Pregnancy-Related Anxiety (PrA)PCYCARE-RCTNCT07229989
Pregnancy Care Digital Intervention for Maternal Anxiety in the Third Trimester (PCYCARE-RCT)
A study testing PCYCARE Digital Self-Care Program and Routine Antenatal Care in people with Pregnancy-Related Anxiety (PrA) and Anxiety, run by Lincoln University College Malaysia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to evaluate whether a digital self-care intervention (PCYCARE) can reduce pregnancy-related anxiety and improve biopsychosocial adaptation among third-trimester pregnant women. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pregnancy-Related Anxiety (PrA), Anxiety
- What is being tested?
- PCYCARE Digital Self-Care Program and Routine Antenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 20-35 years
- Gestational age between 28 and 35 weeks (third trimester)
- Primigravida
- Able to read and understand the language used in the PCYCARE platform
- Owns a smartphone or digital device with internet access
- Willing to participate and provide informed consent
Who cannot join
- High-risk pregnancy requiring intensive medical care
- Severe psychiatric or cognitive disorders that may interfere with participation
- Participation in another intervention or educational program that may affect study outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Pregnancy Care Digital Self-Care Intervention on Maternal Anxiety in the Third Trimester Within a Biopsychosocial Adaptation Framework: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether a digital self-care intervention (PCYCARE) can reduce pregnancy-related anxiety and improve biopsychosocial adaptation among third-trimester pregnant women.
The main questions it aims to answer are:
Read more
- Does the PCYCARE digital program reduce pregnancy-related anxiety in third-trimester pregnant women?
- Does the intervention improve maternal knowledge, childbirth preparedness, and sleep quality?
Researchers will compare participants who receive the PCYCARE digital program with those who receive routine antenatal care to determine the effectiveness of the intervention.
Participants will:
- Use the PCYCARE mobile-based program for 21 days, which includes educational modules and guided audio relaxation sessions
- Complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes
- Complete questionnaires at baseline and after the intervention to assess anxiety, sleep quality, maternal knowledge, and childbirth preparedness
Read the detailed description
Background:
Pregnancy-related anxiety is a common psychological condition during the third trimester and is associated with adverse maternal and neonatal outcomes, including preterm birth, shortened gestation, and impaired maternal-infant adaptation. Unlike generalized anxiety, pregnancy-related anxiety reflects condition-specific concerns related to fetal health, childbirth, and readiness for motherhood. Emerging evidence indicates that pregnancy-related anxiety is influenced by interconnected cognitive, psychosocial, and physiological mechanisms. Maternal knowledge contributes to cognitive appraisal and perceived control, childbirth preparedness reflects psychosocial readiness, and sleep quality represents a key physiological regulator of emotional stability. These domains interact dynamically, suggesting that pregnancy-related anxiety can be understood as a biopsychosocial adaptation process. Despite increasing use of digital health interventions in maternal care, many existing applications focus on single outcomes and lack theoretical integration across these domains. Therefore, there is a need for structured digital interventions that simultaneously address cognitive, psychosocial, and physiological pathways.
Intervention Overview:
This study evaluates PCYCARE, a digital self-care program designed to support integrated maternal adaptation during late pregnancy. The intervention consists of:
- educational modules aimed at improving maternal knowledge and childbirth preparedness (cognitive and psychosocial domains), and
- guided audio relaxation sessions aimed at supporting emotional regulation and improving sleep quality (physiological domain).
Participants are instructed to complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes, over a 21-day intervention period.
Study Objectives:
The primary objective of this study is to evaluate the effectiveness of the PCYCARE digital intervention in reducing pregnancy-related anxiety among third-trimester pregnant women.
Secondary objectives are to evaluate improvements in maternal knowledge, childbirth preparedness, and sleep quality, and to examine how these variables interact within a biopsychosocial adaptation model.
Study Design:
This study employs an individual randomized controlled trial (RCT) with a pretest-posttest design. Participants are randomly assigned in a 1:1 ratio to either the intervention group or the control group using stratified block randomization.
