Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000020583
Ethics application status
Approved
Date submitted
3/10/2014
Date registered
15/01/2015
Date last updated
15/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of armchair with massage and relaxation program on recovery and health promotion in healthy employees - a randomized controlled study
Scientific title
Effect of armchair with massage and relaxation program on recovery and health promotion in healthy employees - a randomized controlled study
Secondary ID [1] 285441 0
'Nil known'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
workrelated negative stress-related illnesses 293203 0
Condition category
Condition code
Public Health 293603 293603 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study groups
In total, 93 employees participated in the study. Each participant was randomly assigned to one of the following study groups: i) Sitting in the armchair and use the massage program while listening to the mental training programs (n=19), ii) Sitting in the armchair and use the massage program only (n=19), iii) Sitting in the armchair and listen to the mental training programs only (n=19), iv) Sitting in the massage chair but not use either the massage program nor listen to the mental training program.

Study design
The study lasted for a total of 8 weeks. During these weeks the participants in group i-iii took a break for their regular work and sat in the chair for 15 minutes three times each week, preferably between at 13.00-16.00. The participants who used the massage program (i.e., group i and ii) all used the same massage program, but were able to make individual adjustment regarding the strength of the massage. The participants who listened to the mental training programs (i.e., group i and iii) listened to different programs in the following order: ”Recovery”-week one, “Mindfulness-learn to live in the present”, week two,“The way to a better and deeper sleep”-week three, “Reduce the negative stress” -week four., "Learn to think positively”-week five "Increase your mental strength”-week six, “How to get a greater enjoyment of life”-week seven and”Recovery”-week eight.

The participants in group iv took a break from their regular work and sat in the chair for 15 minutes three times each week, however they did not use neither the massage program nor listen to the mental training programs. Group v served as a control group and continued their work as usual. The intervention was followed by the participants kept a diary throughout the study period. They described, for example, technical questions regarding the treatment, experiences of treatment, disease. In three of the workplaces the participants choose themselves when to use the chair. In the fourth workplace, due to a hectic schedule, the participants were assigned specific time points when to use the chair.


Intervention code [1] 290373 0
Other interventions
Comparator / control treatment
v) Not sitting in the armchair at all (control group) (n=17). Group v served as a control group and continued their work as usual.
Control group
Active

Outcomes
Primary outcome [1] 293300 0
First primary outcomes is the effects for employees’ experienced psychologicall health

The statements included in the questionnaire are part of the larger questionnaire “the Swedish Scale of Personality” (SSP). SSP is a revised form of the previous “Karolinska Scale of Personality” (KSP). In this updated form the scales have been shortened, modernized and psychometrically evaluated. The SSP has been evaluated for more than 3000 individuals including more than 1000 patients. SSP contains 13 subscales where each subscale has seven statements with a four point response format, ranging from “does not apply at all” to “apply completely” (Gustavsson et al., 2000). In the present study the following five subscales, and corresponding items, were included: “Somatic Trait Anxiety” (STA), “Psychic Trait Anxiety” (PSTA), “Stress Susceptibility” (SS), “Detachment” (D) and “Social Desirability” (SD).

Timepoint [1] 293300 0
Before the study started, after 4 and 8 weeks
Secondary outcome [1] 310980 0
Second outcomes is the effects for employees’ physiological health.
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured by using an automatic manometer that is clinically validated and approved in accordance with the protocols of the International Society of Hypertension. (Omron M6 Comfort, Omron Healthcare, Hoofddorp, the Netherlands). The manometer was attached on the participants’ left arm and placed in line with the heart.
Timepoint [1] 310980 0
Before the study started, after 4 and 8 weeks
Secondary outcome [2] 312068 0
Heart rate variability was measured during for 5 minutes using with a Heart rhythm scanner (Biocom 4000, Biocom Ttechnologies, Poulbo, USA) according to the manufacturer’s instructions.
Timepoint [2] 312068 0
Before the study started, after 4 and 8 weeks
Secondary outcome [3] 312071 0
Fingertip temperature was measured by with a laser thermometer (Digital-Laser Thermometer, Esska.de GmbH, Hamburg, Germany). The participants were in a seated position during all measurements.
Timepoint [3] 312071 0
Before the study started, after 4 and 8 weeks
Secondary outcome [4] 312222 0
Oxytocin
Timepoint [4] 312222 0
Before the study started, after 4 and 8 weeks, by serum assay
Secondary outcome [5] 312335 0
Cortisol
Timepoint [5] 312335 0
Before the study started, after 4 and 8 weeks, by serum assay

