| CTRI Number |
CTRI/2018/06/014490 [Registered on: 11/06/2018] Trial Registered Prospectively |
| Last Modified On: |
30/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of “brief intervention package" on aggression and violent behaviour of person with mental illness . |
|
Scientific Title of Study
|
A pre experimental study to assess the effectiveness of “brief intervention package on aggression and violent behaviour†for nurses and caregivers to reduce aggressive and violent episodes of person with mental illness(PMI) in psychiatric units, PGIMER, Chandigarh,2017-19. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nibedita Banerjee |
| Designation |
M.Sc Nursing Student |
| Affiliation |
Affiliated by National Institute Of Nursing Education,PGIMER,Chandigarh |
| Address |
National Institute Of Nursing Education,Sector-12, PGIMER, Chandigarh Pin-160012
NINE,PGIMER,SECTOR 12,CHANDIGARH
PIN 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9093645540 |
| Fax |
|
| Email |
banerjeenibedita94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSandhya Ghai |
| Designation |
Principal, Nine, PGIMER, Chandigarh |
| Affiliation |
Affiliated by National Institute Of Nursing Education,PGIMER,Chandigarh |
| Address |
National Institute Of Nursing Education,Sector-12, PGIMER, Chandigarh Pin-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9780680616 |
| Fax |
|
| Email |
Sandhya.ghai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nibedita Banerjee |
| Designation |
M.Sc Nursing Student |
| Affiliation |
Affiliated by National Institute Of Nursing Education,PGIMER,Chandigarh |
| Address |
National Institute Of Nursing Education,Sector-12, PGIMER, Chandigarh Pin-160012
NINE,PGIMER,Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9093645540 |
| Fax |
|
| Email |
banerjeenibedita94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nibedita Banerjee |
| Address |
National Institute Of Nursing Education, Sector-12, PGIMER,Chandigarh, 160012 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nibedita Banerjee |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Department of psychiatry, Inpatient and OPD, Nehru building, PGIMER, sector-12, chandigarh, 160012
Chandigarh
CHANDIGARH |
9093645540
banerjeenibedita94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses and caregivers of patients of psychiatry department, PGIMER, Chandigarh |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief intervention package on aggression and violent behaviour |
Information booklet on management of aggression and violence behavior for nurses and caregivers. |
| Comparator Agent |
Routine care and attitude of nurses and caregivers. |
Routine care and attitude towards violent behaviour of psychiatric patients by nurses and caregivers |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Nurses available in study period.
2. Caregivers of person who pose a high risk towards self or others.
|
|
| ExclusionCriteria |
| Details |
1. Caregivers who are having some psychotic disorders previously. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce Frequency, duration and severity of aggression and violent behavior of Persons with mental illness. |
1 week after giving brief intervention package. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check incidence of aggression and violent behaviour of patients with psychiatric illness |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A pre experimental study to assess the effectiveness of “brief intervention package on aggression and violent behaviour†for nurses and caregivers to reduce aggressive and violent episodes among persons with mental illness (PMI) in psychiatric units, PGIMER, Chandigarh, 2017-18 OBJECTIVES 1.To assess episodes of aggressive and violent behaviour of persons with mental illness in psychiatric unit, Nehru hospital, PGIMER ,Chandigarh. 2.To develop and implement “brief intervention package on aggression and violent behaviour†for nurses and caregivers of persons with mental illness in psychiatric unit, Nehru hospital PGIMER, Chandigarh. HYPOTHESIS — Null Hypothesis- There is no significant effect of brief intervention package on episodes of aggression and violent behaviour at < 0.05 level of significance. — Research Hypothesis- There is significant effect of brief intervention package on episodes of aggression and violent behaviour < 0.05 level of significance.
|