Fear of ChildbirthNCT07321457
Effects of Watson's Human Caring Theory-Based Nursing Care on Fear of Childbirth and Birth Experience
A study testing Intervention Group: Watson's Human Caring Theory-Based Nursing Care and Routine Nursing Care in people with Fear of Childbirth and Childbirth Experience, run by Near East University, Turkey at 1 site in Cyprus.
Trial summary
The purpose of this clinical trial was to evaluate the effect of integrating a nursing care program based on Watson's Theory of Human Caring into the childbirth process on mothers' fear of childbirth and childbirth experience among women who had uncomplicated vaginal births. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Childbirth Experience
- What is being tested?
- Intervention Group: Watson's Human Caring Theory-Based Nursing Care and Routine Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCyprus
- Study dates
- 8 Jul 2024to 15 Mar 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women ≥18 years, at 37-41 weeks of gestation, Pregnant women in the active phase of labor (cervical dilation ≥ 3 cm). Pregnant women who presented with spontaneous labor were directed to vaginal de-livery after physician evaluation.
- Pregnant women carrying a single fetus in a vertex presentation. Pregnant women with an estimated fetal weight between 2500 4000 grams. Pregnant women undergo regular uterine contractions characteristic of the active phase.
- Pregnant women who are literate in Turkish.
Who cannot join
- Pregnant women younger than 18 years. Pregnant women older than 45 years. Pregnant women with multiple pregnancies. Pregnant women with a history of in vitro fertilization (IVF). Pregnant women in the latent phase with cervical dilation < 3 cm. Pregnant women who received spinal, epidural, or general anesthesia during la-bor.
- Pregnant women with a previous cesarean section (C/S). Pregnant women with a history of uterine surgery. Pregnant women whose delivery resulted in an emergency cesarean section. Pregnant women diagnosed with a mental disorder. Pregnant women showing signs of tokophobia (clinical fear of childbirth. Pregnant women who were separated from their newborn baby for medical reasons after delivery.
- Pregnant women with a history of preeclampsia. Pregnant women with premature rupture of membranes (PROM). Pregnant women with placenta anomalies (placenta previa, placental abruptio, etc.).
- Pregnant women with chronic diseases (DM, HT, etc.). Pregnant women with infectious diseases or active infections. Pregnant women with anemia. Pregnant women with fetal macrosomia. Pregnant women with vaginal bleeding. Pregnant women with abnormal vital signs. Pregnant women with presentation anomalies (breech, transverse)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Watson's Human Caring Theory-Based Nursing Care on Fear of Childbirth and Birth Experience: A Randomized Controlled Trial
The purpose of this clinical trial was to evaluate the effect of integrating a nursing care program based on Watson's Theory of Human Caring into the childbirth process on mothers' fear of childbirth and childbirth experience among women who had uncomplicated vaginal births.
The study aimed to examine whether nursing care structured according to Watson's Theory of Human Caring differed from routine nursing care in terms of fear of childbirth and childbirth experience during labor.
Read more
Researchers compared an intervention group, which received Watson's Theory-based nursing care, with a control group, which received routine nursing care, using standardized assessment tools.
Participants:
Received either nursing care based on Watson's Theory of Human Caring or routine nursing care during labor
Completed the Fear of Childbirth Scale (FOBS) and the Questionnaire for Assessing Childbirth Experience (QACE)
Were monitored and assessed throughout the labor process
Read the detailed description
This randomized controlled trial was designed to evaluate the effect of integrating a nursing care program based on Watson's Theory of Human Caring into the childbirth process on mothers' fear of childbirth and childbirth experience.
The study was conducted at a public hospital in Northern Cyprus between May 2024 and March 2025. A total of 30 mothers who experienced uncomplicated vaginal births were enrolled and randomly assigned to either the intervention group (n = 15) or the control group (n = 15).
The control group received routine nursing care, while the intervention group received nursing care structured according to Watson's Theory of Human Caring. The study employed a single-blind design, in which participants were unaware of their group allocation.
Data were collected using the Fear of Childbirth Scale (FOBS) and the Questionnaire for Assessing the Childbirth Experience - Short Version (QACE). These instruments were used to assess fear of childbirth and childbirth experience during labor and the postpartum period.
Statistical analyses were planned to compare outcomes between the intervention and control groups and to examine the effect of theory-based nursing care on fear of childbirth and childbirth experience.
