Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00421070
First received: January 10, 2007
Last updated: April 26, 2015
Last verified: April 2015

January 10, 2007
April 26, 2015
May 2006
September 2006   (final data collection date for primary outcome measure)
  • Aggression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Irritability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Cortisol levels [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Aggression
  • Irritability
  • Anxiety
  • Depression
  • Cortisol levels
Complete list of historical versions of study NCT00421070 on ClinicalTrials.gov Archive Site
  • Psychosocial climate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • PRN medication [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Incidence of seclusion or restraint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Duration of hospitalisation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Psychosocial climate
  • PRN medication
  • Incidence of seclusion or restraint
  • Duration of hospitalisation
Not Provided
Not Provided
 
Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Psychiatric &or Mood Disorder
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.
  • No Intervention: Treatment as usual
    Observational component
  • Active Comparator: Intervention
    Massage therapy adjunct comparator
    Intervention: Procedure: Massage therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
15 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00421070
HREC2005.060
No
Melbourne Health
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
Melbourne Health
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP