachowicz, PhD
- 전화번호: +48 605 072 627
- 이메일: maciej.lachowicz@awf.wroc.pl
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 to 27 years and good general health.
- Informed consent and ability to attend three visits.
- Normal or corrected vision, understanding of Polish instructions, and ability to perform the computer task with the dominant hand.
Exclusion Criteria:
- Neurological, psychiatric, or other conditions that may affect study participation or task performance.
- Medications or substances affecting autonomic function.
- Contraindications to massage, including relevant skin lesions or inflammation.
- Failure to understand the task after repeated instruction or to complete calibration.
- Cognitive or relaxation-focused nonpharmacological interventions within the previous three months, excluding recreational physical activity.
- Caffeine or nicotine within four hours, or strenuous exercise within 12 hours before a visit; the visit may be rescheduled.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Sequence ABC
Back massage, passive rest, then no additional break; one condition per visit before TLoadDback. |
A 15-minute classical back massage while lying face down, delivered by trained personnel before TLoadDback. A 15-minute quiet rest lying face down on the massage table without massage before TLoadDback. TLoadDback begins immediately after the seated resting baseline, without an additional 15-minute preparation period. |
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실험적: Sequence ACB
Back massage, no additional break, then passive rest; one condition per visit before TLoadDback. |
A 15-minute classical back massage while lying face down, delivered by trained personnel before TLoadDback. A 15-minute quiet rest lying face down on the massage table without massage before TLoadDback. TLoadDback begins immediately after the seated resting baseline, without an additional 15-minute preparation period. |
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실험적: Sequence BAC
Passive rest, back massage, then no additional break; one condition per visit before TLoadDback. |
A 15-minute classical back massage while lying face down, delivered by trained personnel before TLoadDback. A 15-minute quiet rest lying face down on the massage table without massage before TLoadDback. TLoadDback begins immediately after the seated resting baseline, without an additional 15-minute preparation period. |
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실험적: Sequence BCA
Passive rest, no additional break, then back massage; one condition per visit before TLoadDback. |
A 15-minute classical back massage while lying face down, delivered by trained personnel before TLoadDback. A 15-minute quiet rest lying face down on the massage table without massage before TLoadDback. TLoadDback begins immediately after the seated resting baseline, without an additional 15-minute preparation period. |
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실험적: Sequence CAB
No additional break, back massage, then passive rest; one condition per visit before TLoadDback. |
A 15-minute classical back massage while lying face down, delivered by trained personnel before TLoadDback. A 15-minute quiet rest lying face down on the massage table without massage before TLoadDback. TLoadDback begins immediately after the seated resting baseline, without an additional 15-minute preparation period. |
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실험적: Sequence CBA
No additional break, passive rest, then back massage; one condition per visit before TLoadDback. |
A 15-minute classical back massage while lying face down, delivered by trained personnel before TLoadDback. A 15-minute quiet rest lying face down on the massage table without massage before TLoadDback. TLoadDback begins immediately after the seated resting baseline, without an additional 15-minute preparation period. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weighted Accuracy on TLoadDback (WAcc)
기간: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Weighted accuracy across the full task: 0.65 x letter accuracy + 0.35 x digit accuracy. Letter accuracy includes correct detections and correct withholding of responses; digit accuracy is correct parity classification. Scores range from 0 to 100%, with higher scores indicating better performance. |
During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Mean Heart Rate During TLoadDback
기간: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Mean heart rate in beats per minute during the task, derived from photoplethysmography. Analyses will account for the precondition resting baseline from the same visit. |
During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Mean Skin Conductance During TLoadDback
기간: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Mean skin conductance in microsiemens during the task. Analyses will account for the precondition resting baseline from the same visit. |
During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceived Workload (NASA-TLX)
기간: Immediately after the task at each of three visits approximately two weeks apart (about four weeks in total).
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Unweighted mean of six NASA-TLX ratings, each scored from 0 to 100 and oriented so that higher values indicate greater workload or poorer perceived performance. |
Immediately after the task at each of three visits approximately two weeks apart (about four weeks in total).
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Median Response Time on TLoadDback
기간: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Median response time, in milliseconds, for correct responses that require a key press during the task. |
During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Letter Accuracy on TLoadDback
기간: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Percentage of correct letter trials, including correct detections of repeated letters and correct withholding of responses to nonrepeated letters. Higher values indicate better performance. |
During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Digit Accuracy on TLoadDback
기간: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Percentage of correctly classified digit-parity trials. Scores range from 0 to 100%, with higher values indicating better performance. |
During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Incorrect Responses on TLoadDback
기간: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Number of incorrect responses during the task. Higher counts indicate more errors. |
During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Omitted Required Responses on TLoadDback
기간: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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Number of trials with no response when a response is required. Correct withholding of a response to a nonrepeated letter is not counted as an omission. |
During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
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공동 작업자 및 조사자
수사관
- 수석 연구원: Maciej Lachowicz, PhD, Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wrocławiu
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
- COG-MASS-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
No individual participant data sharing plan has been established. Study results will be reported in aggregate.
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. .