NCT07004062

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
Last Updated

June 4, 2025

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

May 15, 2025

Last Update Submit

May 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline to 6 months post-intervention.

Secondary Outcomes (1)

  • Patient Satisfaction with Nursing Care

    End of intervention (Week 12).

Other Outcomes (1)

  • Adherence to Lifestyle Interventions

    Weekly during intervention (Weeks 1-12).

Study Arms (2)

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.

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

Other: Structured Risk Assessment-Based Targeted Nursing Intervention

Interventions

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

control groupobservation group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of gynecological endocrine disorder
  • Aged 18-45 years
  • Complete clinical data available
  • Willing and able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200443, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2025

First Posted

June 4, 2025

Study Start

December 15, 2023

Primary Completion

June 7, 2024

Study Completion

June 27, 2024

Last Updated

June 4, 2025

Record last verified: 2023-12

Locations