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

NCT07451691 | Not Yet Recruiting

• 1 other identifier: KahramanmaraşSIUI11
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

18 Years and Older; Term Pregnancy

Keywords

Labor Pain; Childbirth; Normal Vaginal; Maternal Comfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Birth Comfort Scale (BCS)

  60-120 minute

• Birth Satisfaction Scale - Short Form (BSS-S)

  60 minuteShort Form of the Birth Satisfaction Scale (DMÖ-K)

Study Arms (2)

Experimental- WHO-ICARE Trial

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

WHO-ICARE Trial BEHAVIORAL

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.

Experimental- WHO-ICARE Trial

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 years and older
• Gestational status: Term pregnancy

You may not qualify if:

• those with psychological problems

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Kahramanmaraş Sütçü İmama Universty

Kahramanmaraş, Kahramanmaraş, 46040, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü İmama Universty

Kahramanmaraş, Kahramanmaraş, 461000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• HATİCE GÜL ÖZTAŞ

  Kahramanmaraş sütçü imam

  STUDY DIRECTOR

Central Study Contacts

HATİCE GÜL ÖZTAŞ, DİRECTOR

CONTACT

+900542826762; haticeguloztas@ksu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 5, 2026
• Study Start: March 5, 2026
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)