High-Risk Pregnancy, Premature Rupture of Membranes (PROM), Preterm Premature Rupture of Membranes (PPROM)
Conditions
Keywords
Emotional Freedom Technique, Music Therapy, High-Risk Pregnancy, PPROM, Maternal Mental Health, Anxiety, Depression, Stress, Coping Strategies, Non-Stress Test, Fetal Well-Being
Brief summary
Pregnancy is a physiological process; however, it is also a dynamic period during which obstetric and medical complications that may threaten maternal and fetal health can occur. In the presence of such complications, pregnancy is defined as a high-risk pregnancy, accounting for approximately 10-20% of all pregnancies. Due to the increased risk of maternal and fetal morbidity and mortality, high-risk pregnancies are considered a significant public health issue. Among high-risk pregnancies, premature rupture of membranes (PROM) and particularly preterm premature rupture of membranes (PPROM) are obstetric conditions associated with serious risks for maternal and perinatal outcomes. PPROM is responsible for a substantial proportion of preterm births and is associated with an increased risk of neonatal complications. During the course of PROM and PPROM, the latency period between membrane rupture and delivery constitutes a significant source of uncertainty and psychosocial burden for pregnant women. Factors such as prolonged hospitalization, risk of complications, and fear of fetal loss may lead to increased levels of stress, anxiety, and depression in this population. In the face of intense stress and uncertainty, coping strategies emerge as an important determinant of psychological outcomes. Coping refers to the cognitive and behavioral efforts individuals employ to manage situations perceived as threatening and is generally classified into active and avoidant coping strategies. Avoidant coping strategies have been associated with higher levels of anxiety and depression, whereas adaptive coping strategies are reported to enhance psychological resilience. Maternal psychological status may influence not only the mother's mental health but also fetal well-being. In this context, the non-stress test (NST) is an important tool for evaluating fetal autonomic nervous system function and allows monitoring of the relationship between maternal psychological status and fetal physiological responses. However, findings regarding the relationship between maternal anxiety and depression and NST parameters remain inconsistent. Current clinical management of PROM and PPROM primarily focuses on preventing obstetric complications, while the maternal psychological dimension often remains secondary. Therefore, safe and feasible non-pharmacological interventions during pregnancy have gained increasing attention. Emotional Freedom Technique (EFT) and music therapy are among the non-pharmacological interventions shown to be effective in reducing stress, anxiety, and depression during pregnancy. However, no studies have been identified in the literature evaluating the effects of these interventions on maternal psychological status, coping strategies, and fetal well-being in high-risk pregnancy groups such as PROM and PPROM. Therefore, randomized controlled trials are needed to evaluate the effects of EFT and music therapy on maternal psychological status, coping strategies, and fetal well-being in pregnant women diagnosed with PPROM.
Detailed description
High-risk pregnancy is a dynamic condition characterized by medical or obstetric complications that may adversely affect maternal and fetal health. Among these, premature rupture of membranes (PROM) and particularly preterm premature rupture of membranes (PPROM) are associated with increased risks of maternal and perinatal morbidity and mortality. The latency period between membrane rupture and delivery often involves prolonged hospitalization, uncertainty, and concerns about pregnancy outcomes, which may lead to elevated levels of stress, anxiety, and depression in pregnant women . In this context, coping strategies play a critical role in determining psychological adaptation. Ineffective or avoidant coping strategies may exacerbate psychological distress, whereas adaptive coping strategies can enhance resilience and improve overall well-being. Moreover, maternal psychological status may influence fetal well-being through physiological mechanisms. Increased stress-related hormonal responses, such as elevated cortisol and catecholamine levels, may affect uteroplacental circulation and fetal autonomic nervous system regulation. The non-stress test (NST) is a widely used, non-invasive method for evaluating fetal well-being by assessing fetal heart rate patterns, variability, and accelerations. It provides an opportunity to examine the potential relationship between maternal psychological status and fetal physiological responses. However, current evidence regarding the association between maternal psychological factors and NST findings remains limited and inconsistent. Despite the clinical importance of psychological factors, the management of PROM and PPROM primarily focuses on preventing obstetric complications, while the psychosocial dimension often remains under-addressed. Therefore, there is an increasing need for safe, feasible, and non-pharmacological interventions that can support maternal psychological well-being and potentially improve fetal outcomes. Emotional Freedom Technique (EFT) and music therapy are non-invasive, low-cost interventions that have been shown to reduce stress, anxiety, and depression in various populations, including pregnant women. EFT is a mind-body intervention combining elements of cognitive-behavioral therapy and somatic stimulation of acupressure points, whereas music therapy promotes relaxation and emotional regulation through structured auditory stimulation. Both interventions are considered safe, easy to apply, and suitable for use in clinical settings. However, there is a lack of randomized controlled trials evaluating the effects of these interventions specifically in women diagnosed with PROM/PPROM, particularly in relation to maternal psychological status, coping strategies, and fetal well-being assessed through NST. This randomized controlled trial aims to evaluate the effects of Emotional Freedom Technique and music therapy on maternal psychological status, coping strategies, and non-stress test findings in high-risk pregnant women diagnosed with PPROM. Participants will be randomly assigned to an EFT group, a music therapy group, or a control group receiving routine care. The study is expected to provide evidence on the effectiveness of these non-pharmacological interventions and contribute to the integration of holistic, woman-centered approaches into the management of high-risk pregnancies.
