EFFECT of HAMMAM EXPERIENCE on GENERAL HEALTH and PERCEIVED WELL-BEING

Not Applicable

Active, not recruiting

• Conditions: Chronic Stress; Wellness; General Health

• Registration Number: NCT06788041
• Lead Sponsor: Universidad de Granada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2024-12-07
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-04-30
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Balance of the autonomic nervous system upon waking	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	Evaluated through heart rate variability upon waking up. It will always be performed under the same conditions in an unlit, quiet environment without noise/distractions, with the person in supine position and after emptying the bladder. A total time of 5 min will be recorded through H-10 polar band.

Secondary Outcome Measures

Name	Time	Method
Heart rate	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.).	Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer
Sleep satisfaction	Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).	Assessed through a Likert scale in which 0 corresponds to the option "Not all all satisfactory" and 10 with "Very satisfactory"
Hours of sleep	Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).	Assessed through an open question in which participants are asked "What time did you go to bed to sleep?", "What time did you wake up in the morning?" and "How many hours and minutes do you think you slept in total at night?"
Perception of well-being	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.).	Assessed with the EBS-8 subjective well-being scale, which assesses the two components of well-being: life satisfaction and positive affect and with a visual analog scale 0-10.
Mood	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.).	The Mood Rating Scale (EVEA) will be used, which evaluates mood states with a range from 0 to 10 and as a time reference "right now". It consists of 4 subscales: sadness-depression, anxiety, anger-hostility and joy.
Mental agility	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.).	Assessed by the "Trail Marking Test", which assesses t used to evaluate attention, flexibility of thought and visuospatial ability. It consists of two parts. In both cases, the subject will need a pencil and the evaluator a stopwatch, counting the execution time for each of the parts as soon as the pertinent indications have been given. In part A, the participant will join in ascending order all the numbers from 1 to 25 arranged on a sheet of paper. In exercise B, the process will be repeated, but alternating letters and numbers in alphanumeric order. In both cases, the time spent will be quantified.
Distress	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.).	Assessed through a distress thermometer, a likert scale in which 0 corresponds to the option "No distress" and 10 with "Extreme distress"
Flexibility	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.).	The "sit and reach" test will be performed, for the evaluation of flexibility in which the subject, who is seated on the edge of a chair (placed against a wall for safety reasons), and one foot resting on the sleep, will extend the other leg forward with the knee straight, the heel resting on the sleep and the ankle at 90º, placing one hand on top of the other with the tips of the central fingers equal. The participant will be instructed to inhale and, on exhalation, extend the hand forward toward the toes by bending at the hip. The distance will be measured between the fingertips and toes so that, if the fingertips touch the toes, the score is 0, if they do not touch, the resulting distance in cm will be negative and, if they overlap, we are talking about a distance in cm positive.
Functional capacity	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.).	With the sit-to-stand test 30 seconds, which measures how many times a person can transition from sitting in a chair to standing and back to sitting within 30 seconds.
Fatigue	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.).	After completing the 30-second sit-to-stand test, participants rate their perceived level of fatigue using the Borg CR10 scale. This scale ranges from 0 (no fatigue at all) to 10 (extreme fatigue) and provides a subjective measure of exertion following the activity.
Overall stress regulation	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.).	Salivary samples will be collected first thing in the morning, using a timer and ensuring the entire sample is collected within three minutes. Without ingestion of caffeine and/or stimulant substances 12 hours before, as well as with complete oral hygiene (dental brushing and use of mouthwash, preferably) the night before.; Salivary samples (400µL) will be collected in specific collection kits for 2ml salivary sample and cryovials (Salimetrics, LLC, Carlsbad, United States), to proceed to their subsequent immediate freezing at -80ºC until the pertinent analysis of cortisol through ELISA is performed.
Systolic blood pressure	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.).	Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer.
Diastolic blood pressure	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.).	Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer.
Blood oxygen saturation	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.).	Measured using a pulse oximeter placed on the fingertip, ensuring the patient is seated and at rest for at least 10 minutes prior to measurement.

Trial Locations

Locations (1)

University of Granada; 🇪🇸 Granada, Spain