- Conditions
- Fear of Childbirth, Childbirth Experience
- Being tested
- Intervention Group: Watson's Human Caring Theory-Based Nursing Care, Routine Nursing Care
- Keywords
- childbirth, caring, fear, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group: Watson's Human Caring Theory-Based Nursing CareBehavioural
Mothers in the intervention group received nursing care based on Watson's Human Caring Theory during labor. This care included individualized emotional support, therapeutic communication, and other nursing interventions designed to reduce fear of childbirth and enhance overall birth experience. The program was specifically tailored to each mother's needs, distinguishing it from routine nursing care provided in standard labor management.
Routine Nursing CareBehavioural
Mothers in the control group received routine nursing care during labor. No additional interventions based on Watson's Human Caring Theory were administered. This care followed standard hospital procedures for labor and delivery, without any individualized behavioral or supportive programs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Mothers in the intervention group received nursing care based on Watson's Human Caring Theory during labor. This care included emotional support, therapeutic communication, and individualized interventions aimed at reducing fear of childbirth and improving overall birth experience. Receives: Behavioral: Intervention Group: Watson's Human Caring Theory-Based Nursing Care |
| Control Group | Active comparator | Mothers in the control group received routine nursing care during labor. No additional interventions based on Watson's Human Caring Theory were administered. Receives: Behavioral: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Experience
Mothers' overall childbirth experience was assessed using the validated Questionnaire for Assessing Childbirth Experience - Short Version (QACE) through telephone interviews conducted 1 to 1.5 months after delivery. Each dimension of the QACE is scored on a scale ranging from 1 to 4, with higher scores indicating more negative childbirth experiences.
Measured: 1-1.5 months postpartum
Fear of Childbirth Scale
The level of fear experienced by mothers during labor was assessed using the validated Fear of Childbirth Scale (FOBS). The total score of the FOBS ranges from 0 to 100, with higher scores indicating higher levels of fear of childbirth. A cut-off score of 50 was used to classify participants as having fear of childbirth.
Measured: During the active and transition phases of the first stage of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start8 Jul 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candan Ozturk, Near East University, Turkey
- Investigators
- Candan Ozturk, Prof. Dr., Principal investigator, Near East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321457
- Sponsor's protocol ID
- YTK.1.01
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared. The dataset contains sensitive personal health information collected from mothers during labor, and sharing is restricted to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Watson's Human Caring Theory-Based Nursing Care on Fear of Childbirth and Birth Experience: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07321457
- Acronym / sponsor ID
- YTK.1.01
- Conditions
- Fear of Childbirth, Childbirth Experience
- Keywords
- childbirth, caring, fear, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 7 Jan 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.
The purpose of this clinical trial was to evaluate the effect of integrating a nursing care program based on Watson's Theory of Human Caring into the childbirth process on mothers' fear of childbirth and childbirth experience among women who had uncomplicated vaginal births.
The study aimed to examine whether nursing care structured according to Watson's Theory of Human Caring differed from routine nursing care in terms of fear of childbirth and childbirth experience during labor.
Researchers compared an intervention group, which received Watson's Theory-based nursing care, with a control group, which received routine nursing care, using standardized assessment tools.
Participants:
Received either nursing care based on Watson's Theory of Human Caring or routine nursing care during labor
Completed the Fear of Childbirth Scale (FOBS) and the Questionnaire for Assessing Childbirth Experience (QACE)
Were monitored and assessed throughout the labor process
Detailed description
This randomized controlled trial was designed to evaluate the effect of integrating a nursing care program based on Watson's Theory of Human Caring into the childbirth process on mothers' fear of childbirth and childbirth experience.
The study was conducted at a public hospital in Northern Cyprus between May 2024 and March 2025. A total of 30 mothers who experienced uncomplicated vaginal births were enrolled and randomly assigned to either the intervention group (n = 15) or the control group (n = 15).
The control group received routine nursing care, while the intervention group received nursing care structured according to Watson's Theory of Human Caring. The study employed a single-blind design, in which participants were unaware of their group allocation.
Data were collected using the Fear of Childbirth Scale (FOBS) and the Questionnaire for Assessing the Childbirth Experience - Short Version (QACE). These instruments were used to assess fear of childbirth and childbirth experience during labor and the postpartum period.
