Gynecological Endocrine DisordersNCT07004062
Application Value of Targeted Nursing Based on Risk Assessment Strategies in the Treatment of Patients With Gynecological Endocrine Disorders
A study testing Structured Risk Assessment-Based Targeted Nursing Intervention in people with Gynecological Endocrine Disorders and Risk Assessment, run by Obstetrics and Gynecology Hospital of Fudan University-Huangpu Campus at 1 site in China.
Trial summary
Risk-based targeted nursing significantly enhances clinical outcomes, quality of life, and mental health in patients with gynecological endocrine disorders, supporting its broader clinical application. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gynecological Endocrine Disorders, Risk Assessment, Targeted Nursing Care
- What is being tested?
- Structured Risk Assessment-Based Targeted Nursing Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2023to 27 Jun 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of gynecological endocrine disorder
- Aged 18-45 years
- Complete clinical data available
- Willing and able to provide informed consent
Who cannot join
- Severe systemic or psychiatric illness
- Recent major surgery or hormonal/fertility treatment (within 3 months)
- Known hypersensitivity to study medications
- Currently pregnant or breastfeeding
- Participation in another clinical trial within 6 months
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200443
About this study
Risk-based targeted nursing significantly enhances clinical outcomes, quality of life, and mental health in patients with gynecological endocrine disorders, supporting its broader clinical application.
Read the detailed description
To evaluate the clinical value of targeted nursing care based on risk assessment in patients with gynecological endocrine disorders.
A prospective controlled study was conducted to analyze the clinical data of 84 patients with endocrine disorders and 89 healthy women, focusing on identifying risk factors associated with endocrine disorders and designing corresponding personalized nursing interventions. A total of 154 patients with gynecological endocrine disorders, treated between December 2023 and June 2024, were randomly assigned into a control group (n = 77) and an observation group (n = 77) using a random number table method. The control group received routine nursing care, while the observation group received targeted nursing interventions based on risk assessment strategies in addition to routine care. Nursing outcomes, patient satisfaction, quality of life scores, and psychological status-including Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores-were compared between the two groups.
- Conditions
- Gynecological Endocrine Disorders, Risk Assessment, Targeted Nursing Care, Psychological Support, Quality of Life
- Being tested
- Structured Risk Assessment-Based Targeted Nursing Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Risk Assessment-Based Targeted Nursing InterventionOther
Comprehensive Risk Assessment: Evaluation of lifestyle factors (diet, exercise, sleep), psychosocial stressors, medical history, and endocrine-specific biomarkers
Personalized Care Plan: Tailored interventions addressing identified risk factors
Psychological Component: Cognitive-behavioral techniques and stress management
Lifestyle Modification: Guided nutrition (low-glycemic, high-fiber diet) and physical activity plans
Reproductive Health Support: Menstrual cycle monitoring and fertility-related counseling
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | In the control group, patients received routine nursing care, which primarily involved regular monitoring of vital signs such as blood pressure, temperature, pulse, and respiration. Basic health education was provided, focusing on lifestyle guidance including dietary control and daily routine recommendations. General psychological support was offered through emotional soothing and communicative care to alleviate anxiety. Medication management was strictly implemented in accordance with medical orders to ensure accurate drug administration. In addition, basic daily nursing operations were performed, including assistance with personal hygiene, regular turning to prevent pressure sores, and therapeutic massage when necessary. Receives: Other: Structured Risk Assessment-Based Targeted Nursing Intervention |
| observation group | Experimental | Patients in the observation group, on the other hand, received targeted nursing interventions based on a structured risk assessment strategy in addition to routine care. This included a comprehensive individualized health assessment that evaluated the patient's lifestyle, dietary habits, stress levels, sleep quality, medical history, and level of social support, leading to the formulation of a personalized nursing plan. Emotional and psychological support was intensified for patients experiencing emotional instability, employing interventions such as cognitive-behavioral therapy, relaxation training, and stress management techniques. Lifestyle interventions were also enhanced by guiding patients to establish regular routines, adopt low-sugar and high-fiber diets rich in vitamins, and engage in appropriate physical activity. Professional nursing interventions were applied to patients with menstrual irregularities or fertility-related needs, including ovulation monitoring and reproducti Receives: Other: Structured Risk Assessment-Based Targeted Nursing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy of Targeted Nursing in Gynecological Endocrine Disorders
Proportion of patients achieving significant improvement in endocrine symptoms (e.g., menstrual regularity, hormonal balance) post-intervention, assessed via physician evaluation and laboratory markers (e.g., LH/FSH ratio, testosterone levels).
Measured: Baseline to 6 months post-intervention.
Secondary outcomes (1)
Patient Satisfaction with Nursing Care
Satisfaction rates measured via a 5-point Likert scale survey (1 = "very dissatisfied" to 5 = "very satisfied"), including domains of communication, pain management, and emotional support.
