NCT05451888

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

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

June 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

June 16, 2022

Last Update Submit

May 25, 2023

Conditions

Mood

Outcome Measures

Primary Outcomes (2)

  • Positive Affect (chronic)

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

    Change between baseline and 8 weeks

  • Negative Affect (chronic)

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

    Change between Baseline and 8 weeks

Secondary Outcomes (6)

  • Subjective mood

    Change between baseline and 8 weeks

  • Subjective Stress

    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

  • +1 more secondary outcomes

Study Arms (3)

Celestial Floatation Pool

EXPERIMENTAL
Behavioral: Spa treatment

Dead Sea Salt Pool

EXPERIMENTAL
Behavioral: Spa treatment

Balneotherapy Control Pool

ACTIVE COMPARATOR
Behavioral: Spa treatment

Interventions

Spa treatmentBEHAVIORAL

A 40 minute period of lying in the spa treatment pool

Balneotherapy Control PoolCelestial Floatation PoolDead Sea Salt Pool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any adult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology

Reading, Berkshire, RG66AL, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Daniel Lamport

Study Record Dates

First Submitted

June 16, 2022

First Posted

July 11, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations

GB(1)