The Effect of the World Health Organisation-Based Intrapartum Care Model on Labour Pain, Comfort, Satisfaction and Postpartum Depression (WHO-ICARE Tria)

The Effect of the World Health Organisation-Based Intrapartum Care Model on Labour Pain, Comfort, Satisfaction and Postpartum Depression: A Randomised Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Term Pregnancy; 18 Years and Older
• Intervention / Treatment: Behavioral: WHO-ICARE Trial

Detailed Description

Approximately 140 million births occur worldwide each year, most of which arise from pregnancies without initial risk to the mother or the newborn. Nevertheless, labour represents a critical period for maternal and neonatal survival, as complications that may develop during this process can substantially increase morbidity and mortality risks. Therefore, the quality of care provided during childbirth is of vital importance. Continuous, woman-centred support during labour is closely associated with positive childbirth experiences.

Negative experiences encountered by women in health facilities during childbirth may render the birth experience distressing, and disrespectful or abusive attitudes from care providers can further exacerbate this situation. A positive childbirth experience is largely related to the extent to which women's expectations and preferences are met, while discrepancies between expectations and experiences may result in childbirth dissatisfaction. Moreover, negative childbirth experiences increase the risk of postpartum depression, anxiety, and post-traumatic stress symptoms. Postpartum depression is a common mental health problem among women after childbirth and adversely affects mother-infant bonding, breastfeeding, and family relationships. In this context, respectful and supportive care during labour is considered to have a protective effect against postpartum depression.

Although various interventions have been developed to support positive childbirth experiences, a standardized childbirth care model has not yet been fully established. In response to this need, the World Health Organization introduced the intrapartum care model in 2018, emphasizing woman-centred, respectful, and supportive care. This model conceptualizes childbirth not only as a physiological process but also as an experience in which women's rights and dignity must be preserved. The intrapartum care model prioritizes respect for women's rights, effective communication, continuous support, avoidance of unnecessary interventions, and the optimization of maternal and neonatal health and comfort.

The intrapartum care model aims to provide individualized and supportive care, promoting continuous communication and shared decision-making throughout labour. Evidence suggests that this approach reduces labour pain, enhances comfort, improves maternal and neonatal outcomes, and positively influences childbirth experiences, thereby supporting postpartum psychological well-being. Childbirth satisfaction, which reflects the degree to which women's expectations and needs are met, is a key indicator of childbirth quality. Additionally, labour pain is a critical factor directly influencing childbirth experience, with supportive care being associated with lower perceived pain and higher levels of comfort.

Despite existing studies examining the effects of intrapartum care practices on labour pain, comfort, or satisfaction individually, randomized controlled trials evaluating these outcomes together with postpartum depression within a comprehensive framework remain limited. Furthermore, high-quality evidence assessing the effects of the World Health Organization-recommended intrapartum care model on childbirth experience and postpartum mental health is insufficient. Therefore, 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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HATİCE GÜL ÖZTAŞ, DİRECTOR; Phone Number: +900542826762; Email: haticeguloztas@ksu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Kahramanmaraş
    • Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 46040
      • Kahramanmaraş Sütçü İmama Universty
      • Contact: HATİCE GÜL GÜL ÖZTAŞ; Phone Number: 0542826762; Email: haticeguloztas@ksu.edu.tr
    • Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 461000
      • Kahramanmaraş Sütçü İmama Universty
      • Contact: Hatice Gül GÜL OZTAS; Phone Number: 0542826762; Email: h.gul_akbaba@hotmail.com.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age: 18 years and older

Gestational status: Term pregnancy

Exclusion Criteria:

• those with psychological problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental- WHO-ICARE Trial; Participants 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.	Behavioral: WHO-ICARE Trial; Participants 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.
No Intervention: control group; Participants in the control group will receive routine intrapartum care provided in the hospital in accordance with standard clinical practice. This care includes standard midwifery and obstetric services without the structured implementation of the World Health Organization-based intrapartum care model or continuous individualized supportive care. No additional intervention beyond routine care will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	60-120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	60-120 minute
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	60 minuteShort Form of the Birth Satisfaction Scale (DMÖ-K)

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University
• Investigators: Study Director: HATİCE GÜL ÖZTAŞ, Kahramanmaraş sütçü imam

Study record dates

Study Major Dates

• Study Start (Estimated): March 5, 2026
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Childbirth; Labor Pain; Maternal Comfort; Normal Vaginal
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain
• Other Study ID Numbers: KahramanmaraşSIUI11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No