Design and setting
A validation study was carried out to translate and validate the CEQ from English to Sinhala at Ward 25 of University Unit of Obstetrics and Gynaecology, North Colombo Teaching Hospital (NCTH), Ragama, Sri Lanka, from February 2017 to January 2018. The original English language CEQ was translated into Sinhala language according to the standard validation protocols before its final validation study as recommended by the World Health Organization (WHO) 13.
Study population and sample size
Mothers who have undergone their first labour and childbirth experience in last 24-48 hours during the study period was invited to participate in the study. Subjects to control ratio of 1:1 was taken using known-groups validation. Subjects were women who were nulliparous and undergoing operative deliveries (forceps deliveries, vacuum deliveries, emergency caesarean deliveries). Controls were women who were nulliparous and undergoing normal deliveries. According to the accepted method of 10 times the observed variables (subject to variable ratio of 10:1) minimum sample size of 220 with 22 items was taken 1,14. CEQ has 22 items in four domains. As mentioned above those are: own capacity, professional support, perceived safety and communication. A 70% response rate was reported in the Swedish original CEQ development and validation study 1. Therefore, it was decided to recruit a sample of postpartum women until the final minimum sample of 220 postpartum women (with completed questionnaires) have been responded depending on our response rate. Convenience sampling method was adopted.
Inclusion and exclusion criteria
- Pregnant women who were more than 16 years of age and mothers who have undergone their first labour and childbirth experience in last 24-48 hours.
- Women with a single live fetus and who were labouring at term (including women who were having a caesarean delivery in their latent phase of labour and also women with failed induction of labour).
- Women who were sending from labour room and undergoing emergency cesarean deliveries in last 24-48 hours were also included.
- Women who were having a baby who was not alive anymore or women with their babies were getting admitted to a special baby unit (e.g. Neonatal Special Care Baby Unit or Intensive Care Unit).
- Patients who were not willing to participate, who could not read or write in Sinhala language were excluded from the study.
- Women who were undergoing planned elective cesarean deliveries.
- Women who were not educated up to G.C.E. Ordinary Level were also excluded.
The linguistic translation process was carried out involving following basic steps 15. Literal translation (forward translation) and adaptation of the English questionnaire into Sinhala lifestyle and cultural context were undertaken by two accredited bilingual native Sinhala speakers. One of them was a woman in reproductive age. After receiving the both Sinhala translations, our research group at Ragama, compared them. Discussion with obstetricians, labour room staff and patients as to whether the questionnaire measures what it was designed to measure and that clinically meaningful aspects were not lacking. With their comments, the Sinhala version of questionnaire was revised and rephrased according to Sri Lankan cultural and language context and compiled them into one Sinhala language version. It was also reviewed by the above accredited translators. Back-translation from Sinhala to English was performed by a single accredited translator who was also a bilingual native speaker. Then, review of the back-translation was carried out by the CEQ team at the Sahlgrenska Academy, University of Gothenburg, Sweden. The final Sinhala CEQ translation was produced after modifications, re-translation of necessary items to balance the discrepancies during translation process. Validation study was carried out using this final translation. During the literal translation we asked from the translators to give us options if there are different ways to translate any of the items and/or there are difficulties in the translation process.
Sinhala version of the CEQ was used as the study instrument. The CEQ consists of 22 items referring to the childbirth experience (Table 2). Women’s responses to 19 items in CEQ were rated on a 4-point Likert scale and remaining 3 items were evaluated by means of a visual analogue scale (VAS). These VAS scores are then converted into categorical variables facilitating interpretation and analysis; 0–40 = 1, 41–60 = 2, 61–80 = 3 and 81–100 = 4. As mentioned in Table 2, negatively worded items were reversed. All 22 items in CEQ are divided into 4 groups as 4 main domains as mentioned above; “own capacity” (8 items about sense of control, their feelings during birth process and labour pain; 1,2,4,5,6,19,20,21 items), “professional support” (5 items regarding information and the midwifery care they received; 13,14,15,16,17 items), “perceived safety” (6 items about sense of security and memories from their labour and childbirth; 3,7,8,9,18,22 items), and “participation” (3 items about own possibilities to influence maternal position, their movements and pain relief in labour; 10,11,12 items).
