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

The Effects of an Interaction Standard Theory-Based Multi-Care Program on Postpartum Recovery, Coping Styles, Psychological Distress, and Quality of Life in Women With Postpartum Hemorrhage

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07058142
Enrollment
110
Registered
2025-07-10
Start date
2023-10-01
Completion date
2024-10-31
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALInteraction 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.

BEHAVIORALConventional Nursing Intervention

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

Sponsors

Xingxing Lv
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Length of HospitalizationFrom enrollment until hospital discharge (up to approximately 1 week)Duration of hospital stay in days post-PPH event.
Change in Coping Styles (Positive Coping)Baseline (1 day post-PPH event) and 2 weeks post-intervention.Assessed using the Simplified Coping Style Questionnaire (SCSQ) positive coping subscale (0-36 points). Higher scores indicate more positive coping.
Change in Coping Styles (Negative Coping)Baseline (1 day post-PPH event) and 2 weeks post-intervention.Assessed using the Simplified Coping Style Questionnaire (SCSQ) negative coping subscale (0-24 points). Lower scores indicate less negative coping.
Change in Depression SeverityBaseline (1 day post-PPH event) and 2 weeks post-intervention (or 1 day before discharge if earlier).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.
Change in Anxiety SeverityBaseline (1 day post-PPH event) and 2 weeks post-intervention (or 1 day before discharge if earlier).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.
Change in Quality of LifeBaseline (1 day post-PPH event) and 2 weeks post-intervention.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.
Duration of LochiaAssessed up to 2 weeks post-intervention.Time in days from delivery until lochia cessation.
Time for Uterus to Return to Pelvic Cavity (Uterine Involution)Assessed up to 2 weeks post-intervention.Time in days from delivery for the uterus to involute to the pelvic cavity.

Secondary

MeasureTime frameDescription
Nursing Satisfaction RateAt discharge (within 2 weeks post-intervention).Assessed using a locally adapted patient satisfaction questionnaire (15 items) focusing on nursing care. Levels: satisfied, neutral, dissatisfied. Rate calculated as (Number of satisfied + neutral patients) / Total number of patients × 100%.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026