Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001255471
Ethics application status
Approved
Date submitted
15/07/2016
Date registered
7/09/2016
Date last updated
7/09/2016
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 289683 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 299487 0
Condition category
Condition code
Reproductive Health and Childbirth 299566 299566 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 provided a contact number to call the researcher once she gets in labour. Birth outcomes which are the time of admission (no signs of labour, or latent first stage or active first stage), type of labour (augmented or induced) length of labour, type of delivery (Vaginally, Caesarean section, Instrumental), indication for cesarean section, type of labour (spontaneous or induced), using antibiotic or analgesic medications, type and duration of fetal monitoring, labour complications (perineal tears or hemorrhage), length of hospital stay, and neonatal outcomes (gestational age, birth weight, APGAR score, birth trauma, initiation of breastfeeding) will be obtained from medical records.
Audio visual materials
The researcher will provide the childbirth educational program for the women who allocated to the intervention group and will be scheduled into four educational sessions; it will be weekly, individualized, and for thirty minutes duration. The content of the educational program was derived from the standards of preparing the pregnant women for labour and delivery which was recommended within the Standards of Care for Health Centers and was published in (2002) by USAID and the Jordanian ministry of health; the Arabic version will be used in this study. During sessions a range of techniques will be used such as verbal information, discussion of issues or questions raised by the women and practical demonstration of breathing exercises. Women will be encouraged to ask questions about childbirth process. They will be educated about the anatomy and physiology of the reproductive system, signs of labour, labor and delivery process, labor relaxation techniques, postpartum care, breastfeeding, and how to pack her hospital bag. After each session the women will receive a pamphlet containing detailed information about what being explained and the content of each session will be shared with the women through their smart phone applications.
the role/qualification of the person running the education sessions, is (registered nurse/midwife)
the format of sessions will be face-to-face at antenatal clinics.
the smartphone applications used is (whatsapp) Messenger; a cross-platform mobile messaging app which allows to exchange messages without having to pay for SMS. WhatsApp users can create groups, send each other unlimited images, video and audio media messages.
strategies used to monitor adherence will be by checking attendance at education sessions.

the orientation round of the maternity ward for the intervention group will involves visiting admission room, labour room, and post-partum ward ; brief explanation about equipment, procedures, who will provide care for the mother at each room. brief explanation about the the routine care at maternity ward will be provided for the mothers.
the researcher will take the mother for orientation round immediately following enrollment approximately for ten minutes duration.
Intervention code [1] 295387 0
Behaviour
Comparator / control treatment
Women who allocated to the control group will receive usual antenatal 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.
Control group
Active

Outcomes
Primary outcome [1] 298950 0
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).

