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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  
Mrs Blessy Antony 
 
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  
Status 
Not Applicable 
 
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. 
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