跳至主要内容
临床试验/NCT05451888
NCT05451888已完成不适用

Assessing Effects of Mineral-rich Floatation Spa Treatment on Mood and Psychological Health Outcomes

University of Reading2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Positive Affect (chronic)

研究概览

简要总结

This is a randomised parallel groups trial in healthy human adults exploring whether 8 weeks of treatment in various different spa pools is associated with benefits for mood and other psychological outcomes. Outcome measures will be taken at the beginning and the end of the 8 week period. In addition, outcome measures will be taken after the first spa session to assess acute effects.

详细描述

This experiment is investigating whether mineral-rich floatation spa treatments influence mood and psychological health outcomes. The study will be undertaken at Nirvana Spa in Wokingham over a duration of 8 weeks for each participant. Participants will be randomly allocated to one of three experimental groups. Each group will be assigned to a different mineral-rich spa treatment pool; either a Celestial Floatation pool, Dead Sea Salt Therapy pool, or a control pool which does not contain any minerals (Balneotherapy pool). Participants will undergo one 40-minute treatment, once a week for 8 weeks. The recommended duration for Dead Sea Salt and Celestial floatation pool sessions are 30-40 minutes, thus this study will reflect everyday consumer behaviour. A follow-up assessment of the outcome measures will take place 2 weeks after cessation of treatment to assess possible carry-over effects.

Specifically, there are four research aims of the study;

  1. To investigate the effects of regular weekly treatment in the Celestial Floatation Pool on mood outcomes including positive and negative affect, anxiety, depression, and stress.
  2. To investigate the effects of regular weekly treatment in the Dead Sea Salt Therapy pool on mood outcomes including positive and negative affect, anxiety, depression, and stress.
  3. To investigate the effects of a single 40-minute treatment in the Celestial Floatation Pool and the Dead Sea Salt Therapy pool on mood outcomes including positive and negative affect, anxiety and stress.
  4. Do any beneficial effects of spa treatment persist beyond cessation of treatment?

Outcome measures will be used to assess mood and psychological health outcomes both at the beginning (baseline) and at the end (8 weeks) of each treatment (see procedures). In addition, outcome measures will be taken immediately after the first spa treatment to assess acute effects. Specifically, the outcome measures are:

  • Positive and Negative Affect using the PANAS-X. This will be a well-established measure of how positive and negative an individual is feeling (these are two separate outcome measures).
  • Subjective mood with the Immediate Mood Scaler. This is a recently published novel 22-item measure developed to assess dynamic components of mood. Participants rate their current mood state on a continuum using 7-point Likert scales (eg, happy-sad, distracted-focused, sleepy-alert, fearful-fearless. For each item, an integer score between 1 and 7 is derived. The total score for this scale is the sum of the scores on all 22 items.
  • Stress using the Perceived Stress Scale.
  • Anxiety with the GAD-7 and the Spielberger State Anxiety Inventory.
  • Depression with the PHQ-8
  • Sleep quality with the Pittsburgh Sleep Quality Index (PSQI)
  • Experience of spa use will be captured using qualitative and quantitative questions on their enjoyment of the spa intervention and ease of use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Any diagnosed mental health conditions or physical conditions/injuries (including those still undergoing physiotherapy for a previous condition or injury), arthritis and previous regular use of spa treatments which is defined as use of spa facilities once a month or more over the previous 8 weeks. The rational for these exclusion criteria is that the spa is known to benefit injury and joint pain recovery. This is not a mechanism of interest for this study, therefore we want to exclude these participants.

结局指标

主要结局

Positive Affect (chronic)

时间窗: Change between baseline and 8 weeks

This will be a well-established measure of how positive an individual is feeling measured using the PANAS-X questionnaire

Negative Affect (chronic)

时间窗: Change between Baseline and 8 weeks

This will be a well-established measure of how negative an individual is feeling measured using the PANAS-X questionnaire

次要结局

  • Subjective Stress(Change between baseline and 8 weeks)
  • Subjective mood(Change between baseline and 8 weeks)
  • Anxiety(Change between baseline and 8 weeks)
  • Depression(Change between baseline and 8 weeks)
  • Sleep Quality(Change between Baseline and 8 weeks)
  • Subjective experience of the spa(At 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Lamport

Associate Professor Daniel Lamport

University of Reading

研究点 (2)

Loading locations...

相似试验