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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
NA
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00421070