| CTRI Number |
CTRI/2023/04/052078 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A research to find out the impact of psychological skill training and motivational counseling on the level of self-confidence, self-control, anxiety and their skills among nursing students in nursing institute in the city. |
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Scientific Title of Study
|
A randomized controlled trial on the effectiveness of Psychological Skills Training and Motivational Counseling on level of self-efficacy, self-regulation, anxiety, and skill performance among nursing students in selected nursing educational institutions in the city. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meena Ganapathy |
| Designation |
Principal cum Professor |
| Affiliation |
Maharshi Karve Stree Shikshan Samsthas Smt. Bakul Tambat Institute of Nursing Education |
| Address |
Maharshi Karve Stree Shikshan Samsthas Smt Bakul Tambat Institute of Nursing education Pune. Principal office, ground floor, nursing department
Maharshi Karve Stree Shikshan Samsthas Smt Bakul Tambat Institute of Nursing Education MKSSS campus Karvenagar Pune, principal office, ground floor, nursing department
Pune
MAHARASHTRA
411052
India |
| Phone |
9860407994 |
| Fax |
02025475020 |
| Email |
meena.ganapathy@mksssbtine.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Laishangbam Bijayalakshmi Devi |
| Designation |
Associate Professor PhD scholar |
| Affiliation |
Maharshi Karve Stree Shikshan SamsthasSmt. Bakul Tambat Institute of Nursing Education |
| Address |
Maharshi Karve Stree Shikshan Samsthas Smt Bakul Tambat Institute of Nursing Education MKSSS campus Karvenagar Pune, Ground floor, First year staff room, First M.Sc.Nursing department.
Maharshi Karve Stree Shikshan Samsthas Smt Bakul Tambat Institute of Nursing Education MKSSS campus Karvenagar Pune. Ground floor, First year staff room, First M.Sc. Nursing department.
Pune
MAHARASHTRA
411052
India |
| Phone |
9225504086 |
| Fax |
02025475020 |
| Email |
bijayalakshmi@mksssbtine.in |
|
Details of Contact Person
Public Query
|
| Name |
Laishangbam Bijayalakshmi Devi |
| Designation |
Associate Professor PhD scholar |
| Affiliation |
Maharshi Karve Stree Shikshan SamsthasSmt. Bakul Tambat Institute of Nursing Education |
| Address |
Maharshi Karve Stree Shikshan Samsthas Smt Bakul Tambat Institute of Nursing Education MKSSS campus Karvenagar Pune
Ground floor, First year staff room, First M.Sc.Nursing department.
Maharshi Karve Stree Shikshan Samsthas Smt Bakul Tambat Institute of Nursing Education MKSSS campus Karvenagar Pune
Ground floor, First year staff room, First M.Sc.Nursing department.
Pune
MAHARASHTRA
411052
India |
| Phone |
9225504086 |
| Fax |
02025475020 |
| Email |
bijayalakshmi@mksssbtine.in |
|
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Source of Monetary or Material Support
|
| The investigator initiated sponsor, Maharshi Karve Stree Shiksan Samsthas Smt. Bakul Tambat Institute of Nursing Education, Karvenagar, Pune
Ground floor first year staff room, First year M.Sc. nursing department.
Pincode- 411052 |
|
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Primary Sponsor
|
| Name |
Laishangbam Bijayalakshmi Devi |
| Address |
MKSSS Smt. Bakul Tambat Institute of Nursing education, Karvenagar, Pune 411052 |
| Type of Sponsor |
Other [The investigator initiated sponsor] |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sripriya GopalKrishnan |
Sadhu Vaswani College of Nursing |
Sadhu Vaswani College of Nursing Sadhu Vaswani Missions Medical Complex 7 9
Principal office, first floor, nursing administrative department. Koregaon Park Pune Maharashtra 411001
Pune
MAHARASHTRA |
02066099960
svcon2006@gmail.com |
| Dr Jyoti Naikare |
Sinhgad College of Nursing, |
Sinhgad College of Nursing, Nursing buiding, Principal office, second floor, administrative block.Sinhgad hospital campus Pune
Maharashtra
Pune
MAHARASHTRA |
02024106142
principal.scon@sinhgad.edu |
| Prof Lt Col Retd Shobha Naidu |
St Andrews College of Nursing |
St Andrews College of Nursing
Principal office, first floor, nursing building, 283 Dinkarrav Javalkar Rd Sathe Colony Shukrawar Peth Pune Maharashtra 411002
Pune
MAHARASHTRA |
02042232591
standrewscon@gmail.com |
| Dr Shrelekha Rajesh |
Tehmi Grant Institute of Nursing Education |
Tehmi Grant Institute of Nursing Education, Vice Principal office, second floor, nursing administrative department
13-Tadiwala Road, Opposite Hotel Meru, Pune-411001, Maharashtra.
