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CTRI Number  CTRI/2024/09/074262 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Knowledge, attitude, practice (KAP) study on Labor Analgesia among Pregnant Female Patients Attending OPD in Andaman and Nicobar 
Scientific Title of Study   Cross-Sectional knowledge, attitude, practice (KAP) study on Labor Analgesia among Pregnant Female Patients Attending OPD in a Secondary Care Hospital in Andaman and Nicobar 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Soham Das 
Designation  Specialist Anaesthesiology 
Affiliation  INHS Dhanvantari 
Address  Dept of Anaesthesiology INHS Dhanvantari Minniebay Port Blair Andaman and Nicobar

Andamans
ANDAMAN & NICOBAR ISLANDS
744103
India 
Phone  8390294535  
Fax    
Email  sohamdas.sd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Soham Das 
Designation  Specialist Anaesthesiology 
Affiliation  INHS Dhanvantari 
Address  Dept of Anaesthesiology INHS Dhanvantari Minniebay Port Blair Andaman and Nicobar

Andamans
ANDAMAN & NICOBAR ISLANDS
744103
India 
Phone  8390294535  
Fax    
Email  sohamdas.sd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Soham Das 
Designation  Specialist Anaesthesiology 
Affiliation  INHS Dhanvantari 
Address  Dept of Anaesthesiology INHS Dhanvantari Minniebay Port Blair Andaman and Nicobar

Andamans
ANDAMAN & NICOBAR ISLANDS
744103
India 
Phone  8390294535  
Fax    
Email  sohamdas.sd@gmail.com  
 
Source of Monetary or Material Support  
INHS Dhanvantari, Port Blair 
 
Primary Sponsor  
Name  INHS Dhanvantari 
Address  INHS Dhanvantari Minniebay Port Blair 
Type of Sponsor  Other [Govt Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Soham Das  INHS Dhanvantari  INHS Dhanvantari Minniebay Port Blair Andaman and Nicobar
Andamans
ANDAMAN & NICOBAR ISLANDS 
8390294535

sohamdas.sd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INHS Dhanvantari IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z333||Pregnant state, gestational carrier,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  (a) Pregnant women attending the OPD.
(b) Women aged 18 and above.
(c) Women who consent to participate in the study.
 
 
ExclusionCriteria 
Details  (a) Non pregnant women
(b) Women who are not willing to participate.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the knowledge of labor analgesia among pregnant women in the island.
To understand the attitudes of pregnant women towards labor analgesia.
To evaluate the practices and experiences of pregnant women regarding labor analgesia. 
To assess the knowledge of labor analgesia among pregnant women in the island.
To understand the attitudes of pregnant women towards labor analgesia.
To evaluate the practices and experiences of pregnant women regarding labor analgesia. 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/10/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

1. Introduction

Labor analgesia, particularly epidural analgesia, is an effective method for pain relief during childbirth. However, knowledge, attitudes, and practices (KAP) regarding labor analgesia among pregnant women can vary significantly. This study aims to assess the KAP of labor analgesia among pregnant female patients attending an OPD in a secondary care hospital in Andaman and Nicobar.

 2. Objectives

(a) To assess the knowledge of labor analgesia among pregnant women in the island.

(b) To understand the attitudes of pregnant women towards labor analgesia.

(c) To evaluate the practices and experiences of pregnant women regarding labor analgesia.

3. Review of Literature

Labor analgesia, especially epidural analgesia, is considered the gold standard for pain relief during labor in many developed countries. However, its acceptance and utilization in developing countries, including India, vary significantly due to factors like availability, cultural beliefs, and knowledge levels among expectant mothers.

A study by Le Ray et al. (2008) found that the use of epidural analgesia was significantly associated with social status of women and type of hospital attended.(1) In contrast, a study by Okojie et al. (2014) in a Nigerian hospital reported low awareness and uptake of epidural analgesia due to lack of proper information.(2)

In India, Hug et al.(2008) found that 70% of women are ready to accept labor pain as a natural phenomenon, while 78% were unaware of the intensity of pain to expect.(3) A study by Shidhaye et al. (2018) found that only 2% of the pregnant females are aware about epidural analgesia. (4) While Khan et al (2022) found almost one third patients being aware about painless labour, but less than 10% have availed epidural for labor pain relief.(5) Both the studies showed improved acceptance after receiving information about labour analgesia.

