| CTRI Number |
CTRI/2024/11/077410 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Counselling |
|
Scientific Title of Study
|
Effectiveness of Counselling on Low Academic Performers among Nursing Students in Nagaland |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bendangmenla Ao |
| Designation |
Professor |
| Affiliation |
CIHSR,Christian Institute of Health Sciences and Research |
| Address |
College of Nursing (CIHSR)
Christian Institute of health Sciences and Research. Diphupar 4th mile . Chumoukedima Nagaland
Dimapur NAGALAND 797115 India |
| Phone |
|
| Fax |
|
| Email |
amenlapongen@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Glenn C Kharkongor |
| Designation |
Professor of Public Health |
| Affiliation |
MLCU (Martin Luther Christian University) |
| Address |
MLCU(Martin Luther Christian University). Dongktieh Block-1 Nongrah, Shillong.
Meghalaya
East Khasi Hills MEGHALAYA 793006 India |
| Phone |
9862047585 |
| Fax |
|
| Email |
glenchristo@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Glenn C Kharkongor |
| Designation |
Professor of Public Health |
| Affiliation |
MLCU (Martin Luther Christian University) |
| Address |
MLCU . Martin Luther Christian University. Dongktieh Block-1 Nongrah Campus, Shillong.
Meghalaya
East Khasi Hills MEGHALAYA 793006 India |
| Phone |
9862047585 |
| Fax |
|
| Email |
glenchristo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| COLLEGE OF NURSING, CIHSR (Christian Institute of Health Sciences and Research. 4th Mile Diphupar. Near Central Jail Road.Chumoukedima .Dimapur Nagaland. India 797115 |
|
|
Primary Sponsor
|
| Name |
Bendangmenla Ao |
| Address |
CIHSR, Dimapur Nagaland. 4th mile Diphupar. Chumoukedima. Dimapur Nagaland India 797115 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Bendangmenla Ao |
CIHSR-Christian Institute of Health Sciences and Research |
Department, College of Nursing, CIHSR, 4th Mile Diphupar Dimapur - Nagaland India 797115 Dimapur NAGALAND |
8413004537
amenlapongen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CIHSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Student group |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Counselling for Low academic performers |
remedial coaching, retesting, and Mentoring, along with Counselling for 6-9 months |
| Comparator Agent |
Standard remedial coaching, retest and mentoring for 6-9 months |
No intervention for control group by the investigator |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. All the 2nd and 3rd year of GNM & BSC Nursing students
2. Students who scored less than 50 percent on average in a given academic year
3. Those who are willing to give consent and participate in the research
|
|
| ExclusionCriteria |
| Details |
1. 1st-year are excluded since they have not appeared for the pre-university examination in the college at the time of data collection.
2. Post-basic students and 4th year Bsc Nursing Students are excluded to maintain the homogeneity of the sample participants
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To identify the low performers and the factors related to low academic performance
2. To develop a counselling model for low-performing students
3. To determine the effectiveness of counselling among low academic performers
|
6-9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To develop a standard tool for assessing low academic performers |
6-9 months |
|
|
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)
|
06/01/2025 |
| 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="7" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized control trial to determine the effectiveness of counseling for low academic performers among Nursing Students in Nagaland, North-East India. The Control group will receive standard care, such as remedial coaching, retests, and mentoring by the subject teachers. The experimental group will receive standard care along with Counselling by the principal investigator. The primary objective is to identify factors responsible for low academic performance and the effectiveness of counseling based on the factors identified. The secondary objective is to develop a counseling scheme or module for low performers. The final outcome will be an improvement in their scores at the end of their final assessment. |