Evaluation of the effect of childbirth preparation educational program on self-efficacy, anxiety, and birth outcomes among first time Jordanian mothers.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001255471
• Date of registration: 07/09/2016
• Prospective Registration: Yes
• Primary sponsor: Jordan university of science and technology
• Public title: Evaluation of the effect of childbirth preparation educational program on self-efficacy, anxiety, and birth outcomes among first time Jordanian mothers.
• Scientific title: Evaluation of the effect of childbirth preparation educational program on self-efficacy, anxiety, and birth outcomes among first time Jordanian mothers.
• Date of first enrolment: 01/10/2016
• Target sample size: 128
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616001255471.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Jordan

Contacts

• Name: Dr reem hatamleh

• Name: Dr sana' abujilban

Key inclusion & exclusion criteria

Inclusion criteria: The target population is all Jordanian primigravida pregnant women and the accessable population is the women who attend the antenatal clinics at king Hussein medical center. To overcome the effect of extraneous variables on the study outcomes, the inclusion criteria will include participants who are healthy primiparous, aged 18-45 years, pregnant for at least 32 weeks and have low risk singleton pregnancy. Only woman who planned to deliver at king Hussien Medical Center, and who possess a smart phone will be recruited.
Exclusion criteria: high risk pregnancy

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Antenatal care

pregnancy;
pregnancy

Intervention(s)

Study Procedures
The researcher will have the permission from the head nurse of maternity ward at king Hussein Medical Center (KHMC) to access the study participants. The study will advertise in a poster which will be placed at antenatal clinics at KHMC. It will include the study title, aims, benefits and the inclusion criteria. Recruitment will be conducted by the researcher between June and July 2016. Pregnant women who met the inclusion criteria will be approached and kindly asked to participate. If the women agreed to participate, they will receive a letter explaining the study, as well as the consent form, which they accordingly will sign. Subsequently, the women will complete their basic demographic sheet and will be randomly assigned into two groups.
Upon recruitment a pre-intervention questionnaire of Childbirth Self-Efficacy Inventory (CBSEI) and State Anxiety Inventory will be administered to women allocated to the intervention group and the control groups at antenatal clinics. Sessions will be scheduled with women (interventional group) agreement according to their clinic appointments. After that women (interventional group) will have an orientation round for the maternity ward and they will have a pamphlet with educational session’s schedule. At the end of intervention (attending childbirth educational program) the post-intervention questionnaires; Childbirth Self-Efficacy Inventory (CBSEI) and State Anxiety inventory will be administered. Women who allocated to the control group will receive usual antetnatal care and there will be no attempt to control information from other sources but if women in the control group asked about any obstetric procedure, the usual information or care will be provided.
Each woman in both groups will be provi

Primary Outcome(s)

Childbirth Self-Efficacy Inventory (CBSEI) will be used to assess appraisals of birth self-efficacy beliefs and outcome expectancies (Lowe, 1993). The original version of the scale consists of two parallel subscales: The items on the self-efficacy (EE-16) scales are rated from 0 (not at all sure) to 10 (very sure); women will be asked to indicate their ability to use any behavior to help them coping with childbirth, e.g. ‘Concentrate on getting through one contraction at a time’. Items on the outcome expectancy (OE-16) scales are rated from 0 (not at all helpful) to 10 (very helpful). Psychometric properties of the scale have been confirmed with reliability coefficients above 0.90 among pregnant women (Drummond & Rickwood, 1997; Sinclair & O’Boyle, 1999). In the original version, each subscale that measure the coping behaviour for childbirth, were adopted for measuring the women’s perceived coping ability on the entire labour process instead of the two separate stages. In considering the repetitive items of the original CBSEI, the short version was examined in a clinical Chinese pregnant population for reliability and validity; the presented information supports the use of the short form of the Childbirth Self-Efficacy Inventory as a research instrument in measuring the childbirth self-efficacy (W.-Y. Ip, Chung, & Tang, 2008). The short version of this scale will be used in this study. The Arabic version of childbirth self-efficacy scale will be borrowed for use after permission; it was validated in Arabic version within a Jordanian study (Abujilban, Sinclair, & Kernohan, 2012).

