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CTRI Number  CTRI/2026/03/106665 [Registered on: 20/03/2026] Trial Registered Prospectively
Last Modified On: 20/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [skill enhancement training]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of skill enhancement training on selected parameters of deaddiction care by nurses working at tertiary care hospital 
Scientific Title of Study   A randomized controlled trial to evaluate the effectiveness of skill enhancement training on selected parameters of deaddiction care by nurses working in de-addiction centre at selected tertiary care hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PRIYANKA MALHOTRA 
Designation  Nursing Tutor 
Affiliation  AIIMS, RISHIKESH , INDIA 
Address  College of Nursing, Buiding number-45, AIIIMS Rishikesh, Dehradun, India
College of Nursing, Buiding number-45, AIIIMS Rishikesh, Dehradun, India.P Code- 249203
Dehradun
UTTARANCHAL
249203
India 
Phone  07310688038  
Fax    
Email  priyankamalhotraaiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PRIYANKA MALHOTRA 
Designation  Nursing Tutor 
Affiliation  AIIMS, RISHIKESH , INDIA 
Address  College of Nursing, Buiding number-45, AIIIMS Rishikesh, Dehradun, India
College of Nursing, Buiding number-45, AIIIMS Rishikesh, Pin: 249203Dehradun, India
Dehradun
UTTARANCHAL
249203
India 
Phone  07310688038  
Fax    
Email  priyankamalhotraaiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR. RAJESH KUMAR 
Designation  Associate Professor  
Affiliation  AIIMS, RISHIKESH , INDIA 
Address  College of Nursing, Buiding number-45, AIIIMS Rishikesh, Dehradun, India
College of Nursing, Buiding number-45, AIIIMS Rishikesh,Pin- 249203 Dehradun, India
Dehradun
UTTARANCHAL
249203
India 
Phone  7055911523  
Fax    
Email  rajesh.nur@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
AIIMS Rishikesh 
 
Primary Sponsor  
Name  PRIYANKA MALHOTRA 
Address  College of Nursing, Buiding number-45, AIIIMS Rishikesh, Dehradun, India.PIN- 249203 
Type of Sponsor  Other [SELF FUNDED] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
PRIYANKA MALHOTRA  AIIMS RISHIKESH   LECTURE THEATRE, Room No. 1,AIIMS RISHIKESH, VEERBHADRA ROAD, RISHIKESH, DEHRADUN
Dehradun
UTTARANCHAL 		 07310688038

priyankamalhotraaiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITTE,AIIMS RISHIKESHE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health care professionals from nursing department  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine care   need based routine nursing care as currently practiced in their clinical settings 
Intervention  Skill Enhancement Training (SET)   The proposed intervention, a structured ‘skill enhancement training’ will be developed through an extensive review of existing literature, the researcher’s professional insights, experts opinion and discussions with frontline healthcare professionals. The training will be designed to strengthen nurses clinical decision making , self efficacy, professionalism by enhancing their knowledge and communication skills in deaddiction care by nurses involve in direct care of patients with substance use disorders and/or addictive behavioral disorders. The training will be structured into two key parts:- a) knowledge enhancement, b) communication skills. Intervention will be conducted for approx. two hours.  
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Nurses working on a rotation basis in deaddiction center for at least 6 months.
Nurses involved in direct patient care.
Nurses willing to participate in the study & provide consent.
 
 
ExclusionCriteria 
Details  Nurses diagnosed with chronic physical and mental issues and under treatment for the same.
Nurses unavailable at the setting due to one of the following reasons i.e. maternity leave, sick leave, or any other long leave 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
effectiveness of skill enhancement training on selected parameters of deaddiction care ( primary outcome used in sample size calculation and main outcome to determine effect of intervention)  7 day and 15 day 
 
Secondary Outcome  
Outcome  TimePoints 
association of selected parameters of deaddiction care with selected demographic variables of nurses  7 day and 15 day 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   12/06/2026 
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="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyankamalhotraaiims@gmail.com].

  6. For how long will this data be available start date provided 02-01-2029 and end date provided 02-01-2034?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
•The skill enhancement  training is designed to cultivate professionalism, strengthen clinical decision-making, and boost self-efficacy by enhancing both knowledge and communication skills  among nurses in deaddiction care.
•The administration can mandate that this training will be a part of capacity-building initiative, targeting employed nurses across all departments to deliver high-quality de-addiction care at tertiary care institutions.
Even though addiction psychiatry has been introduced as an elective module in the B.Sc. Nursing curriculum, in accordance with Indian Nursing Council (INC) guidelines, there remains substantial scope for its elevation as a super-specialty area within postgraduate programs in mental health nursing. 
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