Study Population:
The study population consists of primigravida women in the third trimester of pregnancy (28-35 weeks of gestation) recruited from primary health centers.
Comparator:
Participants in the control group receive routine antenatal care without access to the PCYCARE digital intervention.
Outcomes and Biopsychosocial Model:
The study includes four key measured variables:
- Pregnancy-related anxiety (primary outcome)
- Sleep quality (secondary outcome; physiological domain)
- Maternal knowledge (secondary outcome; cognitive domain)
- Childbirth preparedness (secondary outcome; psychosocial domain)
All variables are measured at baseline and after the 21-day intervention using validated instruments.
This study is guided by a digital biopsychosocial adaptation model in which:
- Cognitive adaptation (maternal knowledge) enhances understanding and perceived control
- Psychosocial adaptation (childbirth preparedness) supports readiness and coping
- Physiological regulation (sleep quality) stabilizes emotional responses
Within this model, sleep quality is hypothesized to function as a central pathway linking cognitive and psychosocial improvements to reductions in pregnancy-related anxiety.
Significance:
This study provides evidence for a theory-driven digital self-care intervention that integrates cognitive, psychosocial, and physiological mechanisms. The findings are expected to inform scalable strategies for improving maternal mental health and childbirth preparedness, particularly in resource-limited settings.
- Conditions
- Pregnancy-Related Anxiety (PrA), Anxiety
- Being tested
- PCYCARE Digital Self-Care Program, Routine Antenatal Care
- Keywords
- pregnancy-related anxiety, digital self-care intervention, maternal knowledge, childbirth preparedness, sleep quality, biopsychosocial model, mobile health (mHealth)
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCYCARE Digital Self-Care ProgramBehavioural
Also called Pregnancy Care App, Digital Pregnancy Self-Care Intervention
PCYCARE is a mobile-based digital self-care intervention designed for third-trimester pregnant women. The program integrates two main components: (1) structured educational modules aimed at improving maternal knowledge and childbirth preparedness (cognitive and psychosocial domains), and (2) guided audio relaxation sessions designed to support emotional regulation and improve sleep quality (physiological domain). Participants are instructed to engage with the program twice daily for 21 days, completing both educational and relaxation sessions. Each session lasts approximately 10-15 minutes. The intervention is designed to support integrated biopsychosocial adaptation and reduce pregnancy-related anxiety.
Routine Antenatal CareOther
Participants receive routine antenatal care according to local clinical practice guidelines. Standard care includes regular antenatal check-ups, basic maternal health education, and routine monitoring of pregnancy. No additional digital self-care intervention or structured program is provided during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Arm Type: Experimental
Arm Name: PCYCARE Intervention Group
Description:
Participants in this group receive the PCYCARE digital self-care program for 21 days. The program consists of two components:
1. educational modules aimed at improving maternal knowledge and childbirth preparedness, and
2. guided audio relaxation sessions designed to support emotional regulation and improve sleep quality. Participants are instructed to complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes. Receives: Behavioral: PCYCARE Digital Self-Care Program |
| Routine Antenatal Care Group (control) | Active comparator | Arm Type: Active Comparator
Arm Name: Routine Antenatal Care Group
Description:
Participants in this group receive routine antenatal care without access to the PCYCARE digital intervention. Standard care includes regular antenatal check-ups, health education, and routine maternal monitoring according to local clinical guidelines. Receives: Other: Routine Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pregnancy-Related Anxiety
Pregnancy-related anxiety is assessed using the Late Pregnancy Anxiety Scale-Indonesian Version (LPAS-ID), an 8-item Likert-type scale. Each item is rated on a 4-point scale, with higher total scores indicating greater levels of anxiety. The outcome is defined as the change in total score from baseline to post-intervention.
Measured: Baseline and 21 days (post-intervention)
Secondary outcomes (3)
Change in Sleep Quality
Sleep quality is assessed using the Maternal Sleep Quality Index for the Third Trimester - Indonesian Version (MSQI-T3-ID), an 8-item self-report instrument. Higher total scores indicate poorer sleep quality. The outcome is defined as the change in total score from baseline to post-intervention.
