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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00421070




Registration number
NCT00421070
Ethics application status
Date submitted
10/01/2007
Date registered
11/01/2007
Date last updated
28/04/2015

Titles & IDs
Public title
Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit
Scientific title
The Evaluation of Relaxation Massage Therapy as an Intervention Treatment for Reducing the Level of Arousal and Aggression on a Young Adult Psychiatric Inpatient Unit
Secondary ID [1] 0 0
HREC2005.060
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychiatric &or Mood Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Massage therapy

No intervention: Treatment as usual - Observational component

Active comparator: Intervention - Massage therapy adjunct comparator


Treatment: Surgery: Massage therapy
A qualified massage therapist will administer a 20-minute standard massage procedure with the client sitting fully clothed in a special massage chair. The massage therapy session will consist of ; 1) long, broad stroking with light-moderate pressure to the back, compression to the back (parallel to spine) from the shoulders to base of spine, trapezius squeeze, finger pressure on the shoulder; 2) arms dropped to the side with arms kneaded from shoulder to lower arm and pressing down on upper and lower arms; 3) entire hands massaged and pulling of fingers, light kneading to area of cervical vertebrae, pressing down on trapezius with finger pressure and squeezing continuing down the arms.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Aggression
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Irritability
Timepoint [2] 0 0
6 weeks
Primary outcome [3] 0 0
Anxiety
Timepoint [3] 0 0
6 weeks
Primary outcome [4] 0 0
Depression
Timepoint [4] 0 0
6 weeks
Primary outcome [5] 0 0
Cortisol levels
Timepoint [5] 0 0
6 weeks
Secondary outcome [1] 0 0
Psychosocial climate
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
PRN medication
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Incidence of seclusion or restraint
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Duration of hospitalisation
Timepoint [4] 0 0
6 weeks

Eligibility
Key inclusion criteria
* Admission to the ORYGEN Inpatient Unit
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Highly agitated and aggressive patients remaining in a severely aggressive state for more than 24 hours after admission

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
ORYGEN Youth Health - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate whether relaxation massage therapy is effective in reducing the levels of arousal and aggression on a young adult inpatient unit. It is hypothesised that relaxation massage therapy will lead to a lower incidence of violence and aggression on the ward via a reduction in the level of arousal and anxiety among inpatients.
Trial website
https://clinicaltrials.gov/study/NCT00421070
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Belinda Garner, PhD
Address 0 0
ORYGEN Research Centre, Department of Psychiatry, University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00421070