| 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
|
|
|
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
|
|
|
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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