Measured: Baseline and 21 days (post-intervention)
Change in Maternal Knowledge
Maternal knowledge is assessed using the Third Trimester Pregnancy Knowledge Questionnaire (TPKQ), a 10-item multiple-choice instrument. Each correct response is scored as 1 and incorrect responses as 0, with higher scores indicating greater knowledge. The outcome is defined as the change in total score from baseline to post-intervention.
Measured: Baseline and 21 days (post-intervention)
Change in Childbirth Preparedness
Childbirth preparedness is assessed using the Childbirth Readiness Questionnaire (CRQ), a 9-item Likert-type scale. Higher total scores indicate greater preparedness for childbirth. The outcome is defined as the change in total score from baseline to post-intervention.
Measured: Baseline and 21 days (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start18 Sep 2025
- Primary completion20 Sep 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy-Related Anxiety (PrA)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an individual randomized controlled trial (RCT) with a pretest-posttest design. Participants are randomly assigned in a 1:1 ratio using stratified block randomization into two parallel groups: an intervention group receiving the PCYCARE digital self-care program for 21 days, and a control group receiving routine antenatal care. The study evaluates the effectiveness of the intervention in improving maternal knowledge, childbirth preparedness, sleep quality, and reducing pregnancy-related anxiety.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lincoln University College Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurul Jannah, M.Tr.Keb, Lincoln University College Malaysia
- Investigators
- Nurul Jannah, M.Tr.Keb, Principal investigator, Lincoln University College Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229989
- Sponsor's protocol ID
- LUC_02_Jannah
- Other IDs
- LUC_02_Jannah
- Acronym
- PCYCARE-RCT
- Status last verified
- Apr 2026
- First submitted
- 29 Sep 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected during this study will not be shared with other researchers outside the study team. This decision is based on considerations of participant confidentiality, ethical approval limitations, and the scope of the current research. All data will be used solely for the purposes of this study and will remain under the control of the principal investigator and affiliated institution.
Publications
Jannah, N., & Selvarajh, G. (2026). Late-pregnancy anxiety as a distinct multidimensional construct: Psychometric evidence from a community-based sample. Science Midwifery, 13(6), 1562-1570
Jannah, N., Selvarajh, G., & Lestari, S. (2025). Feasibility and Acceptability of PcyCare: A Self-Directed Digital Platform for Maternal Health Literacy and Emotional Support. International Journal of Nursing Information, 4(2), 12-22.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Pregnancy Care Digital Self-Care Intervention on Maternal Anxiety in the Third Trimester Within a Biopsychosocial Adaptation Framework: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07229989
- Acronym / sponsor ID
- PCYCARE-RCT / LUC_02_Jannah
- Conditions
- Pregnancy-Related Anxiety (PrA), Anxiety
- Keywords
- pregnancy-related anxiety, digital self-care intervention, maternal knowledge, childbirth preparedness, sleep quality, biopsychosocial model, mobile health (mHealth)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lincoln University College MalaysiaUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 17 Nov 2025 (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.
The goal of this clinical trial is to evaluate whether a digital self-care intervention (PCYCARE) can reduce pregnancy-related anxiety and improve biopsychosocial adaptation among third-trimester pregnant women.
The main questions it aims to answer are:
- Does the PCYCARE digital program reduce pregnancy-related anxiety in third-trimester pregnant women?
- Does the intervention improve maternal knowledge, childbirth preparedness, and sleep quality?
Researchers will compare participants who receive the PCYCARE digital program with those who receive routine antenatal care to determine the effectiveness of the intervention.