Data collection procedure
Eligible women were identified in the postnatal ward by the investigator and were invited to participate. They were given the information sheets and consent forms. Those who agreed to join recruited by signing an informed written consent form. Women were received a clear description of the procedure by the investigator. Initially basic demographic and clinical details were collected into a data collection sheet.
Two copies of CEQ with two stamped-envelopes were given to each mother and were asked to fill each in one moth postnatal and six weeks postnatal. Soon after childbirth, mothers were supposed to have gone through their first labour experience and having relatively fresh memories of their childbirth experience. As well as, mothers have minimum contact with their childbirth caregivers at hospital after four weeks. Therefore chances of giving socially desirable responses were minimal and minimizing potential bias. Recruited women were offered the option of completing the CEQ at home and sending it via post and also to ask for clarifications by making a phone call to the investigator. Reminders were sent after one moth and six weeks as a phone call or a post card. Demographic details and their delivery details were collected from the clinical notes.
Basic demographic characteristics of the data was analysed to see any deviations. Continuous variables were presented as means and standard deviations. Pearson Chi-Square test was applied to any difference between categorical variables. Mann- Whitney U test was applied to compare any skewed continuous variables. P value < 0.05 was considered as statistically significant.
Face validity was done for the Sinhala CEQ version to see the items were well understood and easy to answer to. This was done by giving questionnaire to 25 primiparous mothers to find any difficult questions and asking their comments on questionnaire items. The CEQ was also given to a group of labour ward staff members at NCTH (n=10) consisting of three experienced nurse-midwives, three midwives and one medical officer who was also a female in reproductive age group.
This was evaluated using Cronbach’s coefficient alpha. Usually, Cronbach’s alpha ≥ 0.7 is considered as a satisfactory level of internal consistency.
Construct validity was evaluated as follows. The first was whether the questionnaire was able to differentiate between complicated (operative) and uncomplicated (normal delivery) deliveries, and secondly to test questionnaire against the delivery outcome. The method of known-groups validation was used to measure construct validity. This method can be used to evaluate the ability of the CEQ to distinguish between above known groups within the sample and which were known to differ on known key socio-demographic or clinical variables. The CEQ has shown good construct validity and reliability for assessing childbirth experience between its known groups 1.
A comparison was done between CEQ subscale scores and overall CEQ score for different key characteristics.
- Women who had labour onset; spontaneous versus induced
- Women with duration of labour; more than 12 hours versus less than 12 hours
- Women with augmentation of labour; with oxytocin versus without oxytocin
- Women who had a; normal delivery versus operative delivery.
Here the overall CEQ score means average of the 4 individual CEQ subscale scores. It is well-documented that oxytocin augmentation of labour with oxytocin, operative delivery (instrumental or caesarean delivery) and long duration of labour (> 12 hours) known to cause a negative influence on woman’s childbirth experience 16,17,18.
Since the subscale scores were not normally distributed, non-parametric Mann-Whitney U test was applied to compare subscale scores between subgroups.
To assess stability (test-retest reliability) a two-week test-retest analysis of the sample was done. This agreement was further assessed by using the weighted Kappa (k) statistic 19. To represent a substantial agreement between the two scores between one month and six weeks questionnaires a value of weighted Kappa between 0.61 – 0.80 was taken 20.
Eligible patients were identified and counseled by investigator at the study setting. Before entry into the study the investigator explained each patient the objectives, methods as well as potential benefits and risks of participating in the study. Patient information sheets were distributed to eligible patients. After sufficient information, informed written consent was obtained.
We have also taken written permission from the original authors of CEQ, Dencker et.al in the CEQ team at the Sahlgrenska Academy, University of Gothenburg, Sweden.
Ethical aspects of this study were reviewed and approved by the Ethical Review Committee, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.