| CTRI Number |
CTRI/2025/04/084625 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Nurse-Led Thoracolumbar Surgery care package] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a nurse-led thoracolumbar surgery care package on quality of life in patients undergoing thoracolumbar surgery. |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of a “Nurse-Led Thoracolumbar Surgery
care package” on quality of life and other related variables of patients with Thoracolumbar
surgery admitted in Neurosurgical and Orthopaedic Surgery Units, PGIMER, Chandigarh, 2024-
26. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaspreet Kaur |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh , PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316021308 |
| Fax |
|
| Email |
jaspreetkaur32994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monaliza |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room No. 318, Department of National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914477603 |
| Fax |
|
| Email |
monaliza.mittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Dhandapani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room No. 307,Department of National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855151528 |
| Fax |
|
| Email |
manjuseban@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing education, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Jaspreet Kaur |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jaspreet Kaur |
Nehru Hospital, PGIMER, Chandigarh |
Departments of Neurosurgery and Orthopedic Surgery and Advanced Trauma Centre
Chandigarh
CHANDIGARH |
9316021308
jaspreetkaur32994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M418||Other forms of scoliosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-Led Thoracolumbar Surgery
care package |
Preoperative Care: Thoracolumbar surgery education, postoperative pain management, mobility and rehabilitation guidance, nutritional optimization, and emotional support.
Postoperative Care: Pain management, monitoring of function, sensation, and reflexes, wound care, bowel and bladder care, breathing exercises and early mobilization.
Discharge & Home Care Interventions: Upon discharge, the care package includes instructions on a high-protein, balanced diet, encouragement of gentle activities, teaching proper body mechanics, promoting family involvement in recovery, and emphasizing the importance of medication adherence and follow-up care. |
| Comparator Agent |
Routine Care |
Preoperative Care: Preoperative education and counseling provided to all patients.
Postoperative Care: Pain management, wound care, mobility guidance, and general postoperative monitoring.
Discharge & Home Care: Routine discharge instructions, including basic dietary and activity recommendations. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients more than 18 years of age.
2. Patients who will understand Hindi, Punjabi, and English
3. Patients who will consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with Adult Scoliosis Deformity and with other Musculoskeletal disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
At the beginning of the third month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Neurologic Status
3. Respiratory Efficiency
4. Functional Independence |
On post-operative days 1 and 3, at discharge and in the
beginning of third 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 2 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="5"
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
|
This randomized controlled trial aims to assess the effectiveness of a Nurse-Led Thoracolumbar Surgery Care Package on improving the quality of life and other related outcomes in patients undergoing thoracolumbar surgery, admitted in the Neurosurgical and Orthopedic Surgery Units, PGIMER, Chandigarh. Consecutive sampling will be used to recruit participants, who will then be randomized via alternate day randomization. Approximately 30 patients will be assigned to the experimental group (receiving the care package) and 30 patients to the non-experimental group (receiving routine care). Outcomes will be measured at multiple time points, including preoperative, postoperative days 1 and 3, discharge, and at the beginning of the 3rd month after surgery. The study aims to provide evidence on the effectiveness of a nurse-led care approach in enhancing recovery and improving the quality of life for thoracolumbar surgery patients. |