NCT00421070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

January 10, 2007

Last Update Submit

April 26, 2015

Conditions

Keywords

AggressionMassageStressPsychiatric inpatient

Outcome Measures

Primary Outcomes (5)

  • Aggression

    6 weeks

  • Irritability

    6 weeks

  • Anxiety

    6 weeks

  • Depression

    6 weeks

  • Cortisol levels

    6 weeks

Secondary Outcomes (4)

  • Psychosocial climate

    6 weeks

  • PRN medication

    6 weeks

  • Incidence of seclusion or restraint

    6 weeks

  • Duration of hospitalisation

    6 weeks

Study Arms (2)

Treatment as usual

NO INTERVENTION

Observational component

Intervention

ACTIVE COMPARATOR

Massage therapy adjunct comparator

Procedure: Massage therapy

Interventions

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.

Intervention

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Admission to the ORYGEN Inpatient Unit

You may not qualify if:

  • Highly agitated and aggressive patients remaining in a severely aggressive state for more than 24 hours after admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ORYGEN Youth Health

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Mood DisordersAggression

Interventions

Massage

Condition Hierarchy (Ancestors)

Mental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Belinda Garner, PhD

    ORYGEN Research Centre, Department of Psychiatry, University of Melbourne

    PRINCIPAL INVESTIGATOR
  • Lisa Phillips, M.Psych, PhD

    Department of Psychology, University of Melbourne

    PRINCIPAL INVESTIGATOR
  • Patrick D McGorry, PhD, FRANZP

    ORYGEN Research Centre , ORYGEN Youth Health, Department of Psychiatry, University of Melbourne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

May 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations