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CTRI Number  CTRI/2025/11/096755 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Preoperative education and post operative outcome]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effectiveness of educational intervention on pain and anxiety among fracture surgery patients. 
Scientific Title of Study   Effectiveness of pre-operative education on anxiety, pain and clinical outcome among adult patients with lower limb fracture undergoing surgery in a selected tertiary care hospital of udupi district, karnataka. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonyog Maity 
Designation  M.Sc. Nursing  
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education ,Manipal 
Address  4th floor, Door No.400A,Manipal College of Nursing, Manipal Academy Of Higher Education ,Manipal ,Udupi, Karnataka ,576104,India

Udupi
KARNATAKA
576104
India 
Phone  7001172565  
Fax    
Email  sonyog.mconmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Janet Prameela DSouza 
Designation  Assistant Professor Senior Scale 
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education ,Manipal 
Address  1st Floor, Manipal College of Nursing, Manipal Academy Of Higher Education ,Manipal ,Udupi, Karnataka ,576104,India

Udupi
KARNATAKA
576104
India 
Phone  9986417306  
Fax    
Email  janet.p@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Janet Prameela DSouza 
Designation  Assistant Professor Senior Scale 
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education ,Manipal 
Address  1st Floor, Manipal College of Nursing, Manipal Academy Of Higher Education ,Manipal ,Udupi, Karnataka ,576104,India

Udupi
KARNATAKA
576104
India 
Phone  9986417306  
Fax    
Email  janet.p@manipal.edu  
 
Source of Monetary or Material Support  
Katurba Hospital,Manipal,Manipal Academy of Higher Education,Karnataka,India,576104 
 
Primary Sponsor  
Name  Sonyog Maity 
Address  4th floor, Door No.400A,Manipal College of Nursing, Madhav Nagar, Manipal Academy Of Higher Education ,Manipal ,Udupi, Karnataka ,576104,India 
Type of Sponsor  Other [Self funded (no external sponsor)] 
 
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 Raghuraj Kundangar  Kasturba Hospital, Manipal  1st floor and 2nd floor orthopedics wards- (OM1,OM2,OF1,OF2),Kasturba Hospital, Manipal, Udupi, Karnataka,576104,India
Udupi
KARNATAKA 
9880884933

raghuraj.sk@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Preoperative education  Preoperative education related video of about 15 minutes and distribution of pamphlet. 
Comparator Agent  Standard care  Standard care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1)Adults aged 18 years and above.
2)Patients diagnosed with a lower limb fracture requiring surgical intervention.
3)Patients scheduled for elective lower limb fracture surgery in the selected tertiary care hospital.
4)Individuals are willing to participate and provide informed consent.
5)Patients are available during the data collection.
 
 
ExclusionCriteria 
Details  1)Critically ill patient.
2)Patients operated in other hospital.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Anxiety level, Pain level and Clinical outcomes  Anxiety - Pre-operative Baseline
Post operative - Day 1, Day 3, Day 5
Pain -Post operative - Day 1, Day 3, Day 5
Clinical outcomes-Post operative - Day 1, Day 3, Day 5  
 
Secondary Outcome  
Outcome  TimePoints 
No secondary outcome will be assessed  Not applicable 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   17/11/2025 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Lower limb fractures, commonly involving the tibia, fibula, patella, and ankle, are a significant global health concern, particularly due to road traffic accidents and osteoporosis-related fragility fractures. These injuries often require surgical intervention, such as open reduction and internal fixation (ORIF), to restore bone alignment and function. However, patients frequently experience preoperative anxiety and postoperative pain, which can delay recovery and prolong hospital stays. Preoperative education plays a vital role in reducing anxiety, improving pain management, and preventing postoperative complications by preparing patients mentally and physically for surgery. This research is important as it evaluates the effectiveness of preoperative education in enhancing recovery outcomes, shortening hospital stays, and improving overall patient satisfaction and quality of care in lower limb fracture surgeries.

This interventional study will be conducted in the orthopaedic ward of Kasturba Hospital, MAHE, Manipal, a tertiary care hospital in Udupi district, Karnataka. A total of 88 participants with lower limb fractures undergoing elective surgery and meeting inclusion criteria will be selected through purposive sampling and assigned to either the experimental group receiving structured preoperative education or the control group receiving routine care. No medications will be changed. Data will be collected at multiple time points: pre-operatively (background details and baseline anxiety) and post operatively (pain, anxiety, and clinical outcomes). Data will be collected using validated tools:

1.    Tool-1- Background information

a.      Section A: Demographic proforma

b.      Section B: Clinical Proforma

2.    Tool-2- The anxiety level of the adult patients with lower limb fracture undergone surgery will be measured by Visual Analog Scale for Anxiety (VAS-A)

3.    Tool-3- The pain level of the adult patients with lower limb fracture undergone surgery will be measured by NPRS (Numeric Pain Rating Scale).

4.    Tool-4- Clinical outcome assessment tool (Self Developed)

 

The objectives of the study are to:

1.    assess the anxiety among adult patients with lower limb fracture undergoing surgery.

2.    evaluate the effectiveness of pre-operative education on:

2.1.     anxiety among patients in the experimental group as compared to the control group.

2.2.     pain among patients in the experimental group as compared to the control group.

2.3.     clinical outcome among patients in the experimental group as compared to the control group.

Data will be analyzed using Jamovi 2.6.44. Descriptive statistics (mean, SD, frequency, percentage) will summarize demographic data, anxiety, pain, and clinical outcomes. A paired t-test will compare pre- and post-operative anxiety within groups, while an independent t-test will assess differences in post operative anxiety, pain, and clinical outcomes between the experimental and control groups.


 
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