Pune
MAHARASHTRA |
02066455688
tgine@rubyhall.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
| Sadhu Vaswani College of Nursing |
No Objection Certificate |
| Sinhgad College of Nursing |
No Objection Certificate |
| St. Andrews College of Nursing |
No Objection Certificate |
| Tehme Grant Institute of Nursing Education |
No Objection Certificate |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overall physically and mentally stable human volunteers free from any acute or chronic health diseases with good eyesight and hearing capacity |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Counseling |
MOTIVATIONAL COUNSELING: Intervention for group B (treatment B)
Motivational counseling session will be conducted by investigator base on motivational interviewing model. It is to be noted that the last phase i.e. implementation phase depart from MI model, hence this motivational counseling differ from MI in this aspect as it include implementation, more directive intervention in the group counseling with inclusion of mindfulness as an active intervention component. This phases will be overlapping or re-initiating as need arise.
The motivational counseling will include a total of 12 offline sessions for 45 minutes in face to face group format with 15 minutes of group activity like mindfulness etc. and daily 20 minutes guided practice on-line session (no on-line session on the day of offline session) in span of 6 weeks of duration in 42 days. A log book will be given to all participants for recording.
1. Engaging phase, in this phase, the counselor in role of facilitator explores perceived positive and negative aspects of change. Open-ended questions are used to elicit participant’s expression, and reflective paraphrase is used to reinforce key points of motivation counseling with specific group activity in 2 offline sessions in a week of 45 minutes and mindfulness activity at the end of each session for 15 minutes, and daily on-line guided mindfulness practice for 20 minutes.
2. Focusing phase, the counselor will explore ambivalent, weighing the pros and cons of change or performance improvement among group members or individually within group with specific group activity in 2 offline sessions in a week of 45 minutes with breath work, and mindfulness activity for 15 minutes, and daily on-line guided mindfulness practice for 20 minutes.
3. Evoking phase, the counselor will facilitate behavioral change among the individuals in the group and as groups dynamic begins and started considering options for changing certain aspect of their life with specific group activity in 2 offline sessions in a week of 45 minutes and mindfulness practice activity for 15 minutes, and daily on-line guided mindfulness practice for 20 minutes.
4. Planning phase, the counselor facilitate group involves in taking specific steps to dwell and plan strategies to accomplish change with specific activity and group assignments like implementation intention, conducted in 2 offline sessions in a week with duration of 45 minutes and mindfulness practice activity for 15 minutes, and daily on-line guided mindfulness practice for 20 minutes.
5. Implementation phase, involves actual action, implementing it using specifics strategies as group members within the group. A vicarious video viewing experience, especially design for blood pressure measuring skill will be shown in this phase for 8 minutes. This phase is plan to achieve in 4 offline sessions in two week with duration of 45 minutes and mindfulness practice for 15 minutes, and daily mindfulness practice for 20 minutes
|
| Intervention |
Psychological Skills Training |
PSYCHOLOGICAL SKILL TRAINING-Intervention for group A (treatment A)
Phases of the Psychological Skills Training (PST) Program: these session will be conducted by the investigator. There will be three phases which are given in brief below. The PST will favor to enhance self-efficacy, self-regulation, and skill performance and at the same time, reduce anxiety.
The psychological skills training will include a total of 12 offline sessions for 45 minutes in face to face group format and daily 20 minutes guided practice online sessions (no online session on the day of offline session) in span of 6 weeks of duration in 42 days.
1. The educational phase: This phase will focus on developing the understanding and importance of Psychological Skill Training The instruction will be given by the investigator. Two offline sessions of 45 minutes for a week in group and daily 20 minutes online guided practice group sessions (except the day of offline session) on goal setting technique. A log book will be given to all participants (semester 1 and or 2 nursing students) for recording.
