ANALYSIS OF THE EFFECT OF HAMMAM EXPERIENCE ON GENERAL HEALTH AND PERCEIVED WELL-BEING COMPARED TO MASSAGE AND PLACEBO : A RANDOMIZED CROSS-SECTIONAL STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Balance of the autonomic nervous system upon waking
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Arm 4 (BCA)
干预措施: Hamman experience (Other)
Arm 4 (BCA)
干预措施: Massage (Other)
Arm 4 (BCA)
干预措施: Placebo Comparator (Other)
Arm 5 (CAB)
干预措施: Hamman experience (Other)
Arm 5 (CAB)
干预措施: Massage (Other)
Arm 5 (CAB)
干预措施: Placebo Comparator (Other)
Arm 6 (CBA)
干预措施: Hamman experience (Other)
Arm 6 (CBA)
干预措施: Massage (Other)
Arm 6 (CBA)
干预措施: Placebo Comparator (Other)
Arm 1 (ABC)
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.
干预措施: Hamman experience (Other)
Arm 1 (ABC)
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.
干预措施: Massage (Other)
Arm 1 (ABC)
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.
干预措施: Placebo Comparator (Other)
Arm 2 (ACB)
干预措施: Hamman experience (Other)
Arm 2 (ACB)
干预措施: Massage (Other)
Arm 2 (ACB)
干预措施: Placebo Comparator (Other)
ARM 3 (BAC)
干预措施: Hamman experience (Other)
ARM 3 (BAC)
干预措施: Massage (Other)
ARM 3 (BAC)
干预措施: Placebo Comparator (Other)
结局指标
主要结局
Balance of the autonomic nervous system upon waking
时间窗: 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.
次要结局
- 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.).)
- 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.).)
- 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.).)
- 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.).)
- 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.).)
- 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.).)
- 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.).)
- 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.).)
- 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.).)
- 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.).)
研究者
Irene Cantarero Villanueva
Professor
Universidad de Granada