Timepoint [1] 298950 0
32- 37 weeks gestation for pre-test and three weeks later for post-test
Primary outcome [2] 299039 0
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).
Timepoint [2] 299039 0
32- 37 weeks gestation for pre-test and three weeks later for post-test
Secondary outcome [1] 325744 0
Length of first stage: --------------------hrs. (assessed by review of medical records).
Timepoint [1] 325744 0
24 -48 hrs post delivery
Secondary outcome [2] 327161 0
Type of delivery: (assessed by review of medical records).
? Vaginally ? Caesarean section ? Instrumental birth
Timepoint [2] 327161 0
24- 48 after delivery
Secondary outcome [3] 327162 0
Labour onset is: (assessed by review of medical records).
? spontaneous ? induced
Timepoint [3] 327162 0
24- 48 after delivery
Secondary outcome [4] 327163 0
Type of cesarean section is: (assessed by review of medical records).
? elective ? urgent
Timepoint [4] 327163 0
24- 48 after delivery
Secondary outcome [5] 327164 0
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……….
Timepoint [5] 327164 0
24- 48 after delivery
Secondary outcome [6] 327165 0
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
Timepoint [6] 327165 0
24- 48 after delivery
Secondary outcome [7] 327166 0
Did the woman need any electronic fetal heart rate monitoring? (assessed by review of medical records).
? No ? Yes
Timepoint [7] 327166 0
24- 48 after delivery
Secondary outcome [8] 327167 0
Did the women need Episiotomy? (assessed by review of medical records). ? No ? Yes
Timepoint [8] 327167 0
24- 48 after delivery
Secondary outcome [9] 327169 0
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
Timepoint [9] 327169 0
24- 48 after delivery
Secondary outcome [10] 327170 0
Did the mother experience any Post-partum hemorrhage? (assessed by review of medical records).
?None ? Primary ? Secondary
Timepoint [10] 327170 0
24- 48 after delivery
Secondary outcome [11] 327171 0
Length of hospital stay: ………………….hrs. (assessed by review of medical records).
Timepoint [11] 327171 0
24- 48 after delivery
Secondary outcome [12] 327172 0
Post natal medications: (assessed by review of medical records).
? Pain killer (injectable) ? Pain killer (tablet) ? Antibiotic(injectable)
? Antibiotic (tablet) ? other…………
Timepoint [12] 327172 0
24- 48 after delivery
Secondary outcome [13] 327173 0
Baby Birth weight: ……………………Kg. (assessed by review of medical records).
Timepoint [13] 327173 0
24- 48 after delivery
Secondary outcome [14] 327174 0
Gestational age: ………………………weeks.
(assessed by review of medical records).
Timepoint [14] 327174 0
24- 48 after delivery
Secondary outcome [15] 327175 0
Baby a live: ? No ? Yes
(assessed by review of medical records).
Timepoint [15] 327175 0
24- 48 after delivery
Secondary outcome [16] 327176 0
Baby is : ? Boy ? Girl
(assessed by review of medical records).
Timepoint [16] 327176 0
24- 48 after delivery
Secondary outcome [17] 327177 0
Apgar score at 1st minute………………
(assessed by review of medical records).
Timepoint [17] 327177 0
24- 48 after delivery
Secondary outcome [18] 327178 0
Apgar score at 5 minutes………………(assessed by review of medical records).
Timepoint [18] 327178 0
24- 48 after delivery
Secondary outcome [19] 327179 0
Does the baby need any assisted newborn ventilation? ? No ? Yes
(assessed by review of medical records).
Timepoint [19] 327179 0
24- 48 after delivery
Secondary outcome [20] 327180 0
Birth trauma: (assessed by review of medical records).
? Bruising ? Cephalohaematoma ? Facial Palsy ? Scalp injury
? Erbs Palsy ? Cerebral Palsy ? other……….
Timepoint [20] 327180 0
24- 48 after delivery
Secondary outcome [21] 327181 0
Onset of breast feeding ……………………hrs.
(assessed by review of medical records).
Timepoint [21] 327181 0
24- 48 after delivery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
high risk pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
pretest-posttest
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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.
For nursing studies, utilizing a minimum power of 0.80 enables the study to detect differences or relationships that exist in the population (Polit & Beck, 2011). Based on power analysis for calculation of sample size, in order to compare between the mean of the two groups by using independent t- test with anticipated significance at .05 level (alpha = .05), and the power level at .80 with a medium effect size (Cohen, 1992), the minimum required total sample size is 128 subjects, and sample size for each group is 64 subjects. For this study, the researcher will use the consecutive sampling technique to recruit participants in this study. Then, the women will be randomly assigned into two groups by using the random assignment sampling; each participant will be given a number from 1 to 128 and by using the Google randomizer software which is a computer program that generates two sets of 64 unique numbers per set range from 1 to 128. Participants who carry a number from interventional set will be placed in an intervention group and participants who carry a number from control set will be placed in a control group.
> Control group set
122, 61, 20, 57, 29, 65, 97, 3, 45, 62, 69, 117, 8, 93, 12,80, 25, 23, 94, 32, 2, 123, 104, 84, 92, 66, 7, 105, 119, 68, 103, 88, 28, 112, 113, 41, 67, 42, 43, 82, 5, 26, 21, 24, 36, 109, 127, 53, 116, 102, 50, 35, 87, 4, 58, 98, 75, 100, 71, 64, 121, 49, 72, 48
> intervention group set
86, 39, 82, 28, 124, 19, 51, 66, 85, 15, 99, 16, 30, 87, 100, 117, 14, 17, 101, 76, 3, 102, 40, 23, 1, 75, 108, 92, 43, 26, 69, 53, 80, 58, 120, 116, 103, 56, 115, 74, 22, 94, 57, 122, 29, 84, 93, 13, 2, 126, 61, 114, 118, 47, 50, 45, 25, 89, 5, 77, 6, 90, 36, 48
Thus, the full procedure will result in 64 participants in each of the control and intervention groups.
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 women who are planned to deliver at king Hussien medical center will be recruited.
Statistical analysis will be carried using the SPSS statistical software package (Windows version 22, SPSS Inc., Chicago, IL, USA). Demographic data and clinical characteristics will be summarized as the mean and standard deviation for continuous variables and as frequency counts (percentages) for categorical variables. Chi square ( ) test will be used to examine differences between the two groups for categorical data; analysis of covariance (ANCOVA) and independent 2-sample t-tests will be conducted for data at the ratio level of measurement to analyze group differences. All the proposed analyses methods in this study will be conducted by intention to treat and test the hypotheses, and will be performed at the 0.05 significance level.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment outside Australia
Country [1] 8028 0
Jordan
State/province [1] 8028 0
Amman

