18 Years and OlderWHO-ICARE TriaNCT07451691
The Effect of the World Health Organisation-Based Intrapartum Care Model on Labour Pain, Comfort, Satisfaction and Postpartum Depression
A study testing WHO-ICARE Trial in people with 18 Years and Older and Term Pregnancy, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 18 Years and Older, Term Pregnancy
- What is being tested?
- WHO-ICARE Trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Mar 2026to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 years and older
- Gestational status: Term pregnancy
Who cannot join
- those with psychological problems
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Kahramanmaraş Sütçü İmama Universty
Kahramanmaraş, Kahramanmaraş, 46040
HATİCE GÜL GÜL ÖZTAŞ, 0542826762, haticeguloztas@ksu.edu.tr
Kahramanmaraş Sütçü İmama Universty
Kahramanmaraş, Kahramanmaraş, 461000
Hatice Gül GÜL OZTAS, 0542826762, h.gul_akbaba@hotmail.com.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- 18 Years and Older, Term Pregnancy
- Being tested
- WHO-ICARE Trial
- Keywords
- Labor Pain, Childbirth, Normal Vaginal, Maternal Comfort
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO-ICARE TrialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60-120 minutes
Secondary outcomes (2)
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
Measured: 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
Measured: 60 minuteShort Form of the Birth Satisfaction Scale (DMÖ-K)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 18 Years and OlderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Gul OZTAS, Kahramanmaras Sutcu Imam University
- Investigators
- HATİCE GÜL ÖZTAŞ, Study director, Kahramanmaraş sütçü imam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451691
- Sponsor's protocol ID
- KahramanmaraşSIUI11
- Acronym
- WHO-ICARE Tria
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the World Health Organisation-Based Intrapartum Care Model on Labour Pain, Comfort, Satisfaction and Postpartum Depression: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07451691
- Acronym / sponsor ID
- WHO-ICARE Tria / KahramanmaraşSIUI11
- Conditions
- 18 Years and Older, Term Pregnancy
- Keywords
- Labor Pain, Childbirth, Normal Vaginal, Maternal Comfort
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental- WHO-ICARE Trial | Experimental | Behavioral: WHO-ICARE TrialParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18 years and older
- Gestational status: Term pregnancy
Key exclusion criteria (1 listed)
- those with psychological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO-ICARE TrialParticipants 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. | Behavioural | Experimental- WHO-ICARE Trial |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 60-120 minutes
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
2 secondary outcomes
Birth Comfort Scale (BCS)
Time frame: 60-120 minute
Birth Satisfaction Scale - Short Form (BSS-S)
Time frame: 60 minuteShort Form of the Birth Satisfaction Scale (DMÖ-K)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HATİCE GÜL ÖZTAŞ study director
Kahramanmaraş sütçü imam
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO-ICARE Trial in people with 18 Years and Older and Term Pregnancy, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HATİCE GÜL ÖZTAŞ, DİRECTOR (+900542826762, haticeguloztas@ksu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 60-120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.