Nursing CariesNCT04759118
The Effectiveness of Modified Childbirth Education Program
A study testing modified childbirth education program in people with Nursing Caries, run by Endang Koni Suryaningsih at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- modified childbirth education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- First-time pregnancy (nullipara)
- Gestational age of 28 to 35 weeks
- Married
- Residents of Yogyakarta
- Singleton pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prenatal Childbirth Program on Maternal Anxiety, Maternal-Fetal Attachment,
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.
Read the detailed description
The curriculum of the modified childbirth education (CE) program was created along with suggestions and recommendations from experts. The participants were recruited from five different health centers in Yogyakarta. the computer random block size was applied to determine the randomization (sequence 4,6,8) and allocation concealment was assured by using sequentially numbered, opaque, sealed envelopes. 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. The materials and learning methods as the control process are expected to influence the four modes as the effectors that can reduce maternal anxiety and increase maternal-fetal attachment, childbirth self-efficacy, as well as marital satisfaction as the outcomes of adaptation level. The study setting for the intervention group was conducted at the antenatal care laboratory of 'Aisyiyah University of Yogyakarta. For safety and protocol concerns during the pandemic Corona Virus Disease-19 situation, the class was set up in a big classroom and adequate ventilation that can accommodate 12 couples and is equipped with yoga mats and pillows, as well as convenient access to a restroom. The couples and researcher team were required to wear masks and wash their hand before and after entering the class. Research assistants printed handouts and lead the group through WhatsApp application to following up practicing skills at home and also respond to the question from the participant at any time. During the intervention, the health workers from the participating health centers have been invited to observe the intervention. Classes consisted of 180-minute sessions held once a week for four weeks
The control group participants in this study have attended standard childbirth education classes during the same period as the intervention group. The control group classes were conducted at the primary health centers where they were recruited, not at the university. 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. For the fourth class, the control group has a half-hour to fill out the questionnaires and a half hour for feedback and discussion. Then the researcher and assistants have provided the control group participants with a condensed two-hour class of prenatal yoga, comfort measures, and maternal-fetal attachment activities. We conducted online briefing sessions with midwives who are the childbirth education program facilitator at five health centers. The briefing discussed the objectives of the study, the administration of the questionnaire, and the quality control issues relating to biases, fabricated data, missing data, and ethical issues. These were established in an effort to ensure consistency in the process of data collection.
- Conditions
- Nursing Caries
- Being tested
- modified childbirth education program
- Keywords
- Randomized control trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified childbirth education programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: modified childbirth education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: 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."
Measured: 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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Dec 2019
- Primary completion18 Feb 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endang Koni Suryaningsih
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Endang Koni Suryaningsih, National Taipei University of Nursing and Health Sciences
- Investigators
- Endang K Suryaningsih, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759118
- Sponsor's protocol ID
- 1303/KEP-UNISA/XI/2019
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prenatal Childbirth Program on Maternal Anxiety, Maternal-Fetal Attachment,
- ClinicalTrials.gov ID
- NCT04759118
- Acronym / sponsor ID
- 1303/KEP-UNISA/XI/2019
- Conditions
- Nursing Caries
- Keywords
- Randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Endang Koni SuryaningsihUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The curriculum of the modified childbirth education (CE) program was created along with suggestions and recommendations from experts. The participants were recruited from five different health centers in Yogyakarta. the computer random block size was applied to determine the randomization (sequence 4,6,8) and allocation concealment was assured by using sequentially numbered, opaque, sealed envelopes. 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. The materials and learning methods as the control process are expected to influence the four modes as the effectors that can reduce maternal anxiety and increase maternal-fetal attachment, childbirth self-efficacy, as well as marital satisfaction as the outcomes of adaptation level. The study setting for the intervention group was conducted at the antenatal care laboratory of 'Aisyiyah University of Yogyakarta. For safety and protocol concerns during the pandemic Corona Virus Disease-19 situation, the class was set up in a big classroom and adequate ventilation that can accommodate 12 couples and is equipped with yoga mats and pillows, as well as convenient access to a restroom. The couples and researcher team were required to wear masks and wash their hand before and after entering the class. Research assistants printed handouts and lead the group through WhatsApp application to following up practicing skills at home and also respond to the question from the participant at any time. During the intervention, the health workers from the participating health centers have been invited to observe the intervention. Classes consisted of 180-minute sessions held once a week for four weeks
The control group participants in this study have attended standard childbirth education classes during the same period as the intervention group. The control group classes were conducted at the primary health centers where they were recruited, not at the university. 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. For the fourth class, the control group has a half-hour to fill out the questionnaires and a half hour for feedback and discussion. Then the researcher and assistants have provided the control group participants with a condensed two-hour class of prenatal yoga, comfort measures, and maternal-fetal attachment activities. We conducted online briefing sessions with midwives who are the childbirth education program facilitator at five health centers. The briefing discussed the objectives of the study, the administration of the questionnaire, and the quality control issues relating to biases, fabricated data, missing data, and ethical issues. These were established in an effort to ensure consistency in the process of data collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: modified childbirth education programThe 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- First-time pregnancy (nullipara)
- Gestational age of 28 to 35 weeks
- Married
- Residents of Yogyakarta
- Singleton pregnancy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified childbirth education programThe 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. | Behavioural | Experimental group |
Primary outcome
Maternal anxiety
Time frame: four weeks
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").
Maternal-fetal attachment
Time frame: Four weeks
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.
Childbirth Self-efficacy
Time frame: Four weeks
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."
Marital Satisfaction
Time frame: Four weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Endang K Suryaningsih principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified childbirth education program in people with Nursing Caries, run by Endang Koni Suryaningsih at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal anxiety (time frame: four weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.