CTRI Number |
CTRI/2018/02/011902 [Registered on: 13/02/2018] Trial Registered Retrospectively |
Last Modified On: |
09/02/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical trial to study the effect of counseling on Distress Tolerance, Interpersonal Relationship and Mindfulness among nursing students†|
Scientific Title of Study
|
“A Randomized Control Trial to assess the effect of counseling on Distress Tolerance, Interpersonal Relationship and Mindfulness among nursing students†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Dr Usha Ukande |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mrs Blessy Antony |
Designation |
Professor |
Affiliation |
Choithram College of Nursing |
Address |
56 Sai Vihar Colony
Behind Swarna Vatika
Pipliyahana Road
Indore Department of Psychiatric Nursing
Choithram College of Nursing Manik Bagh Road
Indore Madhya Pradesh Indore MADHYA PRADESH 452001 India |
Phone |
07312764009 |
Fax |
07312470068 |
Email |
blessyantony2009@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Mrs Blessy Antony |
Designation |
Professor |
Affiliation |
Choithram College of Nursing |
Address |
56 Sai Vihar Colony
Behind Swarna Vatika
Pipliyahana Road
Indore Department of Psychiatric Nursing
Choithram College of Nursing Manik Bagh Road
Indore Madhya Pradesh Indore MADHYA PRADESH 452001 India |
Phone |
09893510257 |
Fax |
07312470068 |
Email |
blessyantony2009@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Usha Ukande |
Designation |
Principal |
Affiliation |
Choithram College of Nursing |
Address |
Choithram Hospital Campus
Manik Bagh Road
Indore Choithram College of Nursing Manik Bagh Road
Indore Madhya Pradesh Indore MADHYA PRADESH 452014 India |
Phone |
07312764009 |
Fax |
07312470068 |
Email |
usha_mullick@yahoo.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Mrs Blessy Antony |
Address |
Professor, Department of Psychiatric Nursing Choithram College of Nursing Manik Bagh Road Indore Madhya Pradesh. |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Usha Ukande |
Principal
Choithram College of Nursing
Manik Bagh Road
Indore
MP |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Mrs Blessy Antony |
Choithram College of Nursing |
Choithram Hospital And Research Centre
Manik Bagh Road Indore MADHYA PRADESH |
9893510257 07312470068 blessyantony2009@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Choithram Hospital and Research Center |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Level of distress distress tolerance Interpersonal relationship and mindfulness of nursing students |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Counselling |
Mindfulness Interpersonal Effectiveness Skills
Distress Tolerance Skills |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
26.00 Year(s) |
Gender |
Both |
Details |
First year B.Sc. Nursing students of both gender
Above 18 years of age
Students who will score >20 on K10 scale
Students who will give their voluntary written informed consent for participation in the study
|
|
ExclusionCriteria |
Details |
Students who have previous exposure to counseling
Non-compliant with the intervention
Students who will not provide their voluntary written informed consent for participation in the study
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Distress score
Interpersonal Relationship score
Rathus Assertiveness score
Mindfulness score
Assessment of these scores will be done prior to the intervention then a 6 weeks intervention will be given followed by post intervention assessment and then third assessment after 1 year
|
Distress score
Interpersonal Relationship score
Rathus Assertiveness score
Mindfulness score
Assessment of these scores will be done prior to the intervention then a 6 weeks intervention will be given followed by post intervention assessment and then third assessment after 1 year
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="220" Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
06/09/2015 |
Date of Study Completion (India) |
06/02/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="5" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Effect of structured Training Program (STP) to inculcate coping skills among Nursing Students
Stress Management Professional An International Journal Vol3 No. 1 January June 2015
Stress Maladjustment and Coping among Nursing Students A Systematic Review Indian Journal of nursing studies Registered under newspaper act vide no MPENG 2010 36219 ISSN 2229-3280) Vol.5 No.2 July-Dec 2014
Presented Paper on Effect of counseling for distress tolerance, interpersonal relationship and mindfulness among nursing students: A pilot study in Nursing World Conference,
Dubai, UAE, October 27-29,2016
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
It’s a Randomized Parallel
group trial study conducted in India to assess the effectiveness
of counseling on distress tolerance, Interpersonal relation and Mindfulness
among nursing students. This study was conducted in five nursing colleges of
Indore city of the state of Madhya Pradesh. A quantitative research Approach
was adopted in the study. Multi-Stage Random Sampling method was adopted in
this study. Sample allocation was done
using K10 tool. Students from three nursing colleges were assigned to form the experimental group and students from the remaining
two nursing colleges formed the control group. On the basis of Power analysis
sample size was calculated. The instruments used in this study were Socio
demographic data, Kessler Psychological Distress Scale (K10), Distress
Tolerance scale, Interpersonal Competency Questionnaire, Rathus Assertiveness
Scale and Mindfulness Attention Awareness Scale. In the experimental group a
Pretest was conducted at the initial phase and then sessions (intervention)
were conducted for 6 weeks. Post test assessment was done using the same tools
at the end of 6 weeks of intervention. For control group no intervention was
initiated. Only a pretest at initial phase and post test after 6 weeks using
the same set of questionnaires was conducted. Follow up was conducted after 1
year of pretest. Counseling, through eclectic approach was incorporated by
skill training in groups. Analysis done at 6 weeks of intervention showed that there
is a high prevalence of distress among nursing students. If the problem is
addressed at the initial stage itself and with proper training imparted to
nursing students to deal or cope with the problem, they can, not only manage
stress better but can utilize these skills, lifelong.
Hypotheses:
H0: There will be no significant
difference in the level of distress before and after intervention in
experimental group at the level of p<0.05.
H0: There will be no significant
difference in distress tolerance before and after intervention in experimental
group at the level of p<0.05.
H0: There will be no
significant difference in Interpersonal competency before and after
intervention in experimental group at the level of p<0.05.
H0: There will be no
significant difference in level of assertiveness before and after intervention
in experimental group at the level of p<0.05.
H0: There will be no significant
difference in core mindfulness attention awareness score before and after
intervention in experimental group at the level of p<0.05.
H0: There will be no significant
difference in level of distress, distress tolerance level, Interpersonal
competency, assertiveness and core mindfulness attention awareness score between
the experimental group and control group before intervention at the level of p <
0.05.
The
primary outcome measures are Distress level score, distress tolerance score,
Interpersonal Competency score, Assertiveness score and Mindfulness Attention
Awareness score before intervention, after intervention of 6 weeks and at the
end of 1 year from preintervention. |