[32- 37 weeks gestation for pre-test and three weeks later for post-test]

state anxiety
The State Trait Anxiety Inventory consists of 20 brief statements in two comparable Arabic and English versions. Each statement is answered on a 4- point intensity scale, anchored by 1 (rarely) and 4 (always). The scale Reliabilities are ranged from 0.88 to 0.92 (alpha) and between 0.70 and 0.93 (test–retest), which representing good internal consistency and stability. The range of criterion-related validity of the scale ranges between 0.70 and 0.88 (5 criteria), while the loading of the scale on a general factor of anxiety was 0.93, demonstrating the scale’s criterion related and factorial validity. The Arabic version of STAI scale will be borrowed for use with permission (Abdel-Khalek, 2000). [32- 37 weeks gestation for pre-test and three weeks later for post-test]

Secondary Outcome(s)

Birth trauma: (assessed by review of medical records).
? Bruising ? Cephalohaematoma ? Facial Palsy ? Scalp injury
? Erbs Palsy ? Cerebral Palsy ? other……….
[24- 48 after delivery]

Did the women need Episiotomy? (assessed by review of medical records). ? No ? Yes[24- 48 after delivery]

Type of cesarean section is: (assessed by review of medical records).
? elective ? urgent
[24- 48 after delivery]

Type of delivery: (assessed by review of medical records).
? Vaginally ? Caesarean section ? Instrumental birth [24- 48 after delivery]

Apgar score at 1st minute………………
(assessed by review of medical records).[24- 48 after delivery]

Baby Birth weight: ……………………Kg. (assessed by review of medical records).[24- 48 after delivery]

Did the mother experience any Post-partum hemorrhage? (assessed by review of medical records).
?None ? Primary ? Secondary
[24- 48 after delivery]

Did the woman need any electronic fetal heart rate monitoring? (assessed by review of medical records).
? No ? Yes
[24- 48 after delivery]

Did the woman experience any type of lacerations? (assessed by review of medical records). ? No ? Yes
if yes, please chose the site of the laceration (assessed by review of medical records).
? Uterine laceration ? Cervical laceration ? Vaginal Laceration ? Perineal laceration
If Perineal laceration; which degree? (assessed by review of medical records).
? 1st degree ? 2nd degree ? 3rd degree ? 4th degree
[24- 48 after delivery]

Indication for cesarean section is: (assessed by review of medical records).
? Fetal distress ? Shoulder dystocia ? Failed induction ? Precious baby
? Failed Forceps ? Failed vacuum ? Prolonged labour ? Eclampsia
? breech ? Abruptio placenta ? Palcenta previa ? Small pelvic outlet
others……….
[24- 48 after delivery]

Does the baby need any assisted newborn ventilation? ? No ? Yes
(assessed by review of medical records). [24- 48 after delivery]

Apgar score at 5 minutes………………(assessed by review of medical records).[24- 48 after delivery]

Did the mother receive any pain medications during labour? (assessed by review of medical records).
? No ? Yes
if yes, please choose the type of pain medication that mother have received: (assessed by review of medical records).
? Analgesics ? Local Anesthesia ? Regional Blocks: Epidural or Spinal Block
? General Anesthesia ? others
[24- 48 after delivery]

Baby a live: ? No ? Yes
(assessed by review of medical records).[24- 48 after delivery]

Baby is : ? Boy ? Girl
(assessed by review of medical records).[24- 48 after delivery]

Onset of breast feeding ……………………hrs.
(assessed by review of medical records).[24- 48 after delivery]

Labour onset is: (assessed by review of medical records).
? spontaneous ? induced
[24- 48 after delivery]

Gestational age: ………………………weeks.
(assessed by review of medical records).[24- 48 after delivery]

Post natal medications: (assessed by review of medical records).
? Pain killer (injectable) ? Pain killer (tablet) ? Antibiotic(injectable)
? Antibiotic (tablet) ? other…………
[24- 48 after delivery]

Length of first stage: --------------------hrs. (assessed by review of medical records).[24 -48 hrs post delivery]

Length of hospital stay: ………………….hrs. (assessed by review of medical records).[24- 48 after delivery]

Secondary ID(s)

none

Source(s) of Monetary Support

asma' abuabed

Secondary Sponsor(s)

Dr Reem hatamleh

Ethics review

Status: Approved
Approval date:
Contact:

Jordan University of science and technology Institutional Review Board (IRB).

Status: Approved
Approval date:
Contact:

jordanian royal medical services ethics commitee