About this trial
This randomized controlled trial aims to evaluate the effects of the World Health Organization-based intrapartum care model on labour pain, labour comfort, childbirth satisfaction, and postpartum depression. The intrapartum care model emphasizes woman-centred, respectful, and supportive care throughout labour, promoting continuous support, effective communication, and active involvement of women in decision-making processes. Although this approach has been associated with improved labour experiences, including reduced pain, increased comfort and satisfaction, evidence from randomized controlled trials evaluating these outcomes together with postpartum depression in a comprehensive framework remains limited. This study seeks to provide high-quality evidence on the impact of the intrapartum care model on maternal childbirth experience and postpartum mental health.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 18 years and older
Disqualifiers
those with psychological problems
Trial design
Parallel
Treatments tested in this trial
WHO-ICARE Trial
BehavioralParticipants in the intervention group will receive continuous, individualized, and woman-centred midwifery care based on the World Health Organization intrapartum care model throughout labour and childbirth. This intervention includes continuous physical and emotional support, effective communication, provision of timely information, encouragement of shared decision-making, respect for privacy and dignity, and avoidance of unnecessary medical interventions. Supportive care will be provided consistently from admission to the labour ward until the completion of childbirth.
Treatment groups
Trial outcomes
Primary outcomes
Visual Analog Scale (VAS)
Pain intensity was assessed using the Visual Analog Scale (VAS), a unidimensional pain measurement tool originally described by Price et al. (1983). The VAS consists of a 10-cm horizontal line, with the left endpoint labeled "0 = no pain" and the right endpoint labeled "10 = unbearable pain." Participants were asked to mark a point on the line that best represented the intensity of pain they perceived at that moment. The distance in centimeters from the "0" point to the marked point was measured and recorded as the pain intensity score. The scale ranges from 0 to 10, where higher scores indicate greater pain intensity (worse outcome). Pain severity was interpreted as follows: 0 = no pain, 2 = mild pain, 4 = moderate pain, 6 = severe pain, 8 = very severe pain, and 10 = unbearable pain. In this study, the Visual Analog Scale was administered at two time points: first, during the pregnant woman's initial admission to the maternity clinic in the latent phase
Secondary outcomes
Birth Comfort Scale (BCS)
Maternal comfort during labor was assessed using the Birth Comfort Scale (BCS), a multidimensional instrument developed based on Kolcaba's Comfort Theory to evaluate women's comfort levels during childbirth. The original version of the scale consists of 14 items rated on a five-point Likert scale (Schuiling et al., 2011). Following the Turkish validity and reliability study, the scale was reduced to 9 items with a three-factor structure (Environmental, Physical, and Psychospiritual dimensions) and demonstrated acceptable internal consistency (Cronbach's alpha = 0.75) (Potur et al., 2015). Each item is scored from 1 to 5, resulting in a total score ranging from 9 to 45, with higher total scores indicating greater birth comfort (better outcome). Items 5, 7, and 8 are reverse-coded when calculating the total score. In this study, the Birth Comfort Scale was administered at two time points: first, during the pregnant woman's initial admission to the clinic in
Birth Satisfaction Scale - Short Form (BSS-S)
Women's satisfaction with the childbirth experience was assessed using the Birth Satisfaction Scale - Short Form (BSS-S), a 10-item abbreviated version of the original 30-item Birth Satisfaction Scale developed by Hollins Martin and Fleming (2011) and later revised by Hollins Martin and Martin (2014). The Turkish validity and reliability study of the scale was conducted by Göncü and Karahan (2015). The BSS-S is a five-point Likert-type scale, with response options ranging from "Strongly Disagree" (0 points) to "Strongly Agree" (4 points). The total score ranges from 0 to 40, with higher total scores indicating greater birth satisfaction (better outcome). Items 2, 4, 7, and 8 are reverse-scored when calculating the total score. In the Turkish version of the scale, no formal cut-off score was established. Instead, the total score was divided into three equal categories to classify satisfaction levels as follows: low satisfaction (\<13 poin
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