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临床试验/CTRI/2024/09/074262
CTRI/2024/09/074262进行中(未招募)不适用

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

INHS Dhanvantari1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
To assess the knowledge of labor analgesia among pregnant women in the island.

研究概览

简要总结

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.

  1. 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
  1. No. of previous Normal delivery
  • First pregnancy
  • 1
  • 2
  • 3 or more
  1. No. of previous LSCS
  • First pregnancy
  • 1
  • 2
  • 3 or more
  1. No. of previous Abortion(s)
  • First pregnancy
  • 1
  • 2
  • 3 or more
  1. Education Level:
  • No formal education
  • Primary education
  • Secondary education
  • Higher secondary education
  • Graduate
  • Postgraduate
  1. Occupation:
  • Homemaker
  • Employed
  • Self-employed
  • Student
  • Others (please specify) __________
  1. 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
  1. 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) __________
  1. 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
  1. 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
  1. 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
  1. 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) __________
  1. Do you believe that having an epidural means you are more likely to have a cesarean section?
  • Yes
  • No
  • I don’t know
  1. Would you consider using labor epidural analgesia during your childbirth?
  • Yes
  • No
  • Not sure
  1. 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)
  1. If yes, how would you rate your experience with labor epidural analgesia?
  • Very satisfied
  • Satisfied
  • Neutral
  • Dissatisfied
  • Very dissatisfied
  1. Have you discussed labor pain management options, including epidurals, with your healthcare provider?
  • Yes
  • No
  1. Do you plan to discuss labor epidural analgesia with your healthcare provider during your current pregnancy?
  • Yes
  • No
  • Not sure
  1. 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) __________

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • (a) Pregnant women attending the OPD.
  • (b) Women aged 18 and above.
  • (c) Women who consent to participate in the study.

排除标准

  • (a) Non pregnant women (b) Women who are not willing to participate.

结局指标

主要结局

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

时间窗: 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 understand the attitudes of pregnant women towards labor analgesia.

时间窗: 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 evaluate the practices and experiences of pregnant women regarding labor analgesia.

时间窗: 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.

次要结局

  • NA(NA)

研究者

发起方
INHS Dhanvantari
申办方类型
Other [Govt Hospital]
责任方
Principal Investigator
主要研究者

Soham Das

INHS Dhanvantari

研究点 (1)

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