| CTRI Number |
CTRI/2023/01/049225 [Registered on: 25/01/2023] Trial Registered Prospectively |
| Last Modified On: |
25/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Quasi Experimental Study Educational intervention on SPEM Program by the researcher for nurses] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Selected Psychiatric Emergency Management (SPEM) Programme upon the Competency among Nurses. |
|
Scientific Title of Study
|
A Quasi Experimental Study to Assess the Effectiveness of Selected Psychiatric Emergency Management (SPEM) Programme upon the Competency in Managing the Psychiatric Emergencies among Nurses at Selected Hospitals, Chennai. |
| Trial Acronym |
SPEM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANURADHA C |
| Designation |
Professor |
| Affiliation |
Apollo College of Nursing |
| Address |
ANURADHA C, Professor, Psychiatric Nursing Department, Room no.39, Apollo College of Nursing, Ayanambakkam, Vanagaram to Ambattur Main Road, Chennai-600095.
TAMIL NADU
India
Apollo College of Nursing
AYANAMBAKKAM
CHENNAI 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9710947288 |
| Fax |
|
| Email |
anuradhachandran2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANURADHA C |
| Designation |
Professor |
| Affiliation |
Apollo College of Nursing |
| Address |
ANURADHA C, Professor, Psychiatric Nursing Department, Room no.39, Apollo College of Nursing, Ayanambakkam, Vanagaram to Ambattur Main Road, Chennai-600095.
TAMIL NADU
India
Apollo College of Nursing
AYANAMBAKKAM
CHENNAI 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9710947288 |
| Fax |
|
| Email |
anuradhachandran2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K VIJAYALAKSHMI |
| Designation |
Professor |
| Affiliation |
Apollo College of Nursing |
| Address |
Dr K VIJAYALAKSHMI, Professor, Psychiatric Nursing Department, Room no.39(cabin), Apollo College of Nursing, Ayanambakkam, Vanagaram to Ambattur Main Road, Chennai-600095.
TAMIL NADU
India.
Apollo College of Nursing
AYANAMBAKKAM
CHENNAI 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9150111120 |
| Fax |
|
| Email |
k.vijayalakshmi2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals, Greams road, Chennai. |
| Apollo Specialty Hospitals, Vanagaram, Chennai. |
|
|
Primary Sponsor
|
| Name |
ANURADHA C |
| Address |
Apollo College of Nursing, Ayanambakkam, Vanagaram to Ambattur Main Road, Chennai-95 |
| Type of Sponsor |
Other [Self as Ph.D Research scholar] |
|
|
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 |
| ANURADHA C |
Apollo College of Nursing, Apollo Hospitals,Chennai |
Apollo College of Nursing, Vanagaram to Ambattur Main Road, Ayanambakkam, Chennai-600095.
Chennai
TAMIL NADU |
9710947288
anuradhachandran2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Apollo College of Nursing |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses are study participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Selected Psychiatric Emergency Management (SPEM) Programme. |
Selected Psychiatric Emergency Management (SPEM) Programme:
It is a educational module designed by the researcher using techniques such as lectures, demonstrations and simulation learning programmes for empowering the nurse’s competency in managing the psychiatric emergency conditions such as patients with suicide attempt, delirium and aggression in hospitals. So that it will help to enhance the nurses competency especially in assessment areas including the risk assessment of selected psychiatric emergencies for actual and potential patients admitted in hospitals. This programme will be conducted for 8 hours in one week on every alternative day (2 hours/day) as per the convenience of the hospital and nursing authorities. Ice breaking sessions will be conducted to prevent the monotony of the programme. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Nurses who are available at the time of data collection.
2.Nurses working in inpatient units such as critical care units, post-operative wards, cardio thoracic ICUs, emergency units, neuro, medical and surgical wards in the selected hospitals.
|
|
| ExclusionCriteria |
| Details |
1.Nurses with qualification of M.Sc(N) in Psychiatric nursing specialty.
2.Nurses who had training on Psychiatric Emergencies Management (SPEM) Program within last three years.
3.Nurses who are working in the out Patient Department, operation theatre, endoscopic procedures and catheterization labs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To assess the effectiveness of Selected Psychiatric Emergency Management (SPEM) Programme upon the competency in managing the Psychiatric Emergencies among nurses by comparing the pre and posttests scores in experiment and control group. |
1.Post test I will be conducted 1 week after intervention.
2.Post test II will be conducted 4 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Correlation between knowledge, confidence and skills of nurses
2.Association between selected background variables and competency of nurses |
1.Post test I will be conducted 1 week after intervention.
2.Post test II will be conducted 4 weeks after intervention |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
30/01/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Statement of the Problem A Quasi Experimental Study to Assess the Effectiveness of Selected Psychiatric Emergency Management (SPEM) Programme upon the Competency in Managing the Psychiatric Emergencies among Nurses at Selected Hospitals, Chennai.
Objectives Primary Objectives 1. To assess the level of competency in managing the Psychiatric Emergencies by the nurses before and after the Selected Psychiatric Emergency Management (SPEM) Programme in experiment and control group. 2. . To assess the effectiveness of Selected Psychiatric Emergency Management (SPEM) Programme upon the competency in managing the Psychiatric Emergencies among nurses by comparing the pre and posttests scores in experiment and control group. Secondary Objectives 3. To find out the correlation between knowledge, confidence and skills of nurses in managing the Psychiatric Emergencies in experiment and control group. 4. To find out the association between selected background variables and competency managing the Psychiatric Emergencies among nurses in experiment and control group. 5. To determine the level of acceptability among experimental group of nurses regarding the Selected Psychiatric Emergency Management (SPEM) Programme.
