2. Materials and Methods
mental illness, Anxiety, anxiety, birth companions, VAS-A, humor
SECONDARY
A cross-sectional stepped wedge cluster randomized trial was used. In this design, different individuals in the control and intervention are used with a single observation of outcomes [The study was carried out in the Bugisu sub-region located in the eastern part of Uganda. The Bugisu sub-region consists of six districts, including Manafwa, Mbale, Bududa, Sironko, Namisindwa, and Bulambuli. According to the Uganda National Bureau of Statistics, the sub-region is home mainly to the Gisu people with an average household size of 4.8 and a literacy rate of 51.5% [Cluster sampling: Each health facility in this context was considered a cluster. The inclusion criteria were the functionality of an operating theatre. Hospitals and HCIVs with a functional operating theatre were included. It was assumed that the presence of a functional theatre meant that the chances of referring women for cesarean sections to other facilities were small, enabling us to monitor more deliveries. Four clusters were selected for this trial. These were Mbale Regional Referral Hospital, Bududa, district hospital, Muyembe HCIV, and Busiu (Manafwa) HCIV.Individual specific criteria. Women who had a birth companion, in spontaneously established labor and, expecting a vaginal delivery. Exclusion criteria were women with multiple pregnancies, previous cesarean section, and mental illness, or deaf or mute women. We excluded women who had previous cesarean sections because they had a higher chance of having another cesarean section.Intervention: The intervention was “midwife-provided orientation of birth companions”. The admitting midwife provided an orientation session for the birth companion on supportive labor techniques. We assumed that providing an orientation session was likely to boost birth companion confidence, hence increasing the effectiveness of continuous support. The content for the orientation session consisted of providing emotional and physical support. Emotional support included being present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, and praise, and encouraging and acknowledging efforts. Physical support included supporting her to change positions favoring upright positions, walking with her, giving her drinks and food, massaging, reminding her to go and pass urine, helping her find a comfortable position for pushing, and wiping her face with a cool cloth. The content was developed based on the literature on labor companionship techniques [Control (usual care): Women are escorted to the health facilities by one or more family members or friends. One person is allowed, besides her, to provide support. The support persons do not receive any orientation sessions and have no designated roles. Routine analgesia is not given. Midwives, medical officers, and obstetricians provide skilled care. Typically, two to three midwives are allocated per 8-h shift managing about six laboring women at a given time.Outcomes: This article is a part of a larger study assessing the effectiveness of midwife-provided orientation of birth companions on several outcomes. These were the incidence of having a spontaneous vaginal delivery, length of labor, Apgar score, coping, anxiety, and maternal satisfaction. The primary outcome was the chance of having a spontaneous vaginal delivery. This article is a reporting on two of the secondary outcomes of the actual trial. The rationale for reporting maternal anxiety and coping separately was to give more attention to the psychological aspects of childbirth. Psychological research on childbirth is scarce [Sample size and randomization: Stepped wedge trials are designed to study the effect of an intervention [Randomization for stepped wedge trials is not performed individually but rather involves the crossover of clusters from control to intervention until all clusters are exposed [Women’s self-reported anxiety levels were measured within 6 h after birth using the 10 cm Visual Analogue Scale for Anxiety (VAS-A). It ranges from 0 to 10, with a higher score representing high levels of anxiety. The VAS-A has demonstrated validity and reliability for measuring anxiety and has been used in several studies to assess anxiety in similar low-resource settings [Analysis: In this study design, the distribution of results across control periods is compared with that across the intervention periods [