Funding & Sponsors
Funding source category [1] 294131 0
Self funded/Unfunded
Name [1] 294131 0
asma' abuabed
Country [1] 294131 0
Jordan
Primary sponsor type
University
Name
Jordan university of science and technology
Address
Address: Ar Ramtha, Irbid
PO Box (22110)
street (amman-alramtha street)
Jordan university of science and technology
Country
Jordan
Secondary sponsor category [1] 292962 0
Individual
Name [1] 292962 0
Dr Reem hatamleh
Address [1] 292962 0
Address: Ar Ramtha, Irbid
PO Box (22110)
street (amman-alramtha street)
Jordan university of science and technology
Country [1] 292962 0
Jordan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295482 0
Jordan University of science and technology Institutional Review Board (IRB).
Ethics committee address [1] 295482 0
Ethics committee country [1] 295482 0
Jordan
Date submitted for ethics approval [1] 295482 0
22/04/2016
Approval date [1] 295482 0
31/05/2016
Ethics approval number [1] 295482 0
none
Ethics committee name [2] 295538 0
jordanian royal medical services ethics commitee
Ethics committee address [2] 295538 0
Ethics committee country [2] 295538 0
Jordan
Date submitted for ethics approval [2] 295538 0
05/06/2016
Approval date [2] 295538 0
20/07/2016
Ethics approval number [2] 295538 0
none

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67438 0
Miss asma' shaker
Address 67438 0
Address: King Hussein Medical Center, King Abdullah II St 230, 11855
Country 67438 0
Jordan
Phone 67438 0
+962776400742
Fax 67438 0
none
Email 67438 0
[email protected]
Contact person for public queries
Name 67439 0
reem hatamleh
Address 67439 0
Address: Ar Ramtha, Irbid
PO Box (22110)
street (amman-alramtha street)
Jordan university of science and technology
Country 67439 0
Jordan
Phone 67439 0
+962791494011
Fax 67439 0
none
Email 67439 0
[email protected]
Contact person for scientific queries
Name 67440 0
sana' abujilban
Address 67440 0
Address: Jordan ,Zarqa, Abdallah Ghosheh, Az-Zarqa
royal medical services
P.O. Box 330127, Zarqa 13133, Jordan
Country 67440 0
Jordan
Phone 67440 0
+962799967184
Fax 67440 0
none
Email 67440 0
[email protected]

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No Supporting Document Provided



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