Participants will:
- Use the PCYCARE mobile-based program for 21 days, which includes educational modules and guided audio relaxation sessions
- Complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes
- Complete questionnaires at baseline and after the intervention to assess anxiety, sleep quality, maternal knowledge, and childbirth preparedness
Detailed description
Background:
Pregnancy-related anxiety is a common psychological condition during the third trimester and is associated with adverse maternal and neonatal outcomes, including preterm birth, shortened gestation, and impaired maternal-infant adaptation. Unlike generalized anxiety, pregnancy-related anxiety reflects condition-specific concerns related to fetal health, childbirth, and readiness for motherhood. Emerging evidence indicates that pregnancy-related anxiety is influenced by interconnected cognitive, psychosocial, and physiological mechanisms. Maternal knowledge contributes to cognitive appraisal and perceived control, childbirth preparedness reflects psychosocial readiness, and sleep quality represents a key physiological regulator of emotional stability. These domains interact dynamically, suggesting that pregnancy-related anxiety can be understood as a biopsychosocial adaptation process. Despite increasing use of digital health interventions in maternal care, many existing applications focus on single outcomes and lack theoretical integration across these domains. Therefore, there is a need for structured digital interventions that simultaneously address cognitive, psychosocial, and physiological pathways.
Intervention Overview:
This study evaluates PCYCARE, a digital self-care program designed to support integrated maternal adaptation during late pregnancy. The intervention consists of:
- educational modules aimed at improving maternal knowledge and childbirth preparedness (cognitive and psychosocial domains), and
- guided audio relaxation sessions aimed at supporting emotional regulation and improving sleep quality (physiological domain).
Participants are instructed to complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes, over a 21-day intervention period.
Study Objectives:
The primary objective of this study is to evaluate the effectiveness of the PCYCARE digital intervention in reducing pregnancy-related anxiety among third-trimester pregnant women.
Secondary objectives are to evaluate improvements in maternal knowledge, childbirth preparedness, and sleep quality, and to examine how these variables interact within a biopsychosocial adaptation model.
Study Design:
This study employs an individual randomized controlled trial (RCT) with a pretest-posttest design. Participants are randomly assigned in a 1:1 ratio to either the intervention group or the control group using stratified block randomization.
Study Population:
The study population consists of primigravida women in the third trimester of pregnancy (28-35 weeks of gestation) recruited from primary health centers.
Comparator:
Participants in the control group receive routine antenatal care without access to the PCYCARE digital intervention.
Outcomes and Biopsychosocial Model:
The study includes four key measured variables:
- Pregnancy-related anxiety (primary outcome)
- Sleep quality (secondary outcome; physiological domain)
- Maternal knowledge (secondary outcome; cognitive domain)
- Childbirth preparedness (secondary outcome; psychosocial domain)
All variables are measured at baseline and after the 21-day intervention using validated instruments.
This study is guided by a digital biopsychosocial adaptation model in which:
- Cognitive adaptation (maternal knowledge) enhances understanding and perceived control
- Psychosocial adaptation (childbirth preparedness) supports readiness and coping
- Physiological regulation (sleep quality) stabilizes emotional responses
Within this model, sleep quality is hypothesized to function as a central pathway linking cognitive and psychosocial improvements to reductions in pregnancy-related anxiety.
