NCT06788041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

December 7, 2024

Last Update Submit

November 15, 2025

Conditions

Keywords

hammanbalneotherapymassagechronic stressgeneral healthwellness

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).

  • Hours of sleep

    Measurement 2: 30 minutes before session (8:00 a.m.); Measurement 5: 24 hours post-session (8:00 a.m.).

  • 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.).

  • 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.).

  • 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.).

  • +9 more secondary outcomes

Other Outcomes (18)

  • Attitude and beliefs towards holistic treatment

    Measurement 0: At enrollment

  • Previous experience participating in holistic therapeutic modalities.

    Measurement 0: At enrollment

  • Level of perceived stress

    Measurement 0: At enrollment

  • +15 more other outcomes

Study Arms (6)

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.

Other: Hamman experienceOther: MassageOther: Placebo Comparator

Arm 2 (ACB)

EXPERIMENTAL
Other: Hamman experienceOther: MassageOther: Placebo Comparator

ARM 3 (BAC)

EXPERIMENTAL
Other: Hamman experienceOther: MassageOther: Placebo Comparator

Arm 4 (BCA)

EXPERIMENTAL
Other: Hamman experienceOther: MassageOther: Placebo Comparator

Arm 5 (CAB)

EXPERIMENTAL
Other: Hamman experienceOther: MassageOther: Placebo Comparator

Arm 6 (CBA)

EXPERIMENTAL
Other: Hamman experienceOther: MassageOther: Placebo Comparator

Interventions

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.

Also known as: Balneotherapy and massage
ARM 3 (BAC)Arm 1 (ABC)Arm 2 (ACB)Arm 4 (BCA)Arm 5 (CAB)Arm 6 (CBA)
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.

ARM 3 (BAC)Arm 1 (ABC)Arm 2 (ACB)Arm 4 (BCA)Arm 5 (CAB)Arm 6 (CBA)

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.

ARM 3 (BAC)Arm 1 (ABC)Arm 2 (ACB)Arm 4 (BCA)Arm 5 (CAB)Arm 6 (CBA)

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18016, Spain

Location

MeSH Terms

Interventions

BalneologyMassage

Intervention Hierarchy (Ancestors)

TherapeuticsTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 7, 2024

First Posted

January 22, 2025

Study Start

September 1, 2024

Primary Completion

April 30, 2025

Study Completion

November 15, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations