- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Maciej Lachowicz, PhD
- Numéro de téléphone: +48 605 072 627
- E-mail: maciej.lachowicz@awf.wroc.pl
Lieux d'étude
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Wroclaw, Pologne
- Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wrocławiu
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Contact:
- Maciej Lachowicz, PhD
- Numéro de téléphone: +48 605 072 627
- E-mail: maciej.lachowicz@awf.wroc.pl
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Weighted Accuracy on TLoadDback (WAcc)
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perceived Workload (NASA-TLX)
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Letter Accuracy on TLoadDback
Délai: During the 16-minute task at each of three visits approximately two weeks apart (about four weeks in total).
|
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
Délai: 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
Délai: 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
Délai: 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).
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Maciej Lachowicz, PhD, Akademia Wychowania Fizycznego im. Polskich Olimpijczyków we Wrocławiu
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- COG-MASS-2026-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
No individual participant data sharing plan has been established. Study results will be reported in aggregate.
Informations sur les médicaments et les dispositifs, documents d'étude
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