Significance:
This study provides evidence for a theory-driven digital self-care intervention that integrates cognitive, psychosocial, and physiological mechanisms. The findings are expected to inform scalable strategies for improving maternal mental health and childbirth preparedness, particularly in resource-limited settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an individual randomized controlled trial (RCT) with a pretest-posttest design. Participants are randomly assigned in a 1:1 ratio using stratified block randomization into two parallel groups: an intervention group receiving the PCYCARE digital self-care program for 21 days, and a control group receiving routine antenatal care. The study evaluates the effectiveness of the intervention in improving maternal knowledge, childbirth preparedness, sleep quality, and reducing pregnancy-related anxiety.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: PCYCARE Digital Self-Care ProgramArm Type: Experimental Arm Name: PCYCARE Intervention Group Description: Participants in this group receive the PCYCARE digital self-care program for 21 days. The program consists of two components: 1. educational modules aimed at improving maternal knowledge and childbirth preparedness, and 2. guided audio relaxation sessions designed to support emotional regulation and improve sleep quality. Participants are instructed to complete two sessions per day (education and relaxation), each lasting approximately 10-15 minutes. |
| Routine Antenatal Care Group (control) | Active comparator | Other: Routine Antenatal CareArm Type: Active Comparator Arm Name: Routine Antenatal Care Group Description: Participants in this group receive routine antenatal care without access to the PCYCARE digital intervention. Standard care includes regular antenatal check-ups, health education, and routine maternal monitoring according to local clinical guidelines. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women aged 20-35 years
- Gestational age between 28 and 35 weeks (third trimester)
- Primigravida
- Able to read and understand the language used in the PCYCARE platform
- Owns a smartphone or digital device with internet access
Key exclusion criteria (3 listed)
- High-risk pregnancy requiring intensive medical care
- Severe psychiatric or cognitive disorders that may interfere with participation
- Participation in another intervention or educational program that may affect study outcomes
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 |
|---|---|---|
| PCYCARE Digital Self-Care ProgramAlso: Pregnancy Care App, Digital Pregnancy Self-Care InterventionPCYCARE is a mobile-based digital self-care intervention designed for third-trimester pregnant women. The program integrates two main components: (1) structured educational modules aimed at improving maternal knowledge and childbirth preparedness (cognitive and psychosocial domains), and (2) guided audio relaxation sessions designed to support emotional regulation and improve sleep quality (physiological domain). Participants are instructed to engage with the program twice daily for 21 days, completing both educational and relaxation sessions. Each session lasts approximately 10-15 minutes. The intervention is designed to support integrated biopsychosocial adaptation and reduce pregnancy-related anxiety. | Behavioural | Intervention Group |
| Routine Antenatal CareParticipants receive routine antenatal care according to local clinical practice guidelines. Standard care includes regular antenatal check-ups, basic maternal health education, and routine monitoring of pregnancy. No additional digital self-care intervention or structured program is provided during the study period. | Other | Routine Antenatal Care Group (control) |
Primary outcome
Change in Pregnancy-Related Anxiety
Time frame: Baseline and 21 days (post-intervention)
Pregnancy-related anxiety is assessed using the Late Pregnancy Anxiety Scale-Indonesian Version (LPAS-ID), an 8-item Likert-type scale. Each item is rated on a 4-point scale, with higher total scores indicating greater levels of anxiety. The outcome is defined as the change in total score from baseline to post-intervention.
3 secondary outcomes
Change in Sleep Quality
Time frame: Baseline and 21 days (post-intervention)
Change in Maternal Knowledge
Time frame: Baseline and 21 days (post-intervention)
Change in Childbirth Preparedness
Time frame: Baseline and 21 days (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publicationJannah, N., & Selvarajh, G. (2026). Late-pregnancy anxiety as a distinct multidimensional construct: Psychometric evidence from a community-based sample. Science Midwifery, 13(6), 1562-1570
- Results publicationJannah, N., Selvarajh, G., & Lestari, S. (2025). Feasibility and Acceptability of PcyCare: A Self-Directed Digital Platform for Maternal Health Literacy and Emotional Support. International Journal of Nursing Information, 4(2), 12-22.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected during this study will not be shared with other researchers outside the study team. This decision is based on considerations of participant confidentiality, ethical approval limitations, and the scope of the current research. All data will be used solely for the purposes of this study and will remain under the control of the principal investigator and affiliated institution.
Related trials for Pregnancy-Related Anxiety (PrA)
Not yet recruiting
A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women
Pregnancy-Related Anxiety (PrA), Fear of Childbirth
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. This study is not recruiting at the moment.
Nurul Jannah, M.Tr.Keb principal investigator
Lincoln University College Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCYCARE Digital Self-Care Program and Routine Antenatal Care in people with Pregnancy-Related Anxiety (PrA) and Anxiety, run by Lincoln University College Malaysia at 1 site in Indonesia.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pregnancy-Related Anxiety (time frame: Baseline and 21 days (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229989, which also lists 2 linked publications.
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 7 Apr 2026.