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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00421070
Other study ID # HREC2005.060
Secondary ID
Status Completed
Phase N/A
First received January 10, 2007
Last updated April 26, 2015
Start date May 2006
Est. completion date September 2006

Study information

Verified date April 2015
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 25 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Australia ORYGEN Youth Health Melbourne Victoria

Sponsors (2)

Lead Sponsor Collaborator
Melbourne Health National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aggression 6 weeks No
Primary Irritability 6 weeks No
Primary Anxiety 6 weeks No
Primary Depression 6 weeks No
Primary Cortisol levels 6 weeks No
Secondary Psychosocial climate 6 weeks No
Secondary PRN medication 6 weeks No
Secondary Incidence of seclusion or restraint 6 weeks No
Secondary Duration of hospitalisation 6 weeks No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05863637 - Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting N/A