Effects of an Interaction-Based Multi-Care Program on Postpartum Hemorrhage Recovery

NCT ID: NCT07058142

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-10-31

Brief Summary

This study explored the impact of an interaction standard theory-based multi-care program on postpartum recovery, coping styles, psychological distress, and quality of life in women experiencing postpartum hemorrhage (PPH). A total of 110 women with PPH were randomized into a study group receiving the multi-care program or a control group receiving conventional nursing. Outcomes were assessed at baseline and 2 weeks post-intervention. The multi-care program significantly improved postpartum recovery, enhanced adaptive coping, reduced psychological distress, and improved quality of life compared to conventional care.

Detailed Description

Postpartum hemorrhage (PPH) is a severe obstetric complication. While standard medical care addresses the physiological crisis, the psychosocial needs and coping mechanisms of women experiencing PPH may be inadequately addressed by conventional nursing. This prospective, randomized controlled trial aimed to evaluate an interaction standard theory-based multi-care program, integrating King's Theory of Goal Attainment and Satir's model, for women with PPH. Participants (n=110) admitted to Shijiazhuang Obstetrics and Gynecology Hospital from October 2023 to October 2024 were randomly assigned to the study group (n=55) receiving the multi-care program or the control group (n=55) receiving conventional nursing. The multi-care program included collective training for nursing staff, individualized patient data collection, collaborative care plan development, and specific interventions in hemorrhage care, psychological care (empathetic listening, Satir's communication stances, music therapy, guided imagery), cognitive intervention (education on PPH), dietary care, and rehabilitation training. Follow-up occurred at 1 and 2 weeks post-discharge. The study assessed changes in coping styles (SCSQ), psychological distress (HAMD, HAMA), quality of life (WHOQOL-BREF), postpartum recovery indicators (lochia duration, lactation onset, uterine involution, hospital stay), and nursing satisfaction. The study was designed and reported following CONSORT guidelines.

Conditions

Postpartum Hemorrhage; Postpartum Period; Psychological Distress; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interaction Standard Theory-Based Multi-Care Program Group

Participants received conventional nursing care plus an interaction standard theory-based multi-care program. This program involved:

• Collective training for nursing staff on interaction theories and PPH care.
• One-on-one communication to assess patient's psychological state, background, and needs.
• Collaborative development of a multi-dimensional care plan.
• Specific interventions including:
• Hemorrhage Care: Encouraging early breastfeeding, monitoring bleeding, administering uterotonics if needed, abdominal massage.
• Psychological Care: Empathetic listening, Satir's communication stances, music therapy, deep breathing, guided imagery.
• Cognitive Intervention: Education on PPH causes, treatments, complications using various materials.
• Dietary Care: Scientific, balanced dietary plan emphasizing high-calorie, high-protein foods.
• Rehabilitation Training: Ensuring warmth, sleep, abdominal massage, gentle vaginal pressure, early ambulation, specific exercises.
• Implementation

Group Type: EXPERIMENTAL

Interaction Standard Theory-Based Multi-Care Program

Intervention Type: BEHAVIORAL

A comprehensive nursing program based on King's Theory of Goal Attainment and Satir's model, focusing on structured nurse-patient communication, shared goal-setting, and multi-dimensional care addressing cognitive, psychological, behavioral, and dietary aspects. Delivered daily during hospitalization (30-45 min sessions) with post-discharge follow-up.

Conventional Nursing Intervention Group

Participants received standard conventional nursing interventions as per the hospital's established protocol for postpartum hemorrhage management. This included careful examination of the soft birth canal and placenta, monitoring vital signs, administering oxygen therapy or blood transfusion if indicated, maintaining communication with the patient's family, and providing basic oral education regarding routine postpartum self-care.

Group Type: ACTIVE_COMPARATOR

Conventional Nursing Intervention

Intervention Type: BEHAVIORAL

Standard hospital protocol for postpartum hemorrhage management including physiological monitoring, emergency measures as needed, and basic postpartum care education.

Interventions

Interaction Standard Theory-Based Multi-Care Program

A comprehensive nursing program based on King's Theory of Goal Attainment and Satir's model, focusing on structured nurse-patient communication, shared goal-setting, and multi-dimensional care addressing cognitive, psychological, behavioral, and dietary aspects. Delivered daily during hospitalization (30-45 min sessions) with post-discharge follow-up.

Intervention Type: BEHAVIORAL

Conventional Nursing Intervention

Standard hospital protocol for postpartum hemorrhage management including physiological monitoring, emergency measures as needed, and basic postpartum care education.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Delivered in our hospital and received postpartum treatment, with a blood loss >500 mL within 24 hours after delivery;
• Age <40 years;
• Single live birth at full term;
• Stable vital signs;
• No pregnancy-related complications (other than PPH itself post-diagnosis);
• Clear cognitive function and self-awareness;
• Normal hearing and communication ability.

Exclusion Criteria

• Cervical laceration (as primary cause of PPH if not manageable by standard protocol and requiring extensive surgical repair beyond typical scope);
• Pre-existing severe cardiovascular diseases;
• Pre-existing severe renal, cardiac, or hepatic insufficiency;
• Known pre-existing coagulation disorders;
• Active systemic infectious diseases;
• Malignant tumors;
• Cellular immune function defects;
• Incomplete data or withdrawal from the study (prior to completion of the 2-week follow-up, though none occurred).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xingxing Lv

OTHER

Sponsor Role: lead

Responsible Party

Xingxing Lv

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Na Li

Role: PRINCIPAL_INVESTIGATOR

Shijiazhuang Obstetrics and Gynecology Hospital

Locations

Shijiazhuang Obstetrics and Gynecology Hospital

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2023-SOG-23

Identifier Type: -

Identifier Source: org_study_id