The Effectiveness of Modified Childbirth Education Program

NCT04759118 | Completed DMC

• 1 other identifier: 1303/KEP-UNISA/XI/2019
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized control trial to test the effectiveness of childbirth education programs on maternal anxiety, maternal-fetal attachment, childbirth self-efficacy, and marital satisfaction based on Roy Adaptation Model. The modified childbirth education class as the experimental group was set up by PI following health authority guidelines in Indonesia. the measurement variable outcomes in the experimental group were compared to the control group after 4 weeks of intervention. statistical analysis applied to compare demographic characteristics between two groups as well as to compare the mean score of the variable between two groups.

Conditions

Nursing Caries

Keywords

Randomized control trial

Outcome Measures

Primary Outcomes (4)

• Maternal anxiety

  Pregnancy-related anxiety is defined as worries, concerns and fears about pregnancy, childbirth, and health of infant and future parenting. This outcome was measured using Pregnancy Related Anxiety Quistionnaire-Revised 2, developed by Van Den Bergh. consists of a 10-item self-report for multipara women, and an 11-item self-report for nulliparas. The scores on each item range from 1 (definitely not true) to 5 (definitely true). The 10-items consist of three subscales: items 1, 2, 6 and 8 are related to "fear of giving birth," items 4, 9, 10, and 11 are related to "worries about bearing a physically or mentally handicapped child," and items 3, 5, and 7 are related to body image or "concern about own appearance."The item 8 ("I am anxious about the delivery because I have never experience one before") will apply in this study since all the proposed participant are nulliparous, instead of item 1 ("I am anxious about the delivery").

  four weeks

• Maternal-fetal attachment

  The unique relationship between mother and unborn baby. This relationship is progress in line the number of gestation week since the mother will experience the presence of fetal movement. This outcome is assessed using Prenatal Attachment Inventory (PAI) developed by Muller. The instrument consist of 21 Likert-type items ranging from 1 ('almost never') to 4 ('almost always'). All items are summed for a single score, and the possible range of scores is 21-84. The author have culturally translated, produce the Indonesian version of PAI, and demonstrates high internal consistency.

  Four weeks

• Childbirth Self-efficacy

  The maternal coping ability regarding her confidence during childbirth. This outcome was assessed using Childbirth Self-Efficacy Inventory developed by Lowe. The instrument consist of 60 items divided to four subscales; OAL, ESS, OSS and ESS. A total Childbirth Outcome Expectancy Score (Outcome-Total) is computed by summing the Outcome-AL and Outcome-SS scale scores. A Total Self-Efficacy Expectancy Score (Efficacy-Total) is computed by summing the Efficacy-AL and Efficacy-SS scale scores. The example item: " Relax my body", " tell myself that I can do it", and "listen to encouragement from the person helping me."

  Four weeks

• Marital Satisfaction

  The outcome of marital satisfaction was measured using Evaluation and Nurturing Relationship Issues, Communication and Happiness (ENRICH) Marital Satisfaction Scale (EMS) was developed by Fower and Olson. The tool consist of a 15-item comprising the Idealistic Distortion (5 items) and Marital Satisfaction Scales (10 items). This scale is a Likert-type ranging from 1 (strongly disagree) to 5 (strongly agree) which is consist of positive and negative statement that indicate items scored direction. Items scored in negative direction would be reverse-scored (i.e if it is mark 5, it would be scored 1; it is marked 4, it would be scored 2; a 3 remain unchanged). The EMS Scale provides a score for each partner.

  Four weeks

Study Arms (2)

Control group

NO INTERVENTION

The participant in his group is a pregnant woman. The facilitators of the control groups were midwives who are already providing prenatal education classes at the clinics. The classes followed the government curriculum, which consists of three classes per month and does not invite husbands to participate. However, in this study, participants in the control group have four classes over a one-month period to better match the program of the intervention group. The material for the standard curriculum includes anatomical and physiological changes during pregnancy, pregnancy care, birth, and postpartum care. The classes also address family planning after giving birth, newborn care, preventing infectious disease, and procedures for obtaining a birth certificate. The midwives also discuss and debunk unhealthy local myths, beliefs, and cultural practices surrounding pregnancy, childbirth and the postpartum period

Experimental group

EXPERIMENTAL

The modified childbirth education program was applied in the experimental group. the intervention covered modification of content material, learning methods, and involving husband or other relatives during the class.

Behavioral: modified childbirth education program

Interventions

modified childbirth education program BEHAVIORAL

The participants in the intervention group are pregnant women and their husbands. The instructors employed teaching methods such as a group discussion, watching videos, and brainstorming, as well as questions and answer periods, demonstrations, childbirth simulation, and practice. The primary investigator (PI) will teach particular sessions, including maternal-fetal attachment skills, parenting skills, comfort measures, childbirth positions, as well as knowledge about anatomy and physiology during pregnancy and birth Classes consisted of 120-minute sessions held once a week for four weeks.

Experimental group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• First-time pregnancy (nullipara)
• Gestational age of 28 to 35 weeks
• Married
• Residents of Yogyakarta
• Singleton pregnancy

You may not qualify if:

• Mothers who miss the classes more than two times is considered to be excluded in the study. The mothers those who miscarry, and those whose pregnancies become high-risk, will be automatic excluded from the study

Sponsors & Collaborators

• Endang Koni Suryaningsih: lead

Study Sites (1)

Universitas 'Aisyiyah Yogyakarta

Yogyakarta, 55592, Indonesia

Location

Study Officials

• Endang K Suryaningsih

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 18, 2021
• Study Start: December 1, 2019
• Primary Completion: February 18, 2020
• Study Completion: March 30, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

ID (1)