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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Coping Styles (Positive Coping)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Coping Styles (Positive Coping)
时间窗: 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)
时间窗: 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 Anxiety Severity
时间窗: 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.
Length of Hospitalization
时间窗: From enrollment until hospital discharge (up to approximately 1 week)
Duration of hospital stay in days post-PPH event.
Change in Depression Severity
时间窗: 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.
Change in Quality of Life
时间窗: 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.
Duration of Lochia
时间窗: Assessed up to 2 weeks post-intervention.
Time in days from delivery until lochia cessation.
Time for Uterus to Return to Pelvic Cavity (Uterine Involution)
时间窗: Assessed up to 2 weeks post-intervention.
Time in days from delivery for the uterus to involute to the pelvic cavity.
次要结局
- Nursing Satisfaction Rate(At discharge (within 2 weeks post-intervention).)
研究者
Xingxing Lv
Principal Investigator
Shijiazhuang Obstetrics and Gynecology Hospital