Statistical analyses were planned to compare outcomes between the intervention and control groups and to examine the effect of theory-based nursing care on fear of childbirth and childbirth experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention Group: Watson's Human Caring Theory-Based Nursing CareMothers in the intervention group received nursing care based on Watson's Human Caring Theory during labor. This care included emotional support, therapeutic communication, and individualized interventions aimed at reducing fear of childbirth and improving overall birth experience. |
| Control Group | Active comparator | Behavioral: Routine Nursing CareMothers in the control group received routine nursing care during labor. No additional interventions based on Watson's Human Caring Theory were administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women ≥18 years, at 37-41 weeks of gestation, Pregnant women in the active phase of labor (cervical dilation ≥ 3 cm). Pregnant women who presented with spontaneous labor were directed to vaginal de-livery after physician evaluation.
- Pregnant women carrying a single fetus in a vertex presentation. Pregnant women with an estimated fetal weight between 2500 4000 grams. Pregnant women undergo regular uterine contractions characteristic of the active phase.
- Pregnant women who are literate in Turkish.
Key exclusion criteria (4 listed)
- Pregnant women younger than 18 years. Pregnant women older than 45 years. Pregnant women with multiple pregnancies. Pregnant women with a history of in vitro fertilization (IVF). Pregnant women in the latent phase with cervical dilation < 3 cm. Pregnant women who received spinal, epidural, or general anesthesia during la-bor.
- Pregnant women with a previous cesarean section (C/S). Pregnant women with a history of uterine surgery. Pregnant women whose delivery resulted in an emergency cesarean section. Pregnant women diagnosed with a mental disorder. Pregnant women showing signs of tokophobia (clinical fear of childbirth. Pregnant women who were separated from their newborn baby for medical reasons after delivery.
- Pregnant women with a history of preeclampsia. Pregnant women with premature rupture of membranes (PROM). Pregnant women with placenta anomalies (placenta previa, placental abruptio, etc.).
- Pregnant women with chronic diseases (DM, HT, etc.). Pregnant women with infectious diseases or active infections. Pregnant women with anemia. Pregnant women with fetal macrosomia. Pregnant women with vaginal bleeding. Pregnant women with abnormal vital signs. Pregnant women with presentation anomalies (breech, transverse)
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 |
|---|---|---|
| Intervention Group: Watson's Human Caring Theory-Based Nursing CareMothers in the intervention group received nursing care based on Watson's Human Caring Theory during labor. This care included individualized emotional support, therapeutic communication, and other nursing interventions designed to reduce fear of childbirth and enhance overall birth experience. The program was specifically tailored to each mother's needs, distinguishing it from routine nursing care provided in standard labor management. | Behavioural | Intervention Group |
| Routine Nursing CareMothers in the control group received routine nursing care during labor. No additional interventions based on Watson's Human Caring Theory were administered. This care followed standard hospital procedures for labor and delivery, without any individualized behavioral or supportive programs. | Behavioural | Control Group |
Primary outcome
Birth Experience
Time frame: 1-1.5 months postpartum
Mothers' overall childbirth experience was assessed using the validated Questionnaire for Assessing Childbirth Experience - Short Version (QACE) through telephone interviews conducted 1 to 1.5 months after delivery. Each dimension of the QACE is scored on a scale ranging from 1 to 4, with higher scores indicating more negative childbirth experiences.
Fear of Childbirth Scale
Time frame: During the active and transition phases of the first stage of labor
The level of fear experienced by mothers during labor was assessed using the validated Fear of Childbirth Scale (FOBS). The total score of the FOBS ranges from 0 to 100, with higher scores indicating higher levels of fear of childbirth. A cut-off score of 50 was used to classify participants as having fear of childbirth.
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 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared. The dataset contains sensitive personal health information collected from mothers during labor, and sharing is restricted to protect participant privacy and confidentiality.
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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. This study is not recruiting at the moment.
Candan Ozturk, Prof. Dr. principal investigator
Near East University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group: Watson's Human Caring Theory-Based Nursing Care and Routine Nursing Care in people with Fear of Childbirth and Childbirth Experience, run by Near East University, Turkey at 1 site in Cyprus.
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 3 inclusion and 4 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 Jan 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 Cyprus. 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?
Birth Experience (time frame: 1-1.5 months postpartum). The study lists 2 primary outcomes in all. 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 7 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.