2. The acquisition phase: This phase focuses on learning the specific methods for acquiring and developing the specified psychological skills as procedural learning process in six offline sessions for 45 minutes duration in span of 3 weeks and daily 20 minutes online guided practice group sessions (except the day of offline session) on psychological skills i.e. goal setting, progressive muscle relaxation, guided imagery and rehearsal and attention training and record the practice daily in log book.
3. The practice phase: In this phase, participants/ subject will be shown a selected vicarious experience in form of video (BP measurement skill) for 8 minutes. It is assume that, subject’s participants are aware of theoretical aspect of what is manual B.P. apparatus operation in novice level. They will practice this selected procedure using the specific PST method taught in span of 2 weeks during 5 sessions of 45 minutes duration and online guided daily practice of 20 minutes.
|
| Comparator Agent |
Standard training in nursing institutes |
Standard training in nursing institutes. participants or nursing students of semester 1 and or 2 who are getting standard usual routine education services routinely provided in the settings from which trial participants are recruited. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Only first-year nursing students (semesters 1 and 2) will be included in the study.
Nursing students between the age groups of 18 years to 35 years of age.
Nursing students who are a healthy individual
Both male and female nursing students will be included in the study.
Nursing students who understand, read and write Hindi, and English language will be included in the study.
Nursing students who have understood, completed, and sign the informed consent voluntarily for the study.
Nursing students who are exposed to the fundamental concept of blood pressure measurement in theory classes and/or in simulation.
Nursing students who have the ability to follow instructions during intervention sessions.
Nursing students who have attended all the intended intervention training protocols of the study.
|
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| ExclusionCriteria |
| Details |
Nursing student who have been diagnosed with acute or chronic medical/mental conditions.
Nursing student who would not be able to understand and follow the intervention session’s instruction training
Nursing students who have already experienced or are sensitized with psychological skill training or motivational interviewing counseling or its form of training previously.
Nursing student who had attended a similar research project.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Intervention A: Difference of 10% improvement in self-efficacy, self-regulation, skill performance score and 10% reduction in anxiety level among nursing students after 6 weeks of intervention of PST (Psychological Skills Training) in post intervention assessment after 2 months and 4 months
Intervention B: Difference of 10% improvement in self-efficacy, self-regulation, skill performance score and 10% reduction in anxiety level among nursing students after 6 weeks of intervention of MC (Motivational Counseling) in post intervention assessment after 2 months and 4 months.
|
Time points 1, Time points 2, time points 3 and time points 4. |
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Secondary Outcome
|
| Outcome |
TimePoints |
Intervention A: Maintaining 10% improvement from baseline data scores more than self-efficacy, self-regulation, skill performance score and 10% reduction in anxiety level among nursing students after 6 weeks of intervention of PST (Psychological Skills Training) in post intervention assessment after 2 months and 4 months
Intervention B: Maintaining 10% improvement from baseline data scores more than self-efficacy, self-regulation, skill performance score and 10% reduction in anxiety level among nursing students after 6 weeks of intervention of MC (Motivational Counseling) in post intervention assessment after 2 months and 4 months.
Qualitative interview finding by memoing interviews during intervention duration, validating the primary outcome through thematic analysis. |
Time point 1, Time point 2,Time points 3 and time points 4 |
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Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
02/05/2023 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This research topic ‘A
randomized controlled trial on the effectiveness of psychological skills
training (PST) and motivational counseling (MC) on the level of self-efficacy,
self-regulation, anxiety, and skill performance among nursing students in
selected nursing educational institutions in the city.-[PST, MC, GSE, GAD-7,
SSRQ] is conducted as a partial fulfillment for Ph.D in nursing under
Maharashtra University of Health Sciences, Nashik.
The investigator
hope to apply the concept of Psychological skills training as part of
mainstream practice among nursing students in the nursing professional and
curious to know its impact of PST on nursing student self-efficacy,
self-regulation, their nursing skill performance and tackle their anxiety
issue. At the same time,the investigator is investigating to know the novel version
of motivational counseling group format style base on MI model in combination
with mindfulness practice, would be another way to enhance nursing student
self-efficacy, self-regulation, their nursing skill performance and help in
tacking their anxiety. Such combination of study has not been conducted among
nursing students in India. Reviews of related Literatures indicated that there
is a gap and indicated the need for such kind of study finding.
|