| CTRI Number |
CTRI/2024/04/066081 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse led package for women undergoing endometrial biopsy for selected variables] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of nurse education package on stress, pain and anxiety among women undergoing Endometrial biopsy. |
|
Scientific Title of Study
|
A Randomized Controlled Trial study to assess the effectiveness of nurse led educational package for Endometrial biopsy on selected variables among the women undergoing Endometrial biopsy in gynae OPD,New OPD,PGIMER,Chandigarh 2023-24 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratibha kumari |
| Designation |
post basic bsc nursing student |
| Affiliation |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research |
| Address |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Sector 12,Chandigarh,India
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Sector 12,chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8409061518 |
| Fax |
|
| Email |
pratibha042596@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manpreet Kaur |
| Designation |
Nursing tutor |
| Affiliation |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research |
| Address |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Sector 12,Chandigarh,India
National Institute of Nursing Education,
Pgimer,sector 12,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814822481 |
| Fax |
|
| Email |
manpreet.patti2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manpreet Kaur |
| Designation |
Nursing tutor |
| Affiliation |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research |
| Address |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Sector 12,Chandigarh,India
PGIMER,Sector 12,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814822481 |
| Fax |
|
| Email |
manpreet.patti2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education,PGIMER,secto 12,Chandigarh,160012 |
|
|
Primary Sponsor
|
| Name |
Pratibha kumari |
| Address |
National institute of Nursing Education,Post Graduate Institute of Medicak Education and Research,sector 12,Chandigarh,160012 |
| 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 |
| Pratibha kumari |
hospital based trial |
Minor OT,Gynae opd,new opd,Obstetric and Gynaecology department,post graduate institute of medical education and research,sector 12, chandigarh
Chandigarh
CHANDIGARH |
8409061518
pratibha042596@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE of NINE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
routine care for women undergoing endometrial biopsy |
| Intervention |
nurse-led educational package |
Nurse led educational package which includes 4 components:knowledge regarding female reproductive system, endometrial biopsy, relaxation techniques including deep breathing exercises,jakobsons muscle relaxation technique ,guided imagery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
women undergoing endometrial biopsy and are willing to take part in research study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| stress , anxiety and pain among women undergoing endometrial biopsy |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stress , anxiety and pain among women undergoing endometrial biopsy |
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
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="1"
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
|
nurse led educational package is a protocol that uses in the women undergoing endometrial biopsy to reduce stress ,anxiety and pain among such patients. Nurse-led educational package:-It includes interview schedule and nurse led educational package including knowledge regarding female reproductive system and endometrial biopsy, relaxation techniques including deep breathing exercise, Jakobson’s muscle relaxation technique and guided imagery. observation checklist and feedback proforma to be filled during and after endometrial biopsy. |