Clinical trial NCT00421070: Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric &or Mood Disorder
Keywords: Aggression
Massage
Stress
Psychiatric inpatient
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2007-01-11
Enrollment: 47
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Aggression
timeFrame: 6 weeks
measure: Irritability
timeFrame: 6 weeks
measure: Anxiety
timeFrame: 6 weeks
measure: Depression
timeFrame: 6 weeks
measure: Cortisol levels
timeFrame: 6 weeks
Secondary outcomes:
measure: Psychosocial climate
timeFrame: 6 weeks
measure: PRN medication
timeFrame: 6 weeks
measure: Incidence of seclusion or restraint
timeFrame: 6 weeks
measure: Duration of hospitalisation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: ORYGEN Youth Health
state: Victoria
Study officials:
affiliation: ORYGEN Research Centre, Department of Psychiatry, University of Melbourne
name: Belinda Garner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, University of Melbourne
name: Lisa Phillips, M.Psych, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ORYGEN Research Centre , ORYGEN Youth Health, Department of Psychiatry, University of Melbourne
name: Patrick D McGorry, PhD, FRANZP
role: STUDY_DIRECTOR
References: