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CTRI Number  CTRI/2025/10/096358 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 28/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Quality improvement study of nurses notes structured training programme on nursing officers]  
Study Design  Other 
Public Title of Study   Improving the quality of nursing documentation in hospital wards in Andhra Pradesh 
Scientific Title of Study   A quality improvement study to improve the nursing documentation in selected wards in a tertiary care hospital Andhra Pradesh 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreya Biswas 
Designation  M.Sc Nursing  
Affiliation  College of nursing AIIMS Mangalagiri 
Address  Room No 002 , Ground Floor PG girls hostel, College of Nursing AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  7001922978  
Fax    
Email  m05024002@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Mr Sharun NV 
Designation  Associate professor 
Affiliation  AIIMS Mangalagiri 
Address  Room No 413, College of Nursing, AIIMS Mangalagiri, Guntur

Guntur
ANDHRA PRADESH
522503
India 
Phone  9406433571  
Fax    
Email  sharun@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query  
Name  Mr Sharun NV 
Designation  Associate professor 
Affiliation  AIIMS Mangalagiri 
Address  Room No 413, College of Nursing, AIIMS Mangalagiri, Guntur


ANDHRA PRADESH
522503
India 
Phone  9406433571  
Fax    
Email  sharun@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
AIIMS Mangalagiri,Guntur, Andhra Pradesh , India. Pin code:-522503 
 
Primary Sponsor  
Name  Shreya Biswas 
Address  Room no 103, College of Nursing AIIMS Mangalagiri 
Type of Sponsor  Other [self funding ] 
 
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 
Dr Yellisetty Ramya Jyothi  AIIMS ,Mangalagiri, Guntur ,Andhra Pradesh Pin 522503  Room No 4078,Ward D4 and B4 (General Surgery Wards) AIIMS Mangalagiri
Guntur
ANDHRA PRADESH 		 9560149232

drramyajyothi@aiimsmangalagiri.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Mangalagiri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nuses of selected wards with at least 3 months of experience in the selected wards, Nurses who consent to participate in the study, Nurses who are proficient in the primary language english 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal routine process of nursing notes  In the comparator group there will be no intervention as the form of nursing documentation training program will not be there , they will continue routine process of nurses note writting without any change 
Intervention  Structured nursing documentation teaching programme   In the intervention group that is selected ward of D4 all the nursing officers working in that ward will receive this intervention. In this intervention total 5 sessions are there in the intervention total 1hour each session consists off 10-15 min approx for each session.First session is Introduction to Nursing Documentation, second Components of Effective Nurses’ Notes ,third session Common Barriers and Solutions ,fourth session Practical Skills Workshop , fifth session Implementing Changes and Follow-Up. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Nurses working in the selected general surgery ward of tertiary care hospital is included in the study.
2) Nurses with at least 3 months of experience in the selected wards, as they will have a sufficient understanding of the current documenta on practices and hospital protocols.
3) Nurses who consent to participate in the study, after understanding the research objectives and procedures are included.
4) Nurses who are proficient in the primary language used for documentation (English) is included.
 
 
ExclusionCriteria 
Details  1)Nurses who are on long-term leave (e.g., maternity leave, sick leave etc.) during the study period will be excluded.
2)Nurses who do not engage directly in patient care or documentation (eg Administrative roles) will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Quality of nursing documentation will be improved in terms of accuracy, completeness , timeliness & compliance   2-3 weeks post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="444"
Sample Size from India="444" 
Final Enrollment numbers achieved (Total)= "444"
Final Enrollment numbers achieved (India)="444" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) 14/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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)  		 It is a quality improvement study to improve the quality of nursing documentation(nurses notes) in selected wards of a tertiary care hospital. Here after taking formal permission from MS and CNO the study will be conducted in D4 ward as intervention group and B4 ward as control group, total 222 sample (nurses notes) in each group will be taken and randomly audit of nurses notes from MRD will be done with the pre made self structured expert validated checklist. Then self structured expert validated barrier assessment questionnaire will be administered to all the nurses working on that selected wards as per convenience. Then structured nursing documentation training programme as intervention will be given to D4 ward nursing officers (total 1hour ,consists of five sessions) and keep only baseline assessment record for control group without any intervention. After the washout period (1 week) again nursing documentation audit will be conducted for both intervention and control group in those selected wards. Data will be collected and analysis will be drawn.  
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