These studies underscore the need for targeted educational interventions to improve knowledge and attitudes towards labor analgesia, which can lead to better maternal and neonatal outcomes.

 4. Study Design

A cross-sectional descriptive study.

5. Study Setting

The study will be conducted in the Obstetrics and Gynaecology outpatient department (OPD) of a secondary care hospital in Andaman and Nicobar.

 6. Study Population

All pregnant women, who attends obstetrics and gynaecology OPD.

 7. Inclusion and Exclusion Criteria

Inclusion Criteria:

(a) Pregnant women attending the OPD.

(b) Women aged 18 and above.

(c) Women who consent to participate in the study.

Exclusion Criteria:

(a) Non pregnant women

(b) Women who are not willing to participate.

8. Sample Size

The sample size will be determined using the formula for cross-sectional studies:

n= Z2⋅p⋅(1−p)​/d2

Where:

 n = required sample size

Z = Z-value (e.g., 1.96 for 95% confidence level)

p  = estimated prevalence of knowledge/awareness of labor analgesia

d  = margin of error (typically 0.05)

Assuming a prevalence of knowledge about labor analgesia is 10% as per Poomalar et al (2016) (6)and a margin of error of 5%, the sample size calculation would be as follows:

 n = (1.96)2.0.1. (1-0.1)/(0.05)2 ≈ 138

Thus, a sample size of approximately 138 women will be required. Considering non-responses or incomplete data, a total of 200 women will be targeted.

9. Sampling Method

All pregnant women attending the obstetrics and gynaecology OPD during the period of study will be approached to select participants for the study.

10. Data Collection Tools

(a) A structured KAP questionnaire (as per appendix A).

(b) Demographic data collection form.

11. Data Collection Procedure

(a) Recruitment: Antenatal cases attending OPD will be identified and informed consent will be obtained.

(b) Administration of Questionnaire: The questionnaire will be administered by a multi language proficient trained interviewer.

(c) Data Entry: Responses will be recorded and entered into a google forms.

12. Data Analysis

(a) Descriptive Statistics:  To summarize demographic data and KAP responses.

(b) Knowledge Assessment:  Frequency and percentage of correct responses.

(c) Attitude Assessment: Frequency and percentage of positive, neutral, and negative attitudes.

(d) Practice Assessment: Frequency and percentage of reported practices and experiences.

(e) Statistical Tests:  Chi-square tests and logistic regression to identify associations between demographic variables and KAP scores.

13. Ethical Considerations

(a) Informed Consent: Written informed consent will be obtained from all participants.

(b) Confidentiality: Participant confidentiality will be maintained by using unique codes for data entry and analysis.

(c) Ethical Approval: The study protocol will be submitted for approval to the institutional ethics committee.

14. Limitations

(a) Self-reported data may be subject to recall bias or social desirability bias.

(b) The study is confined to a single centre in Andaman and Nicobar islands, which may limit generalisability.

15. Conclusion

This protocol outlines the methodology for a cross-sectional KAP study on labor analgesia among pregnant women in a remote island in Andaman and Nicobar. The results will provide valuable insights into the current state of knowledge, attitudes, and practices, which can inform healthcare strategies to improve maternal care.

16. Bibliography

1.            Factors associated with the choice of delivery without epidural analgesia in women at low risk in France - PubMed [Internet]. [cited 2024 Jul 28]. Available from: https://pubmed.ncbi.nlm.nih.gov/18844642/

2.            Okojie N, Isah E. PERCEPTION OF EPIDURAL ANALGESIA FOR LABOUR AMONG PREGNANT WOMEN IN A NIGERIAN TERTIARY HOSPITAL SETTING. J West Afr Coll Surg. 2014;4(4):142–62.

3.            Hug I, Chattopadhyay C, Mitra GR, Kar Mahapatra RM, Schneider MC. Maternal expectations and birth-related experiences: a survey of pregnant women of mixed parity from Calcutta, India. Int J Obstet Anesth. 2008 Apr;17(2):112–7.

4.            Shidhaye R, Galande M, Bangal V, Smita J, Shidhaye UR. Awareness and attitude of Indian pregnant women towards labour analgesia. INTENSIVE CARE. 2012;16.

