CClinicalTrials.gg
CompletedNCT00421070Updated Apr 28, 2015

Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit

An interventional study of Massage therapy in Psychiatric &or Mood Disorder, sponsored by Melbourne Health. Completed at 1 site in Australia. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2015-04-28.

Sponsored by Melbourne Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
15 Years to 25 Years
Sex
All
01

Study 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.

Read the detailed description

Patient aggression and agitation on psychiatric inpatient wards poses a significant problem for both staff and patients, and impairs the therapeutic environment of the ward. Relaxation massage therapy has previously been shown to reduce the level of arousal, stress, anxiety and aggression in adolescents/young adults with various psychiatric disorders including anxiety, depression, conduct disorder and bulimia. This project investigates whether relaxation massage therapy is an effective intervention treatment for the management of arousal and aggression on a young adult inpatient ward.

Two treatment conditions will be assessed at different times on the ward; a) standard (control) treatment as per usual and b) relaxation massage therapy intervention treatment in addition to the standard treatment. Each treatment condition will be implemented for a six-week period. Depending on admission rate, we estimate there will be approximately 50 participants in each treatment group. The massage therapy intervention treatment will consist of daily 20-minute, fully clothed, seated relaxation massage sessions, offered to all consenting patients during their period of hospitalization. We aim to determine whether relaxation massage therapy significantly reduces: i) the level of arousal, stress, anxiety, hostility and aggression in psychiatric inpatients; ii) the frequency and/or severity of aggressive incidents on the ward; iii) the need for sedating medication; iv) the need for patient seclusion and/or restraint; v) the mean duration of hospitalization and vi) the amount of sick leave taken by staff and the associated costs of running the ward. This will be assessed by pre- and post-massage therapy measures of heart rate and salivary cortisol levels; and staff and patient ratings of anxiety, hostility and aggression. The nature, frequency and severity of aggressive incidents on the ward, as well as the use of coercive measures during each treatment condition, will be assessed using the "Staff Observation Aggression Scale-Revised" (SOAS-R). Staff and patient perception of the atmosphere of the ward during each treatment condition will also be assessed using the "Ward Atmosphere Scale".

It is hypothesized 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, stress and/or anxiety among inpatients. It is further hypothesized that this will reduce the level of risk for both staff and patients and improve the therapeutic atmosphere of the ward. We also hypothesise that a reduction in aggressive incidents on the ward will be associated with a shorter mean duration of hospitalisation.

02

Conditions studied

  • Psychiatric &or Mood Disorder

Keywords

  • Aggression
  • Massage
  • Stress
  • Psychiatric inpatient
03

In context

Mood Disorders

584 studies on the registry are indexed under Mood Disorders; 117 are open to participants now.

This study's enrollment of 47 is below the median of 72 across 429 interventional studies indexed under Mood Disorders.

Browse Mood Disorders studies →

Lead sponsor

Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Admission to the ORYGEN Inpatient Unit

Exclusion criteria

Exclusion Criteria:

  • Highly agitated and aggressive patients remaining in a severely aggressive state for more than 24 hours after admission
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • No intervention
    Treatment as usual

    Observational component

  • Active comparator
    Intervention

    Massage therapy adjunct comparator

    Procedure: Massage therapy

Interventions

  • ProcedureMassage 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.

06

What researchers measure

Primary outcomes

  1. Aggression

    Time frame: 6 weeks

  2. Irritability

    Time frame: 6 weeks

  3. Anxiety

    Time frame: 6 weeks

  4. Depression

    Time frame: 6 weeks

  5. Cortisol levels

    Time frame: 6 weeks

Secondary outcomes

  1. Psychosocial climate

    Time frame: 6 weeks

  2. PRN medication

    Time frame: 6 weeks

  3. Incidence of seclusion or restraint

    Time frame: 6 weeks

  4. Duration of hospitalisation

    Time frame: 6 weeks

07

Study locations

1 site
  • ORYGEN Youth Health
    Melbourne, Victoria 3052, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00421070
Lead sponsor
Melbourne Health
Collaborators
National Health and Medical Research Council, Australia
Responsible party
Sponsor
First posted
Jan 11, 2007
Start date
May 2006
Primary completion
Sep 2006
Completion
Sep 2006
Last update
Apr 28, 2015

Study contacts

Belinda Garner, PhD
principal investigator · ORYGEN Research Centre, Department of Psychiatry, University of Melbourne
Lisa Phillips, M.Psych, PhD
principal investigator · Department of Psychology, University of Melbourne
Patrick D McGorry, PhD, FRANZP
study director · ORYGEN Research Centre , ORYGEN Youth Health, Department of Psychiatry, University of Melbourne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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