Eligibility
Key inclusion criteria
Healthy employees (i.e., without self-reported serious and/or chronic illnesses and able to perform their work assignment) with no previous experience of using mechanical massage chair and/or the mental training program were asked if they wanted to participate in the study.
Minimum age
19 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Employees who suffered from fever, skin diseases, kidney disease as well as pregnant women were excluded from the study due to health risks.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Background data are presented as mean and standard deviation (SD) in order to compare similar studies Since the number of participant in each group was relatively small a normal distribution could not be taken for granted and non-parametric statistical test were used to analyse the results. The Kruskal Wallis Test for independent samples, as well as the Mann-Whitney test for independent samples, was used to test for the differences between groups at single time points /start, four weeks and eight weeks). Friedman’s Two-way Analysis of variance by rank was used to test for differences within each study group during the entire study period. Wilcoxon signed rank test was used to test for differences between two time-points within each study group. Changes between start and four weeks, between four and eight weeks, as well as between start and eight weeks were analysed. P-values <0.05 were considered significant and P-values < 0.1 were interpreted as a tendency.


Calculation of estimated number of participants were performed based on the results of previous studies using KSP [1, 2]

1. Jonas W, Nissen E, Ransjo-Arvidson AB, Matthiesen AS, Uvnas-Moberg K: Influence of oxytocin or epidural analgesia on personality profile in breastfeeding women: a comparative study. Arch Womens Ment Health 2008, 11:335-345.
2. Nissen E, Gustavsson P, Widstrom AM, Uvnas-Moberg K: Oxytocin, prolactin, milk production and their relationship with personality traits in women after vaginal delivery or Cesarean section. J Psychosom Obstet Gynaecol 1998, 19:49-58.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2013
Actual
1/04/2013
Date of last participant enrolment
Anticipated
31/12/2013
Actual
1/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 6389 0
Sweden
State/province [1] 6389 0

Funding & Sponsors
Funding source category [1] 290047 0
Charities/Societies/Foundations
Name [1] 290047 0
KK foundation
Country [1] 290047 0
Sweden
Funding source category [2] 290048 0
Commercial sector/Industry
Name [2] 290048 0
Promas AB
Country [2] 290048 0
Sweden
Funding source category [3] 290049 0
University
Name [3] 290049 0
Scandinavian International University. This is a privat school and a funder of the project
Country [3] 290049 0
Sweden
Primary sponsor type
University
Name
University of Skovde
Address
Box 408, S-541 28 Skovde
Country
Sweden
Secondary sponsor category [1] 288736 0
Commercial sector/Industry
Name [1] 288736 0
Alviva
Address [1] 288736 0
VLM, avd AA99000, 405 08 Goteborg
Country [1] 288736 0
Sweden

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 51890 0
A/Prof Anette Ekstrom
Address 51890 0
School of Health and Education
University of Skovde
Box 408, S-541 28 Skovde
Country 51890 0
Sweden
Phone 51890 0
+46 500 44 84 14
Fax 51890 0
Email 51890 0
[email protected]
Contact person for public queries
Name 51891 0
Linda Handlin
Address 51891 0
School of Health and Education
University of Skovde
Box 408, S-541 28 Skovde
Country 51891 0
Sweden
Phone 51891 0
+ 46 500 44 83 68
Fax 51891 0
Email 51891 0
[email protected]
Contact person for scientific queries
Name 51892 0
Linda Handlin
Address 51892 0
School of Health and Education
University of Skovde
Box 408, S-541 28 Skovde
Country 51892 0
Sweden
Phone 51892 0
+ 46 500 44 83 68
Fax 51892 0
Email 51892 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
EmbaseMechanical massage and mental training programmes affect employees' anxiety, stress susceptibility and detachment-a randomised explorative pilot study.2015https://dx.doi.org/10.1186/s12906-015-0753-x
Dimensions AIThe Effect of Mechanical Massage and Mental Training on Heart Rate Variability and Cortisol in Swedish Employees—A Randomized Explorative Pilot Study2020https://doi.org/10.3389/fpubh.2020.00082
N.B. These documents automatically identified may not have been verified by the study sponsor.