Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit
Primary Purpose
Psychiatric &or Mood Disorder
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Massage therapy
Sponsored by
About this trial
This is an interventional treatment trial for Psychiatric &or Mood Disorder focused on measuring Aggression, Massage, Stress, Psychiatric inpatient
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
Sites / Locations
- ORYGEN Youth Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Treatment as usual
Intervention
Arm Description
Observational component
Massage therapy adjunct comparator
Outcomes
Primary Outcome Measures
Aggression
Irritability
Anxiety
Depression
Cortisol levels
Secondary Outcome Measures
Psychosocial climate
PRN medication
Incidence of seclusion or restraint
Duration of hospitalisation
Full Information
NCT ID
NCT00421070
First Posted
January 10, 2007
Last Updated
April 26, 2015
Sponsor
Melbourne Health
Collaborators
National Health and Medical Research Council, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00421070
Brief Title
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health
Collaborators
National Health and Medical Research Council, Australia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric &or Mood Disorder
Keywords
Aggression, Massage, Stress, Psychiatric inpatient
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Observational component
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Massage therapy adjunct comparator
Intervention Type
Procedure
Intervention Name(s)
Massage therapy
Intervention Description
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 Measure Information:
Title
Aggression
Time Frame
6 weeks
Title
Irritability
Time Frame
6 weeks
Title
Anxiety
Time Frame
6 weeks
Title
Depression
Time Frame
6 weeks
Title
Cortisol levels
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Psychosocial climate
Time Frame
6 weeks
Title
PRN medication
Time Frame
6 weeks
Title
Incidence of seclusion or restraint
Time Frame
6 weeks
Title
Duration of hospitalisation
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belinda Garner, PhD
Organizational Affiliation
ORYGEN Research Centre, Department of Psychiatry, University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Phillips, M.Psych, PhD
Organizational Affiliation
Department of Psychology, University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick D McGorry, PhD, FRANZP
Organizational Affiliation
ORYGEN Research Centre , ORYGEN Youth Health, Department of Psychiatry, University of Melbourne
Official's Role
Study Director
Facility Information:
Facility Name
ORYGEN Youth Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
12. IPD Sharing Statement
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Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit
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