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CTRI Number  CTRI/2024/09/073902 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nurse led follow up ]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   nurse-led follow-up post-knee replacement surgery influence pain intensity and activities of daily living compared to standard post-operative care. 
Scientific Title of Study   Effect of post-surgical nurse-led follow-ups on pain intensity and activities of daily living among patients with knee replacement: A quasi-experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha chaudhary 
Designation  M.S.c Nursing Student  
Affiliation  AIIMS JODHPUR  
Address  Seminar hall-2, First floor, College of Nursing , AIIMS JODHPUR, Basni phase-2.

Jodhpur
RAJASTHAN
342005
India 
Phone  8368337691  
Fax    
Email  meghachaudhary001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Vandna Pandey  
Designation  Assisstant Professor 
Affiliation  COLLEGE OF NURSING, AIIMS JODHPUR 
Address  Room no.- 102, First floor, College of Nursing, AIIMS JODHPUR, Basni phase-2.

Jodhpur
RAJASTHAN
342005
India 
Phone  9309398688  
Fax    
Email  vandna.pandey80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mrs Vandna Pandey  
Designation  Assisstant Professor 
Affiliation  COLLEGE OF NURSING, AIIMS JODHPUR 
Address  Room no.- 102, First floor, College of Nursing, AIIMS JODHPUR, Basni phase-2.

Jodhpur
RAJASTHAN
342005
India 
Phone  9309398688  
Fax    
Email  vandna.pandey80@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR RAJASTHAN, 342005, INDIA. 
 
Primary Sponsor  
Name  NON SPONSORED 
Address  NON SPONSORED 
Type of Sponsor  Other [] 
 
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 
Megha Chaudhary  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, AIIMS JODHPUR  Third floor Orthopedic unit of AIIMS JODHPUR Basni phase-2, 342005,
Jodhpur
RAJASTHAN 		 8368337691

meghachaudhary001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, AIIMS JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nurse led follow up  Participants in the experimental group will receive additional nurse-led follow-ups, in addition to the standard treatment, on the day before discharge. Nurse led follow-ups will include: A animated video of approximate 10min. to 12min. will be used to deliver extensive education, offer guidance and reinforce key points after baseline data collection. Telephonic reinforcement will be done for ensuring the compliance of interventions taught to patients during video-based education. The video will contain following components- 1. Self-care (bathing, toileting and weight management) 2. Sitting time and position 3. Use of ambulatory aids and supportive device 4. Exercise follow up 5. Medication and supplement the patients will be follow up at 2 weeks ,4 weeks, 6weeks.  
Comparator Agent  Routine care   Control group will receive standard routine care by orthopedic unit of AIIMS JODHPUR  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients who are willing to participate.
2. Post-operative knee replacement (unilateral or bilateral) patients admitted to orthopedic unit at AIIMS Jodhpur.
3. Patients above 18 years of age.
4. Patients are able to understand Hindi language  
 
ExclusionCriteria 
Details  The patients with the known cases of major psychiatric illness or neurological problems. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To assess and compare the effectiveness of nurse-led follow-ups on pain intensity among the patients with knee replacement.
• To assess and compare the effectiveness of nurse-led follow-ups on activities of daily living among the patients with knee replacement.
 		 2 weeks, 4 weeks , 6weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
• To determine association of pain with selected demographical variables among patients with knee replacement.
• To determine association of activity of daily living with selected demographical variables among patients with knee replacement.
• To find correlation between activities of daily living and pain among patients with knee replacement.
 		 6 week 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   19/09/2024 
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="6"
Days="0" 
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 - NO
Brief Summary  

Post knee replacement complication and pain can be decrease by health education and regular follow up of the patient. These changes can be applied more effectively if the patient actively involve in the process.

Therefor additional nurse led follow ups in addition to standard treatment on the day before discharge of patients with knee replacement  in india could be used as an intensive approch to reduce the complication and pain.

STEP 1: Enrollment

Patients with Knee Replacement (TKR) and admitted to AIIMS Jodhpur will be enrolled in the study. Written consent will be obtained from each patient, ensuring that they are fully informed about the study’s purpose. Patients will also be briefed on the necessary follow-up procedures.

STEP 2: Baseline Data collection

The baseline data will be collected from the enrolled patients which will include the socio-demographic variables such as age, gender, height, weight, BMI, education, occupation, comorbidities, surgical history and type of surgery.

STEP 3: Non-random allocation of participants to both groups

 Initially patients, with Knee Replacement (TKR) with all the inclusion criteria will be assigned to the control group, and baseline data will be collected thereafter patients will be assigned inexperimental group and intervention will be provided to experimental group after collecting baseline data.

STEP 4: Intervention

Participants in the control group will undergo the standard treatment protocol provided by the orthopedic department.

Participants in the experimental group will receive additional nurse-led follow-ups, in addition to the standard treatment, on the day before discharge.

Nurse led follow-ups will include: A animated video of approximate 10min. to 12min. will be used to deliver extensive education, offer guidance and reinforce key points after baseline data collection.

Telephonic reinforcement will be done for ensuring the compliance of interventions taught to patients during video-based education.

The video will contain following components-

·       Self-care (bathing, toileting and weight management)

·       Sitting time and position

·       Use of ambulatory aids and supportive device

·       Exercise follow up

·       Medication and supplement  

STEP 5: Data collection

The Numerical Pain Rating Scale (NPRS) and Katz index of independence in activities of daily living scale will be administered on both control and experimental group to assess pain intensity and activities of daily living on first follow up at 2 weeks, second follow up at 4weeks and third follow up at 6week. Interview method will be used for data collection.

STEP 6: Data analysis

Thereafter, collected data will be coded and entered in master sheet for analysis.

PLAN FOR DATA ANALYSIS

Statistical analysis will be performed using statistical package for social sciences programme (SPSS).
 Quantitative data analysis will be done with the help of descriptive statistics i.e., mean, percentage, frequency and standard deviation.

Inferential statistics will be used to assess the research hypothesis and effectiveness of nurse-led follow up on knee replacement patients.

The level of significance will be set as p<0.05.

 

Data analysis plan:

Statistical analysis will be performed using statistical package for social sciences programme (SPSS).

Quantitative data analysis will be done with the help of descriptive statistics i.e., mean, percentage, frequency and standard deviation.

Inferential statistics will be used to assess the research hypothesis and effectiveness of nurse-led follow up on knee replacement patients.

The level of significance will be set as p<0.05.


Duration of study  
The study will be completed in the duration of 6 month.
 
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