Research Hypotheses H1: There will be a significant difference in competency between control and experimental group of nurses before and after Selected Psychiatric Emergency Management (SPEM) Programme. H2: There will be a significant association between selected background variables and level of competency in control and experimental group of nurses before and after Selected Psychiatric Emergency Management (SPEM) Programme. H3: There will be a significant correlation between posttest level of knowledge, confidence and skills in managing the Psychiatric Emergencies in experiment and control group of nurses.
Operational Definitions
Effectiveness It is the result of Selected Psychiatric Emergency Management (SPEM) programme on improving the competency of nurses working in hospitals as evidenced by increased post test scores measured by comparing the competency scores of nurses before and after administration of Selected Psychiatric Emergency Management (SPEM) Programme. Selected Psychiatric Emergency Management (SPEM) ProgrammeIt is a module designed using techniques such as lectures, demonstrations and simulation learning programmes for empowering the nurse’s competency in managing the psychiatric emergency conditions such as patients with suicide attempt, delirium and aggression in hospitals. So that it will help to enhance the nurses competency especially in assessment areas including the risk assessment of selected psychiatric emergencies for actual and potential patients admitted in hospitals. This programme will be conducted for 8 hours in one week on every alternative day (2 hours/day) as per the convenience of the hospital and nursing authorities. Ice breaking sessions will be conducted to prevent the monotony of the programme. Competency It refers to the capacity / ability of nurses working in hospitals, which includes the knowledge, confidence and skills on Selected Psychiatric Emergency Management (SPEM). Knowledge: It is the awareness and understanding about Selected Psychiatric Emergency Management among nurses as measured by structured knowledge questionnaire on Selected Psychiatric Emergency Management developed by the investigator. Confidence: It refers to feeling of nurses about trusting in own abilities of self-power and judgement in managing the psychiatric emergencies as measured by using rating scale on confidence tool developed by investigator for Selected Psychiatric Emergency Management (SPEM) Programme. Skills: It is the ability of nurses to perform the Selected Psychiatric Emergency Management as measured by using Objective Structured Clinical Examination (OSCE) skill stations, with observational checklists developed by the investigator for Selected Psychiatric Emergency Management (SPEM) Programme.Psychiatric EmergenciesIt refers to Selected Psychiatric Emergencies such as suicide attempt, delirium and aggression. NursesIt refers to the registered staff nurses with qualification of GNM, B.Sc.(N), P.B.B.Sc(N) and M.Sc (N) working in selected hospitals in Chennai. Hospitals It refers to the selected multi-specialty tertiary care hospitals in Chennai.
Research Methodology Research approach Evaluative approach Research Design Quasi Experimental –research design O1 - O2 - O3 O1 X O2 - O3 Variables
Independent Variable: Selected Psychiatric Emergency Management (SPEM) Programme.
Dependent Variables: Competency (knowledge, confidence and skills) of nurses. Research Setting Two Apollo Hospitals will be selected based on feasibility and accessibility of samples (Nurses). Among two hospitals, 1 will be assigned to control group and 1 will be assigned to experimental group randomly which includes: 1. Apollo Specialty Hospitals, Vanagaram, Chennai. 2. Apollo Hospitals, Greams road, Chennai. PopulationTarget PopulationStaff Nurses working in hospitals who satisfy the inclusion criteria. Accessible PopulationThe accessible population in the study will be the staff nurses working in selected hospitals in Chennai. SampleSample includes nurses working in selected hospitals who meet the inclusion criteria. Sample SizeSample size is estimated based on the previous study findings using power analysis. Two hundred and twenty samples (110 in control group and 110 in experimental group) will be included in the study. Sampling Technique From each wards of selected hospitals, the control and experimental group of nurses will be allotted proportionately by using simple random technique as per inclusion criteria.Sampling Criteria Inclusion criteria:
1.Nurses who are available at the time of data collection. 2.Nurses working in inpatient units such as critical care units, post-operative wards, cardio thoracic ICUs, emergency units, neuro, medical and surgical wards in the selected hospitals.
Exclusion criteria: 1.Nurses with qualification of M.Sc(N) in Psychiatric nursing specialty. 2.Nurses who had training on Psychiatric Emergencies Management (SPEM) Program within last three years. 3.Nurses who are working in the out Patient Department, operation theatre, endoscopic procedures and catheterization labs.
Development and Description of Tools 1. Background Variables Proforma to assess the Background Characteristics of nurses. 2. Structured questionnaire to assess the knowledge of nurses in managing the selected psychiatric emergencies. 3. Rating scale to assess the confidence of nurses in managing the Selected Psychiatric Emergencies Management 4. OSCE skills stations with observational checklists to assess the level of skills of nurses in managing the selected psychiatric emergencies. 5. Rating scale to assess the level of acceptability of nurses regarding the Selected Psychiatric Emergency Management (SPEM) Programme.
Pilot Study Pilot study will be conducted with 10% of the total population Permission will be obtained from the concerned authorities. Pilot study will be conducted using the same tools and procedures planned for the main study. Data Collection Data on knowledge and confidence will be collected using predetermined, validated and pretested tools through self administration method and data on skills of nurses will be collected by Objective Structured Clinical Examination (OSCE) skill stations with observational checklists with help from trained simulated patients and trained evaluators. Intervention- SPEM programme will be administered to the experimental group of nurses and control group will receive only their continuing education program done on the job in their hospital. First post test will be conducted after 1 week after intervention and post test 2 will be conducted after 1 month of SPEM programme. Data Analyses Descriptive statistics The descriptive statistical analysis includes frequencies, percentages, means and Standard deviation. Inferential statistics Inferential statistics measured like independent "T’ tests, Pearson correlation coefficient and Repeated measures ANOVA with Post Hoc Analysis will be used to test the hypotheses. The chi-square test will be used to find the association between the background characteristics of nurses.
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