Measured: End of intervention (Week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start15 Dec 2023
- Primary completion7 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological Endocrine DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrics and Gynecology Hospital of Fudan University-Huangpu Campus
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Haiyan Wang, Obstetrics and Gynecology Hospital of Fudan University-Huangpu Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004062
- Sponsor's protocol ID
- No.20230815
- Status last verified
- Dec 2023
- First submitted
- 15 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Value of Targeted Nursing Based on Risk Assessment Strategies in the Treatment of Patients With Gynecological Endocrine Disorders
- ClinicalTrials.gov ID
- NCT07004062
- Acronym / sponsor ID
- No.20230815
- Conditions
- Gynecological Endocrine Disorders, Risk Assessment, Targeted Nursing Care, Psychological Support, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Obstetrics and Gynecology Hospital of Fudan University-Huangpu CampusOther government
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 4 Jun 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.
Risk-based targeted nursing significantly enhances clinical outcomes, quality of life, and mental health in patients with gynecological endocrine disorders, supporting its broader clinical application.
Detailed description
To evaluate the clinical value of targeted nursing care based on risk assessment in patients with gynecological endocrine disorders.
A prospective controlled study was conducted to analyze the clinical data of 84 patients with endocrine disorders and 89 healthy women, focusing on identifying risk factors associated with endocrine disorders and designing corresponding personalized nursing interventions. A total of 154 patients with gynecological endocrine disorders, treated between December 2023 and June 2024, were randomly assigned into a control group (n = 77) and an observation group (n = 77) using a random number table method. The control group received routine nursing care, while the observation group received targeted nursing interventions based on risk assessment strategies in addition to routine care. Nursing outcomes, patient satisfaction, quality of life scores, and psychological status-including Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores-were compared between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: Structured Risk Assessment-Based Targeted Nursing InterventionIn the control group, patients received routine nursing care, which primarily involved regular monitoring of vital signs such as blood pressure, temperature, pulse, and respiration. Basic health education was provided, focusing on lifestyle guidance including dietary control and daily routine recommendations. General psychological support was offered through emotional soothing and communicative care to alleviate anxiety. Medication management was strictly implemented in accordance with medical orders to ensure accurate drug administration. In addition, basic daily nursing operations were performed, including assistance with personal hygiene, regular turning to prevent pressure sores, and therapeutic massage when necessary. |
| observation group | Experimental | Other: Structured Risk Assessment-Based Targeted Nursing InterventionPatients in the observation group, on the other hand, received targeted nursing interventions based on a structured risk assessment strategy in addition to routine care. This included a comprehensive individualized health assessment that evaluated the patient's lifestyle, dietary habits, stress levels, sleep quality, medical history, and level of social support, leading to the formulation of a personalized nursing plan. Emotional and psychological support was intensified for patients experiencing emotional instability, employing interventions such as cognitive-behavioral therapy, relaxation training, and stress management techniques. Lifestyle interventions were also enhanced by guiding patients to establish regular routines, adopt low-sugar and high-fiber diets rich in vitamins, and engage in appropriate physical activity. Professional nursing interventions were applied to patients with menstrual irregularities or fertility-related needs, including ovulation monitoring and reproducti |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of gynecological endocrine disorder
- Aged 18-45 years
- Complete clinical data available
- Willing and able to provide informed consent
Key exclusion criteria (5 listed)
- Severe systemic or psychiatric illness
- Recent major surgery or hormonal/fertility treatment (within 3 months)
- Known hypersensitivity to study medications
- Currently pregnant or breastfeeding
- Participation in another clinical trial within 6 months
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 |
|---|---|---|
| Structured Risk Assessment-Based Targeted Nursing InterventionComprehensive Risk Assessment: Evaluation of lifestyle factors (diet, exercise, sleep), psychosocial stressors, medical history, and endocrine-specific biomarkers Personalized Care Plan: Tailored interventions addressing identified risk factors Psychological Component: Cognitive-behavioral techniques and stress management Lifestyle Modification: Guided nutrition (low-glycemic, high-fiber diet) and physical activity plans Reproductive Health Support: Menstrual cycle monitoring and fertility-related counseling | Other | control group, observation group |
Primary outcome
Clinical Efficacy of Targeted Nursing in Gynecological Endocrine Disorders
Time frame: Baseline to 6 months post-intervention.
Proportion of patients achieving significant improvement in endocrine symptoms (e.g., menstrual regularity, hormonal balance) post-intervention, assessed via physician evaluation and laboratory markers (e.g., LH/FSH ratio, testosterone levels).
1 secondary outcome
Patient Satisfaction with Nursing Care
Time frame: End of intervention (Week 12).
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 4 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Risk Assessment-Based Targeted Nursing Intervention in people with Gynecological Endocrine Disorders and Risk Assessment, run by Obstetrics and Gynecology Hospital of Fudan University-Huangpu Campus at 1 site in China.
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 4 inclusion and 5 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 4 Jun 2025. 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 China. 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?
Clinical Efficacy of Targeted Nursing in Gynecological Endocrine Disorders (time frame: Baseline to 6 months post-intervention.). 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 4 Jun 2025.