| CTRI Number |
CTRI/2023/08/056381 [Registered on: 10/08/2023] Trial Registered Prospectively |
| Last Modified On: |
07/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study done to assess the perception of labour pain relief management among mothers who undergo delivery at our institute. |
|
Scientific Title of Study
|
Perception of postnatal women on intrapartum analgesia in a tertiary care hospital - a Quantitative analysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpa Dan D |
| Designation |
Post Graduate Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore.
Vellore TAMIL NADU 632004 India |
| Phone |
9443518928 |
| Fax |
|
| Email |
shilpadan610@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Smitha Elizabeth George |
| Designation |
PROFESSOR |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore.
Vellore TAMIL NADU 632004 India |
| Phone |
9655820582 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shilpa Dan D |
| Designation |
Post Graduate Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore.
Vellore TAMIL NADU 632004 India |
| Phone |
9443518928 |
| Fax |
|
| Email |
shilpadan610@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant, Christian Medical College, Vellore - 632004, Tamil Nadu, Indi. |
|
|
Primary Sponsor
|
| Name |
Shilpa Dan D |
| Address |
Dr Shilpa Dan, Department of Anaesthesiology, Christian Medical College, Vellore 632004, Tamil Nadu, India. |
| Type of Sponsor |
Other [] |
|
|
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 Shilpa Dan D |
Christian Medical College |
Department of Anaesthesiology, Vellore. Vellore TAMIL NADU |
9443518928
shilpadan610@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Christian Medical College, Vellore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All women who had delivered in our institution via normal vaginal delivery, instrumental delivery, emergency Caesarean section |
|
| ExclusionCriteria |
| Details |
Women who are not willing to participate in the study
Women who have undergone elective Caesarean section
Women in the age group of less than 19 years or more than 40 years
Women who are unable to read and write on their own |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the perception of postnatal women on labour pain relief methods |
24hrs to 48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between socio-demographic factors & the perception on labour pain relief methods & labour epidural will be assessed. The variables in the questionnaire include age, level of education of the women, income, occupation, previous experience on labour, previous knowledge of epidural analgesia.
To find out the various reasons for the refusal of labour epidural among our postnatal patients.
|
24hrs to 48hrs |
|
|
Target Sample Size
|
Total Sample Size="256" Sample Size from India="256"
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)
|
17/08/2023 |
| 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="10" Days="30" |
|
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
|
Most of the women experience moderate to severe pain at the time of delivery. There are various labour pain relief methods available. This study will be done among postnatal women who will undergo delivery in our institution. All postnatal women in the early postpartum period during their stay in hospital after delivery will be included in this study after getting approval from IRB. Written informed consent will be obtained by the principal investigator from the postnatal women after explaining the purpose and intention of the study. First, a set of structured questionnaire will be prepared. These questions will contain three sections. First section will include the demographic characteristics. Second section will contain a set of self-administered questionnaire to assess the perception of labour analgesia and the third section to assess the perception toward labour epidural analgesia. Answer types include Yes/ No, multiple choice questions. This questionnaire will be tested out on a sample population of the postnatal women. The questionnaire will be validated by obstetricians, anaesthesiologists and staff nurses working in the labour room. The validated questionnaire will be given to the participants after taking consent in their preferred language and they will be requested to complete them. Investigators will also be available to clarify any doubts regarding the questions. The completed questionnaire will be collected, evaluated and analysed to assess the knowledge of the postnatal women about labour pain relief methods and the reasons for the refusal of labor epidural. |