Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000483752
Ethics application status
Approved
Date submitted
26/04/2013
Date registered
30/04/2013
Date last updated
30/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Beneficial effects of treatment with sensory isolation in flotation-tank as a health-care intervention
Scientific title
Effects of treatment with sensory isolation in flotation-tank as a health-care intervention for healthy persons working full-time: effects on stress,energy, pain, anxiety, depression, sleep quality, mindfulness, and degree of altered states of consciousness
Secondary ID [1] 282403 0
nil
Universal Trial Number (UTN)
U1111-1142-1285
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 288984 0
pain 288985 0
general quality of life 288986 0
anxiety 288998 0
depression 288999 0
Condition category
Condition code
Alternative and Complementary Medicine 289327 289327 0 0
Other alternative and complementary medicine
Mental Health 289345 289345 0 0
Depression
Mental Health 289361 289361 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is relaxation in a flotation tank. This tank is a device filled with magnesium sulphate (Epsom salt) saturated water (1.3 g/cm^3) heated to 35-36 degrees Celsius. In the tank there is darkness and silence. Ear-plugs are used.

The participants receive a total of twelve flotation sessions (each consisting of 45 minutes) during seven weeks. There is one session every 3-4 days over the 7 week intervention period. There is a session attendance monitoring at the floatation tank centre. If a participant do not arrive, or get sick, a new scheduled session is offered.
Intervention code [1] 287037 0
Other interventions
Comparator / control treatment
persons on waiting list for floatation tank is control group. They will be offered the interventions about 8 weeks later.
Control group
Active

Outcomes
Primary outcome [1] 289437 0
depression < 6 HAD-scale
Timepoint [1] 289437 0
before and after 7 weeks
Primary outcome [2] 289438 0
anxiety < 6 HAD-scale
Timepoint [2] 289438 0
before and after 7 weeks
Primary outcome [3] 289439 0
stress SE-scale
Timepoint [3] 289439 0
before and after 7 weeks
Secondary outcome [1] 302474 0
energy SE-scale
Timepoint [1] 302474 0
before and after 7 weeks
Secondary outcome [2] 302475 0
pain, worst pain, normal pain VAS-scales.
Timepoint [2] 302475 0
before and after 7 weeks
Secondary outcome [3] 302476 0
degree of Mindfulness, MAAS-scale
Timepoint [3] 302476 0
before and after 7 weeks
Secondary outcome [4] 302477 0
optimism LOT-scale
Timepoint [4] 302477 0
before and after 7 weeks
Secondary outcome [5] 302478 0
sleep quality SQ-scale
Timepoint [5] 302478 0
before and after 7 weeks
Secondary outcome [6] 302479 0
experience of altered states of consciousness, EDN-scale (for experimental group only)
Timepoint [6] 302479 0
3 weeks, 7 weeks

Eligibility
Key inclusion criteria
interested in participating, working full time
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnancy, open wounds

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An agreement was made between the owner of a flotation centre and three managers from three different companies about a health-care program involving flotation-tank treatments. All three companies advertised through intranet correspondence, their company magazines, and through emails, offering all employees to participate in the health-care program. All interested participants were invited to an information meeting at the flotation centre, where they were further informed about the program. Information was given that the flotation-rest program would enable them to participate in a scientific study concerning the effects of this treatment program. Further information was given regarding that the participation was voluntary, confidential, that they would be randomly selected to either experimental group or waiting list, and that they could terminate their participation at any given point. They were also informed it was possible to participate in the health-care program without participation in the present study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
at the first meeting, the participant pulled a "lottery ticket" out of a closed box. It was written "floatation-tank" or "waiting list" on this ticket.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
MANOVA, repeated measure ANOVA.
From earlier studies with relaxation in flotation tank (flotation-REST) we know that for htese variables and the study design about 20 persons in each group is sufficient for an effect-size (Eta2) of 0,70 and p < 0.001, and a power of 0.98

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
2/08/2010
Date of last participant enrolment
Anticipated
7/03/2011
Actual
17/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment outside Australia
Country [1] 5048 0
Sweden
State/province [1] 5048 0

Funding & Sponsors
Funding source category [1] 287176 0
Self funded/Unfunded
Name [1] 287176 0
no funding
Country [1] 287176 0
Primary sponsor type
University
Name
Karlstad University
Address
Karlstad University
Dept of Psychology
SE-651 88 Karlstad, Sweden
Country
Sweden
Secondary sponsor category [1] 285941 0
None
Name [1] 285941 0
Address [1] 285941 0
Country [1] 285941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289172 0
Karlstad University Review board
Ethics committee address [1] 289172 0
Ethics committee country [1] 289172 0
Sweden
Date submitted for ethics approval [1] 289172 0
Approval date [1] 289172 0
Ethics approval number [1] 289172 0
C2013/262

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39594 0
Prof Anette Kjellgren
Address 39594 0
Karlstad University
Dept of Psychology
SE-651 88 Karlstad
Country 39594 0
Sweden
Phone 39594 0
+46 54 700 21 73
Fax 39594 0
Email 39594 0
[email protected]
Contact person for public queries
Name 39595 0
Anette Kjellgren
Address 39595 0
Karlstad University
Dept of Psychology
SE-651 88 Karlstad
Country 39595 0
Sweden
Phone 39595 0
+46 54 700 21 73
Fax 39595 0
Email 39595 0
[email protected]
Contact person for scientific queries
Name 39596 0
Anette Kjellgren
Address 39596 0
Karlstad University
Dept of Psychology
SE-651 88 Karlstad
Country 39596 0
Sweden
Phone 39596 0
+46 54 700 21 73
Fax 39596 0
Email 39596 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBeneficial effects of treatment with sensory isolation in flotation-tank as a preventive health-care intervention - a randomized controlled pilot trial.2014https://dx.doi.org/10.1186/1472-6882-14-417
N.B. These documents automatically identified may not have been verified by the study sponsor.