Chronic StressNCT06788041
EFFECT OF HAMMAM EXPERIENCE ON GENERAL HEALTH AND PERCEIVED WELL-BEING
A study testing Hamman experience and Massage in people with Chronic Stress and Wellness, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Chronic Stress, Wellness, General Health
- What is being tested?
- Hamman experience and Massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Chronic Stress, Wellness, General Health
- Being tested
- Hamman experience, Massage, Placebo Comparator
- Keywords
- hamman, balneotherapy, massage, chronic stress, general health, wellness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamman experienceOther
Also called Balneotherapy and massage
There will be a circuit in the Hammam Al Andalus baths with baths in all pools (warm, hot or cold water) and sauna for 30 minutes. The time in each pool will be determined by the sensation and tolerance of each participant. In addition, participants will receive foam with aromatic oils on the participant's body (arms, trunk and legs). This foam will be left for about 10 minutes on the participant's body, while a manual body therapy is performed. The force to be applied will be very weak, a superficial rubbing will be performed to prepare the tissue, followed by a maintained pressure and then sliding pressures are performed. The application time should not exceed 15 minutes.
MassageOther
Duration of 45 minutes. A complete dorsal and ventral body massage will be performed, with superficial maneuvers at a slow pace of traditional massage.
Placebo ComparatorOther
The person will be instructed to stay for 45 minutes during which he/she will receive different electrotherapy techniques with the devices disconnected, a mobile device that simulates a beep will be placed so that the patient believes that the device is connected.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (ABC) | Experimental | Participants in this arm will rotate through three treatments (Treatment A Hamman experience and massage, Treatment B massage only, and Treatment C placebo) in a randomized sequence. Each treatment will be separated by a washout period to minimize carryover effects. All participants will experience each treatment at different periods, serving as their own control. Receives: Other: Hamman experience; Other: Massage; Other: Placebo Comparator |
| Arm 2 (ACB) | Experimental | Not described Receives: Other: Hamman experience; Other: Massage; Other: Placebo Comparator |
| ARM 3 (BAC) | Experimental | Not described Receives: Other: Hamman experience; Other: Massage; Other: Placebo Comparator |
| Arm 4 (BCA) | Experimental | Not described Receives: Other: Hamman experience; Other: Massage; Other: Placebo Comparator |
| Arm 5 (CAB) | Experimental | Not described Receives: Other: Hamman experience; Other: Massage; Other: Placebo Comparator |
| Arm 6 (CBA) | Experimental | Not described Receives: Other: Hamman experience; Other: Massage; Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance of the autonomic nervous system upon waking
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.
Measured: 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 (14)
Sleep satisfaction
Assessed through a Likert scale in which 0 corresponds to the option "Not all all satisfactory" and 10 with "Very satisfactory"
Measured: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
Hours of sleep
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?"
Measured: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
Perception of well-being
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.
Measured: 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.).
Mood
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.
Measured: 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.).
Mental agility
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.
Measured: 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.).
Distress
Assessed through a distress thermometer, a likert scale in which 0 corresponds to the option "No distress" and 10 with "Extreme distress"
Measured: 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.).
Flexibility
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.
Measured: 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.).
Functional capacity
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.
Measured: 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.).
Fatigue
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.
Measured: 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.).
Overall stress regulation
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.
Measured: 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.).
Systolic blood pressure
Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer.
Measured: 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.).
Diastolic blood pressure
Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer.
Measured: 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.).
Heart rate
Measured with the patient seated after at least 10 minutes of rest using a sphygmomanometer
Measured: 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.).
Blood oxygen saturation
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.
Measured: 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.).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Sep 2024
- Primary completion30 Apr 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- AL ÁNDALUS BAÑOS ÁRABES (Hammam Granada)
- Responsible party
- Principal investigator, Irene Cantarero Villanueva, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788041
- Sponsor's protocol ID
- HAM24
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06788041
- Acronym / sponsor ID
- HAM24
- Conditions
- Chronic Stress, Wellness, General Health
- Keywords
- hamman, balneotherapy, massage, chronic stress, general health, wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- AL ÁNDALUS BAÑOS ÁRABES (Hammam Granada)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (ABC) | Experimental | Other: Hamman experience, Other: Massage, Other: Placebo ComparatorParticipants in this arm will rotate through three treatments (Treatment A Hamman experience and massage, Treatment B massage only, and Treatment C placebo) in a randomized sequence. Each treatment will be separated by a washout period to minimize carryover effects. All participants will experience each treatment at different periods, serving as their own control. |
| Arm 2 (ACB) | Experimental | Other: Hamman experience, Other: Massage, Other: Placebo Comparator |
| ARM 3 (BAC) | Experimental | Other: Hamman experience, Other: Massage, Other: Placebo Comparator |
| Arm 4 (BCA) | Experimental | Other: Hamman experience, Other: Massage, Other: Placebo Comparator |
| Arm 5 (CAB) | Experimental | Other: Hamman experience, Other: Massage, Other: Placebo Comparator |
| Arm 6 (CBA) | Experimental | Other: Hamman experience, Other: Massage, Other: Placebo Comparator |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamman experienceAlso: Balneotherapy and massageThere will be a circuit in the Hammam Al Andalus baths with baths in all pools (warm, hot or cold water) and sauna for 30 minutes. The time in each pool will be determined by the sensation and tolerance of each participant. In addition, participants will receive foam with aromatic oils on the participant's body (arms, trunk and legs). This foam will be left for about 10 minutes on the participant's body, while a manual body therapy is performed. The force to be applied will be very weak, a superficial rubbing will be performed to prepare the tissue, followed by a maintained pressure and then sliding pressures are performed. The application time should not exceed 15 minutes. | Other | ARM 3 (BAC), Arm 1 (ABC), Arm 2 (ACB), Arm 4 (BCA), Arm 5 (CAB), Arm 6 (CBA) |
| MassageDuration of 45 minutes. A complete dorsal and ventral body massage will be performed, with superficial maneuvers at a slow pace of traditional massage. | Other | ARM 3 (BAC), Arm 1 (ABC), Arm 2 (ACB), Arm 4 (BCA), Arm 5 (CAB), Arm 6 (CBA) |
| Placebo ComparatorThe person will be instructed to stay for 45 minutes during which he/she will receive different electrotherapy techniques with the devices disconnected, a mobile device that simulates a beep will be placed so that the patient believes that the device is connected. | Other | ARM 3 (BAC), Arm 1 (ABC), Arm 2 (ACB), Arm 4 (BCA), Arm 5 (CAB), Arm 6 (CBA) |
Primary outcome
Balance of the autonomic nervous system upon waking
Time frame: 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.
14 secondary outcomes
Sleep satisfaction
Time frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
Hours of sleep
Time frame: Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).
Perception of well-being
Time frame: 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.).
Mood
Time frame: 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.).
Mental agility
Time frame: 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.).
Distress
Time frame: 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.).
Flexibility
Time frame: 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.).
Functional capacity
Time frame: 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.).
Fatigue
Time frame: 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.).
Overall stress regulation
Time frame: 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.).
Systolic blood pressure
Time frame: 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.).
Diastolic blood pressure
Time frame: 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.).
Heart rate
Time frame: 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.).
Blood oxygen saturation
Time frame: 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.).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hamman experience and Massage in people with Chronic Stress and Wellness, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance of the autonomic nervous system upon waking (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.