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Clinical Trials/NCT00421070
NCT00421070
Completed
Not Applicable

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

Melbourne Health1 site in 1 country47 target enrollmentMay 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychiatric &or Mood Disorder
Sponsor
Melbourne Health
Enrollment
47
Locations
1
Primary Endpoint
Anxiety
Status
Completed
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
September 2006
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Anxiety

Time Frame: 6 weeks

Cortisol levels

Time Frame: 6 weeks

Depression

Time Frame: 6 weeks

Aggression

Time Frame: 6 weeks

Irritability

Time Frame: 6 weeks

Secondary Outcomes

  • Psychosocial climate(6 weeks)
  • Duration of hospitalisation(6 weeks)
  • Incidence of seclusion or restraint(6 weeks)
  • PRN medication(6 weeks)

Study Sites (1)

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