| CTRI Number |
CTRI/2020/07/026439 [Registered on: 08/07/2020] Trial Registered Prospectively |
| Last Modified On: |
03/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nursing Care] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Peri-operative nursing guidelines of patients undergoing spinal surgery in Neurosurgery |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effectiveness of peri-operative nursing guidelines on selected outcomes of patient undergoing spine in surgery in neurosurgery unit, Nehru Hospital, PGIMER, Chandigarh 2019-21 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manju Dhandapani |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education,PGIMER , Chandigarh |
| Address |
National Institute of Nursing Education,Room no-12,Post Graduate Institute of Medical Education and Research,PGIMER Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
|
| Fax |
|
| Email |
manjuseban@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Dhandapani |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education,PGIMER , Chandigarh |
| Address |
National Institute of Nursing Education,Room no-12,Post Graduate Institute of Medical Education and Research,PGIMER Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
|
| Fax |
|
| Email |
manjuseban@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geeta Thapar |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education,PGIMER , Chandigarh |
| Address |
House No 3509 Sector 38 Chandigarh
National Institute of Nursing Education Post Graduate Institute of Medical Education and Research Chandigarh
Chandigarh
CHANDIGARH
160036
India |
| Phone |
|
| Fax |
|
| Email |
geeta3509@gmail.com |
|
|
Source of Monetary or Material Support
|
| No any source it is Self generated only |
|
|
Primary Sponsor
|
| Name |
Geeta Thapar |
| Address |
3509 Sector 38 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 |
| Dr Manju Dhandapani |
Post Graduate Institute of Medical Education and Research |
Neurosurgery Units Nehru Hospital Pgimer Chandigarh
Chandigarh
CHANDIGARH |
9855151528
manjuseban@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peri-operative Nursing Guidelines |
Peri-operative Nursing Guidelines on selected outcomes of patients undergoing spinal surgery |
| Comparator Agent |
routine care |
routine care |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients Posted for Spinal Surgery
Patients willing to participate in study |
|
| ExclusionCriteria |
| Details |
Patients with malignancy
Patients with altered sensorium
Patients posted for cervical spine surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Preoperative and postoperative anxiety of patients
Post operative pain,prevalence of constipation, Duration of indwelling catheter, Time of ambulation, Surgical site infection, Duration of hospital stay, Muscle strength, Functional outcome, Quality of life. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Preoperative and postoperative anxiety of patients
Post operative pain,prevalence of constipation, Duration of indwelling catheter, Time of ambulation, Surgical site infection, Duration of hospital stay, Muscle strength, Functional outcome, Quality of life. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/07/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Randomized Control Trial to Assess the Effectiveness of Peri -
Operative Nursing Guidelines on Selected Outcomes of Patient Undergoing Spinal
Surgery in Neurosurgery Unit, Nehru Hospital, PGIMER, Chandigarh, 2019-2021 Research
hypothesis
1
Null Hypothesis (Ho) –There will not be
any difference on peri-operative clinical outcomes on patients of spine
surgery, who received care according to perioperative guidelines and patients
who received routine care.
2
Alternate Hypothesis (H1) – The
peri-operative nursing outcomes of spine surgery patients who received care
according to the guidelines would be better as compared to patients who receive
routine care.
|