NCT07262177 Dance-Mindfulness Intervention for Well-Being in Recreational Adults
| NCT ID | NCT07262177 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Thessaly |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-09-02 |
| Primary Completion | 2026-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-09-02 with a primary completion date of 2026-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This 12-week study protocol outlines a randomized controlled trial designed to evaluate the effectiveness of a Dance-Mindfulness intervention integrating Modern Theatre Dance with mindfulness-based embodied practices to enhance psychological wellbeing, nervous system regulation, and embodied awareness in adults. The intervention combines: (1) polyvagal-informed breath-movement synchronization (nasal breathing, grounding); (2) ISTD (Imperial Society of Teachers of Dancing) Modern Theatre Dance technique progression and dance movements (Grades 2-4); (3) nervous system regulation through somatic practices; and (4) phenomenological reflection via weekly journaling and post-session integration. Study Design: Parallel-assignment randomized controlled trial (approx. N=320; n=160 intervention, n=160 waitlist control). Randomization uses computer-generated block randomization (block sizes 4-6). Outcomes: Perceived stress, mindfulness psychological wellbeing (happiness, life satisfaction), emotional regulation, social connection, movement confidence. Qualitative Component: Phenomenological interviews and weekly reflective journals from subsample (approx. n=20) analyzed via Interpretative Phenomenological Analysis and Reflexive Thematic Analysis. Intervention Delivery: 90-100 minute weekly sessions delivered over 12 weeks by qualified facilitator(s) trained in Modern Theatre Dance, mindfulness (≥3 years personal practice, MBSR, yoga or equivalent), trauma-informed care, and group facilitation. Sessions include 8 structured components: breath-grounding (9-10 min), technical dance work (14-15 min), conditioning (9-10 min), break-settling (4-5 min), rhythm improvisation (8-9 min), choreographed sequences (15-17 min), cool-down-integration (8-9 min), and phenomenological journaling (10-20 min). Safety \& Fidelity: Structured facilitator guidelines, session checklists, weekly supervision, adverse event protocols, and external fidelity monitoring ensure protocol integrity. Classroom size: 15-18 participants per session. Data Collection: Baseline (Week 0), mid-intervention (Week 6 only for qualitative), post-intervention (Week 12), and optional 1-3 month follow-up. Intent to treat analysis and mixed-effects modeling for between-group comparisons. Population: Adults (age 18+) seeking wellbeing enhancement through recreation or stress reduction. Eligible participants without acute mental health crisis. Primary Purpose: Health promotion and mental health improvement through nervous system regulation, embodied awareness, and psychosocial wellbeing enhancement.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years and older * Enrolled in dance classes (preferring modern/contemporary) at participating schools for at least 6 months prior to study enrollment * Able and willing to attend weekly sessions for 12 consecutive weeks (minimum 70% attendance required) * Able to understand and complete study questionnaires in Greek language * Able to engage in moderate-intensity movement and dance activities without acute medical contraindications * Written informed consent provided * Willing to be randomly assigned to intervention or waitlist control group Exclusion Criteria: * Musculoskeletal or neurological conditions limiting safe participation in moderate-intensity movement (e.g., acute injury, severe arthritis, neurological disease affecting coordination/balance) * Current severe psychological distress or mental health crisis requiring immediate clinical intervention (screened via DASS-21; cutoff: Severe or Extremely Severe on any subscale) * Pregnancy or planning pregnancy during the 12-week study period * Current concurrent participation in other psychological interventions, therapy, or mind-body programs (Pilates, yoga, tai-chi, other mindfulness-based interventions) * Unable to attend ≥70% of weekly sessions due to scheduling constraints or anticipated absences * Inability to provide informed consent or complete questionnaires in Greek * Acute medical illness or hospitalization within 2 weeks of study start * History of substance abuse disorder currently active or untreated
Contact & Investigator
Aglaia Zafeiroudi, SES
STUDY CHAIR
University of Thessaly
Frequently Asked Questions
Who can join the NCT07262177 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07262177 currently recruiting?
Yes, NCT07262177 is actively recruiting participants. Contact the research team at azafeiroudi@uth.gr for enrollment information.
Where is the NCT07262177 trial being conducted?
This trial is being conducted at Trikala, Greece.
Who is sponsoring the NCT07262177 clinical trial?
NCT07262177 is sponsored by University of Thessaly. The principal investigator is Aglaia Zafeiroudi, SES at University of Thessaly. The trial plans to enroll 160 participants.