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Clinical Trials/CTRI/2025/11/096755
CTRI/2025/11/096755
Not yet recruiting
Not Applicable

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.

Sonyog Maity1 site in 1 country88 target enrollmentStarted: November 17, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Sonyog Maity
Enrollment
88
Locations
1
Primary Endpoint
Anxiety level, Pain level and Clinical outcomes

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Adults aged 18 years and above.
  • Patients diagnosed with a lower limb fracture requiring surgical intervention.
  • Patients scheduled for elective lower limb fracture surgery in the selected tertiary care hospital.
  • Individuals are willing to participate and provide informed consent.
  • Patients are available during the data collection.

Exclusion Criteria

  • Critically ill patient.
  • Patients operated in other hospital.

Outcomes

Primary Outcomes

Anxiety level, Pain level and Clinical outcomes

Time Frame: 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 Outcomes

  • No secondary outcome will be assessed(Not applicable)

Investigators

Sponsor
Sonyog Maity
Sponsor Class
Other [Self funded (no external sponsor)]
Responsible Party
Principal Investigator
Principal Investigator

Sonyog Maity

Manipal College of Nursing, Manipal Academy of Higher Education ,Manipal

Study Sites (1)

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