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Completed

NCT Number: NCT07058142

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

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shijiazhuang Obstetrics and Gynecology Hospital

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Conventional Nursing Intervention

Behavioral

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

Primary outcomes

  1. Change in Coping Styles (Positive Coping)

    Time frame: 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.

  2. Change in Coping Styles (Negative Coping)

    Time frame: 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.

  3. Change in Depression Severity

    Time frame: Baseline (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.

  4. Change in Anxiety Severity

    Time frame: Baseline (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.

  5. Change in Quality of Life

    Time frame: Baseline (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.

  6. Duration of Lochia

    Time frame: Assessed up to 2 weeks post-intervention.

    Time in days from delivery until lochia cessation.

  7. Time for Uterus to Return to Pelvic Cavity (Uterine Involution)

    Time frame: Assessed up to 2 weeks post-intervention.

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

  8. Length of Hospitalization

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

    Duration of hospital stay in days post-PPH event.

Secondary outcomes

  1. Nursing Satisfaction Rate

    Time frame: At 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%.

Sponsors and collaborators

Lead sponsor

Xingxing Lv

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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