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

NCT07058142 | Completed

• 1 other identifier: 2023-SOG-23
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Interaction standard theory-based multi-care; Postpartum hemorrhage; Postpartum recovery; Quality of life; Coping styles; Psychological distress; Nursing intervention

Outcome Measures

Primary Outcomes (8)

• Change in Coping Styles (Positive Coping)

  Assessed using the Simplified Coping Style Questionnaire (SCSQ) positive coping subscale (0-36 points). Higher scores indicate more positive coping.

  Baseline (1 day post-PPH event) and 2 weeks post-intervention.

• Change in Coping Styles (Negative Coping)

  Assessed using the Simplified Coping Style Questionnaire (SCSQ) negative coping subscale (0-24 points). Lower scores indicate less negative coping.

  Baseline (1 day post-PPH event) and 2 weeks post-intervention.

• Change in Depression Severity

  Assessed using the Hamilton Depression Rating Scale (HAMD-17). Total score ranges, with scores \>24 indicating severe depression, 18-24 moderate, 7-17 mild. Lower scores indicate less depression.

  Baseline (1 day post-PPH event) and 2 weeks post-intervention (or 1 day before discharge if earlier).

• Change in Anxiety Severity

  Assessed using the Hamilton Anxiety Rating Scale (HAMA). Total score up to 56, with scores ≥29 severe anxiety, ≥21 definite, ≥14 mild, ≥7 possible. Lower scores indicate less anxiety.

  Baseline (1 day post-PPH event) and 2 weeks post-intervention (or 1 day before discharge if earlier).

• Change in Quality of Life

  Assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF). Consists of 26 items across four dimensions (Environment, Physical, Psychological, Social Relations). Each item scored 0-5, higher total scores indicate better quality of life.

  Baseline (1 day post-PPH event) and 2 weeks post-intervention.

• Duration of Lochia

  Time in days from delivery until lochia cessation.

  Assessed up to 2 weeks post-intervention.

• Time for Uterus to Return to Pelvic Cavity (Uterine Involution)

  Time in days from delivery for the uterus to involute to the pelvic cavity.

  Assessed up to 2 weeks post-intervention.

• Length of Hospitalization

  Duration of hospital stay in days post-PPH event.

  From enrollment until hospital discharge (up to approximately 1 week)

Secondary Outcomes (1)

• Nursing Satisfaction Rate

  At discharge (within 2 weeks post-intervention).

Study Arms (2)

Interaction Standard Theory-Based Multi-Care Program Group

EXPERIMENTAL

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

Behavioral: Interaction Standard Theory-Based Multi-Care Program

Conventional Nursing Intervention Group

ACTIVE COMPARATOR

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.

Behavioral: Conventional Nursing Intervention

Interventions

Interaction Standard Theory-Based Multi-Care Program 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.

Interaction Standard Theory-Based Multi-Care Program Group

Conventional Nursing Intervention BEHAVIORAL

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

Conventional Nursing Intervention Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xingxing Lv: lead

Study Sites (1)

Shijiazhuang Obstetrics and Gynecology Hospital

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Na Li

  Shijiazhuang Obstetrics and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 10, 2025
• Study Start: October 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-06

Locations

CN (1)