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CTRI Number  CTRI/2024/02/062292 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 23/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral
Other (Specify) [nurse led education]  
Study Design  Other 
Public Title of Study   assess the post-operative complications and functional outcome among patients planned to undergo TURP 
Scientific Title of Study   Effect of nurse led educational interventions on prevention of post-operative complication and functional outcome among patients planned to undergo TURP : A Quasi experimental study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohd Parvez 
Designation  PG student 
Affiliation  AII INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR 
Address  Marudhar basin 2nd Phase AIIMS JODHPUR RAJASTHAN 342005
marudhr basni 2nd phase AIIMS JODHPUR 342005
Jodhpur
RAJASTHAN
342005
India 
Phone  7727862304  
Fax    
Email  parvezyakub00@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Nipin kalal 
Designation  Assistant Professor 
Affiliation  All india institute of medical sciences 
Address  MARUDHER PHASE 2ND BASNI JODHPUR 342005
COLLEGE OF NURSING AIIMS JODHPUR RAJASTHAN 342005
Jodhpur
RAJASTHAN
342005
India 
Phone  8955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Nipin kalal 
Designation  Assistant Professor 
Affiliation  All india institute of medical sciences 
Address  COLLEGE OF NURSING AIIMS JODHPUR RAJASTHAN 342005
COLLEGE OF NURSING AIIMS JODHPUR RAJASTHAN 342005
Jodhpur
RAJASTHAN
342005
India 
Phone  8955945598  
Fax    
Email  kalalnipin@gmail.com  
 
Source of Monetary or Material Support  
MOHD.PARVEZ and AIIMS Jodhpur MARUDHER PHASE 2ND BASNI JODHPUR 
 
Primary Sponsor  
Name  Non sponsored 
Address  Non sponsored 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
Non sponsored  Non sponsored 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MohdParvez  AIIMS  College of Nursing AIIMS Jodhpur Rajasthan 342005
Jodhpur
RAJASTHAN 		 7727862304

parvezyakub00@gmail.com 
MRNIPIN KALAL  ALL INDIA ISTITUTE OF MEDICAL SENCES,JODHPURCO  COLLEGE OF NURSING MARUDHER PHASE 2ND BASNI JODHPUR
Jodhpur
RAJASTHAN 		 8955945598

Kalalnipin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, AIIMS, jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, (2) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NURSE LED EDUCTIONAL INTERVENTION TO PREVENT POST OPERATIVE COMPLICATON AND FOLLOW UP PROGRAM  Control group participants will receive the standard routine care to undergo TURP as per Urology IPD. Experimental group participants will receive following intervention along with the standard routine care to undergo TURP: Part 1 – Health Education: The Experimental group will be provided with health education about self-management strategies (for example avoid strenuous activity, such as heavy lifting, for four to six weeks or move any heavy object or avoid sexual activity for last four to six week , drinking plenty of water . ) specific changes in behavior (such as bladder retraining i.e., pelvic floor exercises, double voiding, and urethral milking) and avoidance of constipation with dietary changes. PART 2- Pamphlet distribution: Education pamphlet along with a compliance sheet will be provide to the experimental group patients immediately after health education. The pamphlet will include following components definition, benefit of procedure, and possible post-operative complication, all self-management strategies and specific changes in behavior explained above and expected future complication. Part 3 – Telephone follow-up: Telephonically confirmation and reinforcement will be done once weekly for ensuring the compliance of interventions taught to the patient during Nurse led education (will also be reminded to maintain and regularly fill the compliance sheet). STEP 5: Post-intervention data collection After 12 weeks post-intervention, post-operative complications will be assess in control and experimental group. Questionnaires (IPSS, IIEF,) will be administered on both control and experimental group by direct face to face interview. Self-report and interview method will be used for collecting data. STEP 6: Data analysis Thereafter, collected data will be coded and entered in master sheet for analysis. 
Comparator Agent  PREVENTIVE CARE  PREVENTIVE CARE 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1. Patients above 40 years of age.
2. Patients who will be willing to give consent and time of data collection in the study.
3. Patients who can understand Hindi or English.
 
 
ExclusionCriteria 
Details  1. Patients, who will not be able to receive, understand or respond to instructions.
2. Patients who had an open prostatectomy, A patient who had unsuccessful TURP.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional outcome that will be assessed by IIEF and IPSS  IPSS in 1 month and IIEF in 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative complications  1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   10/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/02/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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 -operative complications can be decreased by health education and  improve functional  outcomes after TURP. These changes can be applied more effectively if the patient actively involves in the process.

therefore a nurse -led intervention education after TURP In India could be used as an intensive approach to reduce the complications and improve the functional outcomes.

STEP 1: Enrollment

The patients planned to undergo TURP from Urology IPD will be recruited and informed written consent will be obtained from the patients for conducting the study, and the patients will be informed about the follow-up check-up requirement.

STEP 2: Baseline Data collection

The baseline data will be collected from the enrolled patients which will include the Sociodemographic Variables (Age, Education, Occupation, Religion, Marital status and Area of residence), Clinical Variables (This part comprised; BPH signs and symptoms, medical diagnosis, associated comorbidities, and length of hospital stay. This part represented the baseline of the patient’s characteristics and their medical conditions and postoperative complications included hemorrhage, urinary tract infections, urinary retention, weak urinary stream and urinary incontinence.

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

Initially enrolled planned to undergo TURP will be assigned to Control group and then after the completion of baseline data collection and informing about follow-up requirement to control group, consecutive TURP Patients will be assigned to experimental group.

STEP 4: Intervention

Control group participants will receive the standard routine care to undergo TURP as per Urology IPD.

Experimental group participants will receive following intervention along with the standard routine care to undergo TURP:

Part 1 – Health Education: The Experimental group will be provided with health education about self-management strategies (for example avoid strenuous activity, such as heavy lifting, for four to six weeks or move any heavy object or avoid sexual activity for last four to six week , drinking plenty of water .  ) specific changes in behavior (such as bladder retraining i.e., pelvic floor exercises, double voiding, and urethral milking) and avoidance of constipation with dietary changes.

PART 2- Pamphlet distribution: Education pamphlet along with a compliance sheet will be provide to the experimental group patients immediately after health education. The pamphlet will include following components definition, benefit of procedure, and possible post-operative complication, all self-management strategies and specific changes in behavior explained above and expected future complication.

Part 3 – Telephone follow-up: Telephonically confirmation and reinforcement will be done once weekly for ensuring the compliance of interventions taught to the patient during Nurse led education (will also be reminded to maintain and regularly fill the compliance sheet).

STEP 5: Post-intervention data collection

After 12 weeks post-intervention, post-operative complications will be assess in control and experimental group. Questionnaires (IPSS, IIEF,) will be administered on both control and experimental group by direct face to face interview. Self-report and interview method will be used for collecting data.

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). Descriptive and inferential analysis will be done.

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

Pilot study: A try out will be conducted on ten percent of the study sample in a selected setting to evaluate the applicability & clarity of the tools.

 

DURATION OF STUDY 

The study will be completed in a period of 1 year.


 
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