5.            Khan IA, Malik N, Mishra R, Tiwari HC, Shahi V. Awareness, attitude and willingness to receive labour analgesia among pregnant women attending maternity hospitals in Eastern U.P. Clin Epidemiol Glob Health. 2022 Nov 1;18:101157.

6.            G.K. P, Sameera L. Awareness of labour analgesia among antenatal women in semi urban area. Int J Reprod Contracept Obstet Gynecol. 2016 Jan 1;2612–7. 


Appendix A

Demographics                                                           Date:____________

  1. Age                             : _____ yrs

2.      LMP                           :_______________ 

3.      EDD                           : ______________

4.       Gestational age         :________________

  1. Number of previous pregnancies:
    • First pregnancy
    • 1
    • 2
    • 3 or more
  2. No. of previous Normal delivery
    • First pregnancy
    • 1
    • 2
    • 3 or more
  3. No. of previous LSCS
    • First pregnancy
    • 1
    • 2
    • 3 or more
  4. No. of previous Abortion(s)
    • First pregnancy
    • 1
    • 2
    • 3 or more
  5. Education Level:
    • No formal education
    • Primary education
    • Secondary education
    • Higher secondary education
    • Graduate
    • Postgraduate
  6. Occupation:
    • Homemaker
    • Employed
    • Self-employed
    • Student
    • Others (please specify) __________
  7. Monthly Household Income:
    • Below ₹10,000
    • ₹10,000 - ₹25,000
    • ₹25,001 - ₹50,000
    • ₹50,001 - ₹1,00,000
    • Above ₹1,00,000

 

 

 

 

Appendix B

Section A: Knowledge

  1. Have you heard about labor epidural analgesia before?
    • Yes
    • No
  2. If yes, from where did you hear about it? (Select all that apply)
    • Doctor
    • Nurse
    • Family member
    • Friends
    • Internet/Social Media
    • TV/Radio
    • Books/Magazines
    • Others (please specify) __________
  3. What do you think is the purpose of labor epidural analgesia?
    • Pain relief during labor
    • To speed up labor
    • To prevent complications
    • I don’t know
  4. Which of the following do you think are possible side effects of labor epidural analgesia? (Select all that apply)
    • Headache
    • Backache
    • Nausea
    • Long-term back pain
    • Difficulty in pushing during labor
    • No side effects
    • I don’t know
  5. Do you think labor epidural can affect the baby?
    • Yes
    • No
    • I don’t know

Section B: Attitude

  1. How do you feel about the use of labor epidural analgesia during childbirth?
    • Strongly supportive
    • Supportive
    • Neutral
    • Opposed
    • Strongly opposed
  2. What are your main concerns about labor epidural analgesia? (Select all that apply)
    • Safety for the baby
    • Safety for the mother
    • Effectiveness in pain relief
    • Side effects
    • Cost
    • Availability
    • Others (please specify) __________
  3. Do you believe that having an epidural means you are more likely to have a cesarean section?
    • Yes
    • No
    • I don’t know
  4. Would you consider using labor epidural analgesia during your childbirth?
    • Yes
    • No
    • Not sure
  5. Who influences your decision the most regarding the use of labor epidural analgesia?
    • Yourself
    • Partner/Husband
    • Family member (Pls specify__________ )
    • Doctor
    • Friends
    • Others (please specify) __________

Section C: Practice

  1. Have you ever used labor epidural analgesia in any of your previous deliveries?
    • Yes
    • No
    • Not applicable (first-time mother)
  2. If yes, how would you rate your experience with labor epidural analgesia?
    • Very satisfied
    • Satisfied
    • Neutral
    • Dissatisfied
    • Very dissatisfied
  3. Have you discussed labor pain management options, including epidurals, with your healthcare provider?
    • Yes
    • No
  4. Do you plan to discuss labor epidural analgesia with your healthcare provider during your current pregnancy?
    • Yes
    • No
    • Not sure
  5. What other pain relief methods do you know about for labor? (Select all that apply)
    • Breathing exercises
    • Meditation/Relaxation techniques
    • Pain medications
    • Massage
    • Water birth
    • Others (please specify) __________


 
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