Psychiatric &or Mood DisorderNCT00421070
Effect of Massage Therapy on Aggression in a Psychiatric Inpatient Unit
A study testing Massage therapy in people with Psychiatric &or Mood Disorder, run by Melbourne Health at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Psychiatric &or Mood Disorder
- What is being tested?
- Massage therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteAustralia
- Study dates
- May 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Admission to the ORYGEN Inpatient Unit
Who cannot join
- Highly agitated and aggressive patients remaining in a severely aggressive state for more than 24 hours after admission
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Psychiatric &or Mood Disorder
- Being tested
- Massage therapy
- Keywords
- Aggression, Massage, Stress, Psychiatric inpatient
- Medical subject headings
- Mood Disorders, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Observational component |
| Intervention | Active comparator | Massage therapy adjunct comparator Receives: Procedure: Massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggression
Measured: 6 weeks
Irritability
Measured: 6 weeks
Anxiety
Measured: 6 weeks
Depression
Measured: 6 weeks
Cortisol levels
Measured: 6 weeks
Secondary outcomes (4)
Psychosocial climate
Measured: 6 weeks
PRN medication
Measured: 6 weeks
Incidence of seclusion or restraint
Measured: 6 weeks
Duration of hospitalisation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startMay 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric &or Mood DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Belinda Garner, PhD, Principal investigator, ORYGEN Research Centre, Department of Psychiatry, University of MelbourneLisa Phillips, M.Psych, PhD, Principal investigator, Department of Psychology, University of MelbournePatrick D McGorry, PhD, FRANZP, Study director, ORYGEN Research Centre , ORYGEN Youth Health, Department of Psychiatry, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421070
- Sponsor's protocol ID
- HREC2005.060
- Status last verified
- Apr 2015
- First submitted
- 10 Jan 2007
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00421070
- Acronym / sponsor ID
- HREC2005.060
- Conditions
- Psychiatric &or Mood Disorder
- Keywords
- Aggression, Massage, Stress, Psychiatric inpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- May 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Observational component |
| Intervention | Active comparator | Procedure: Massage therapyMassage therapy adjunct comparator |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Admission to the ORYGEN Inpatient Unit
Key exclusion criteria (1 listed)
- Highly agitated and aggressive patients remaining in a severely aggressive state for more than 24 hours after admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage therapyA 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. | Procedure or surgery | Intervention |
Primary outcome
Aggression
Time frame: 6 weeks
Irritability
Time frame: 6 weeks
Anxiety
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Cortisol levels
Time frame: 6 weeks
4 secondary outcomes
Psychosocial climate
Time frame: 6 weeks
PRN medication
Time frame: 6 weeks
Incidence of seclusion or restraint
Time frame: 6 weeks
Duration of hospitalisation
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda Garner, PhD principal investigator
ORYGEN Research Centre, Department of Psychiatry, University of Melbourne
Lisa Phillips, M.Psych, PhD principal investigator
Department of Psychology, University of Melbourne
Patrick D McGorry, PhD, FRANZP study director
ORYGEN Research Centre , ORYGEN Youth Health, Department of Psychiatry, University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy in people with Psychiatric &or Mood Disorder, run by Melbourne Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggression (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.