Clinical trial NCT06788041: EFFECT of HAMMAM EXPERIENCE on GENERAL HEALTH and PERCEIVED WELL-BEING
Official title: ANALYSIS of the EFFECT of HAMMAM EXPERIENCE on GENERAL HEALTH and PERCEIVED WELL-BEING COMPARED to MASSAGE and PLACEBO : a RANDOMIZED CROSS-SECTIONAL STUDY.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Stress
Wellness
General Health
Keywords: hamman
balneotherapy
massage
chronic stress
general health
wellness
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: AL ÁNDALUS BAÑOS ÁRABES (Hammam Granada)
First posted: 2025-01-22
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this study is to analyze the effect of a Hammam experience, a massage experience and a placebo in a healthy general population on their general health and perception of well-being, assessed with biophysiological, physical and psychoemotional markers, and its impact on chronic stress. Our hypothesis is that the Hammam experience will produce a more favorable acute (just after the experience) and subacute (24 hours after the experience) response on the study variables than the other interventions with at least a moderate effect size.


Eligibility criteria: Inclusion Criteria:

* Men and women (50%) 25-65 years old
* No metabolic risk.
* Resident in the province of Granada.
* Socio-economic level: medium-high
* Experience in self-care
* Spanish level C2

Exclusion Criteria:

* Pregnancy
* Participation in treatments and relaxation techniques or taking medication (anxiolytics) frequently (≥ 1 per week) in the last 12 months
* Medical situations limiting participation in the study: acute musculoskeletal pathologies (fractures, wounds, etc.) or local inflammatory processes, diagnosed psychiatric disease, vascular diseases (thrombosis), contagious diseases, fever, thermoregulation problems, incontinence, craniocerebral trauma or infarction (\< 6 months), thermal allergies, hypertension, or any uncontrolled systemic disease).

Primary outcomes:
measure: Balance of the autonomic nervous system upon waking
timeFrame: Measurement 1: Upon waking on the session day (6:00-7:00 a.m.); Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 4: Upon waking the day after session (6:00-7:00 a.m.); Measurement 5: 2
Secondary outcomes:
measure: Sleep satisfaction
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Hours of sleep
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Perception of well-being
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Mood
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Mental agility
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Distress
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Flexibility
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Functional capacity
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Fatigue
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Overall stress regulation
timeFrame: Measurement 1: Upon waking on the session day (6:00-7:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 4: Upon waking the day after session (6:00-7:00 a.m.).
measure: Systolic blood pressure
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Diastolic blood pressure
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Heart rate
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
measure: Blood oxygen saturation
timeFrame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 3: 5 minutes after session (10:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
Other outcomes:
measure: Attitude and beliefs towards holistic treatment
timeFrame: Measurement 0: At enrollment
measure: Previous experience participating in holistic therapeutic modalities.
timeFrame: Measurement 0: At enrollment
measure: Level of perceived stress
timeFrame: Measurement 0: At enrollment
measure: Resilience
timeFrame: Measurement 0: At enrollment
measure: Age
timeFrame: Measurement 0: At enrollment
measure: Place of Residence
timeFrame: Measurement 0: At enrollment
measure: Employment status
timeFrame: Measurement 0: At enrollment
measure: Marital Status
timeFrame: Measurement 0: At enrollment
measure: Level of Education
timeFrame: Measurement 0: At enrollment
measure: Family Income
timeFrame: Measurement 0: At enrollment
measure: Height
timeFrame: Measurement 0: At enrollment
measure: Weight
timeFrame: Measurement 0: At enrollment
measure: Waist Circumference
timeFrame: Measurement 0: At enrollment
measure: Hip Circumference
timeFrame: Measurement 0: At enrollment
measure: Waist-Hip Ratio
timeFrame: Measurement 0: At enrollment
measure: Drug consumption
timeFrame: Measurement 0: At enrollment
measure: Sedentary Behavior
timeFrame: Measurement 0: At enrollment
measure: Physical Activity Levels
timeFrame: Measurement 0: At enrollment
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References: