Postpartum HemorrhageNCT07058142
Effects of an Interaction-Based Multi-Care Program on Postpartum Hemorrhage Recovery
A study testing Interaction Standard Theory-Based Multi-Care Program and Conventional Nursing Intervention in people with Postpartum Hemorrhage and Postpartum Period, run by Xingxing Lv at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Postpartum Hemorrhage, Postpartum Period, Psychological Distress
- What is being tested?
- Interaction Standard Theory-Based Multi-Care Program and Conventional Nursing Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Shijiazhuang Obstetrics and Gynecology Hospital
Shijiazhuang, Hebei, 050000
About this study
Official 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
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.
Read the 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.
- Being tested
- Interaction Standard Theory-Based Multi-Care Program, Conventional Nursing Intervention
- Keywords
- Interaction standard theory-based multi-care, Postpartum hemorrhage, Postpartum recovery, Quality of life, Coping styles, Psychological distress, Nursing intervention
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction Standard Theory-Based Multi-Care ProgramBehavioural
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 InterventionBehavioural
Standard hospital protocol for postpartum hemorrhage management including physiological monitoring, emergency measures as needed, and basic postpartum care education.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Conventional Nursing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (1 day post-PPH event) and 2 weeks post-intervention.
Duration of Lochia
Time in days from delivery until lochia cessation.
Measured: 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.
Measured: Assessed up to 2 weeks post-intervention.
Length of Hospitalization
Duration of hospital stay in days post-PPH event.
Measured: From enrollment until hospital discharge (up to approximately 1 week)
Secondary outcomes (1)
Nursing Satisfaction Rate
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%.
Measured: At discharge (within 2 weeks post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Oct 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xingxing Lv
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingxing Lv, Shijiazhuang Obstetrics and Gynecology Hospital
- Investigators
- Na Li, Principal investigator, Shijiazhuang Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058142
- Sponsor's protocol ID
- 2023-SOG-23
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07058142
- Acronym / sponsor ID
- 2023-SOG-23
- Keywords
- Interaction standard theory-based multi-care, Postpartum hemorrhage, Postpartum recovery, Quality of life, Coping styles, Psychological distress, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Xingxing LvUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interaction Standard Theory-Based Multi-Care Program Group | Experimental | Behavioral: Interaction Standard Theory-Based Multi-Care ProgramParticipants 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 |
| Conventional Nursing Intervention Group | Active comparator | Behavioral: Conventional Nursing InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interaction Standard Theory-Based Multi-Care ProgramA 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. | Behavioural | Interaction Standard Theory-Based Multi-Care Program Group |
| Conventional Nursing InterventionStandard hospital protocol for postpartum hemorrhage management including physiological monitoring, emergency measures as needed, and basic postpartum care education. | Behavioural | Conventional Nursing Intervention Group |
Primary outcome
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.
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.
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.
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.
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.
Duration of Lochia
Time frame: 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)
Time frame: Assessed up to 2 weeks post-intervention.
Time in days from delivery for the uterus to involute to the pelvic cavity.
Length of Hospitalization
Time frame: From enrollment until hospital discharge (up to approximately 1 week)
Duration of hospital stay in days post-PPH event.
1 secondary outcome
Nursing Satisfaction Rate
Time frame: At discharge (within 2 weeks post-intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Na Li principal investigator
Shijiazhuang Obstetrics and Gynecology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction Standard Theory-Based Multi-Care Program and Conventional Nursing Intervention in people with Postpartum Hemorrhage and Postpartum Period, run by Xingxing Lv at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Coping Styles (Positive Coping) (time frame: Baseline (1 day post-PPH event) and 2 weeks post-intervention.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.