Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421070
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : April 28, 2015
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Melbourne Health

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.

Condition or disease Intervention/treatment Phase
Psychiatric &or Mood Disorder Procedure: Massage therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Arm Intervention/treatment
No Intervention: Treatment as usual
Observational component
Active Comparator: Intervention
Massage therapy adjunct comparator
Procedure: 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.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admission to the ORYGEN Inpatient Unit

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421070

Australia, Victoria
ORYGEN Youth Health
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Melbourne Health
National Health and Medical Research Council, Australia
Principal Investigator: Belinda Garner, PhD ORYGEN Research Centre, Department of Psychiatry, University of Melbourne
Principal Investigator: Lisa Phillips, M.Psych, PhD Department of Psychology, University of Melbourne
Study Director: Patrick D McGorry, PhD, FRANZP ORYGEN Research Centre , ORYGEN Youth Health, Department of Psychiatry, University of Melbourne

Responsible Party: Melbourne Health Identifier: NCT00421070     History of Changes
Other Study ID Numbers: HREC2005.060
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Melbourne Health:
Psychiatric inpatient

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders
Behavioral Symptoms