- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Maciej Lachowicz, PhD
- Telefonnummer: +48 605 072 627
- E-Mail: maciej.lachowicz@awf.wroc.pl
Studienorte
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Wroclaw, Polen
- Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wrocławiu
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Kontakt:
- Maciej Lachowicz, PhD
- Telefonnummer: +48 605 072 627
- E-Mail: maciej.lachowicz@awf.wroc.pl
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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. |
|
Experimental: 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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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Weighted Accuracy on TLoadDback (WAcc)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Perceived Workload (NASA-TLX)
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Letter Accuracy on TLoadDback
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Maciej Lachowicz, PhD, Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wrocławiu
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- COG-MASS-2026-01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
No individual participant data sharing plan has been established. Study results will be reported in aggregate.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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