Interventions
BEHAVIORALEmotional Freedom Technique (EFT)
Before the intervention, participants will receive standardized training on the EFT procedure using written and visual materials. The intervention is planned in two sessions. Following the pre-test assessments, the first 30-minute EFT session will be conducted by the researcher. After the first session, participants will be instructed to continue practicing EFT on their own every evening (preferably before bedtime) for seven days, and this process will be monitored daily by the researcher. At the end of one week, the second 30-minute EFT session will be administered by the researcher.
BEHAVIORALMusic Therapy
Before the intervention, participants will receive standardized training on the music therapy procedure using written and visual materials. The intervention is planned in two sessions. Following the pre-test assessments, the first 30-minute music therapy session will be conducted by the researcher. After the first session, participants will be instructed to listen to the same music track every evening (preferably before bedtime) for seven days, and this process will be monitored daily by the researcher. At the end of one week, the second 30-minute music therapy session will be administered by the researcher.
Sponsors
Selcuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The non-stress test (NST) findings will be evaluated by an obstetrician who is blinded to group allocation. In addition, statistical analyses will be conducted by a statistician who is blinded to group assignment.
Intervention model description
Participants will be randomly assigned to one of three parallel groups: Emotional Freedom Technique (EFT), music therapy, or a control group receiving routine care. Each participant will receive only one type of intervention, and outcomes will be assessed and compared between groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women aged 18 years and older * Able to speak and understand Turkish * Diagnosed with preterm premature rupture of membranes (PPROM) * Gestational age between 28+0 and 35+5 weeks * Score of ≥1 on the Subjective Units of Disturbance Scale (SUDS) * Singleton pregnancy * Able and willing to communicate and participate in the study
Exclusion criteria
* Pregnancy achieved via assisted reproductive technologies * Presence of any obstetric complication other than PPROM * Presence of major fetal anomalies * Active labor at the time of recruitment * Hearing impairment * Presence of infection, wounds, or scars at tapping sites (for EFT application) * History of severe psychiatric disorder or currently receiving psychiatric treatment * Any maternal or fetal condition requiring emergency medical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety Stress Scale-21 (DASS-21) | Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period | The Depression Anxiety Stress Scale - 21 Items (DASS-21) is a 21-item self-report scale. The total score ranges from 0 to 63, with higher scores indicating greater psychological distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coping Responses Inventory (CRI) | Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period | Coping methods measured by the Coping Responses Inventory (CRI). The Coping Responses Inventory (CRI) is a self-report scale consisting of 22 items assessing approach-oriented coping responses. Items are rated on a 5-point Likert scale ranging from 1 ("Never") to 5 ("Always"). The total score ranges from 22 to 110, with higher scores indicating more frequent and more effective use of coping strategies. |
| Subjective Units of Experience-SUE | Baseline, immediately after the first intervention session, 1 week after baseline (before the second session), and immediately after completion of the second (final) intervention session | Perceived emotional intensity measured by the Subjective Units of Experience (SUE) The Subjective Units of Experience (SUE) is a self-report scale used to assess perceived emotional intensity. Scores range from -10 to +10, where negative values indicate unpleasant emotional experiences, 0 indicates no emotion, and positive values indicate pleasant emotional experiences. Higher absolute values indicate greater emotional intensity. |
| Fetal heart rate baseline measured by Non-Stress Test (NST) | Baseline, immediately after the first intervention session, 1 week after baseline (before the second intervention session), and immediately after completion of the second (final) intervention session | Fetal heart rate baseline will be assessed in beats per minute (bpm) using the Non-Stress Test (NST). |
| Number of fetal heart rate accelerations measured by Non-Stress Test (NST) | Baseline, immediately after the first intervention session, 1 week after baseline (before the second intervention session), and immediately after completion of the second (final) intervention session | The number of fetal heart rate accelerations will be recorded during a Non-Stress Test (NST) over a monitoring period of at least 20 minutes. |
| Presence of fetal heart rate decelerations measured by Non-Stress Test (NST) | Baseline, immediately after the first intervention session, 1 week after baseline (before the second intervention session), and immediately after completion of the second (final) intervention session | The presence or absence of fetal heart rate decelerations will be recorded during a Non-Stress Test (NST). |
| Number of fetal movements measured by Non-Stress Test (NST) | Baseline, immediately after the first intervention session, 1 week after baseline (before the second intervention session), and immediately after completion of the second (final) intervention session | The number of fetal movements will be recorded during a Non-Stress Test (NST) over a monitoring period of at least 20 minutes. |
| NST reactivity status measured by Non-Stress Test (NST) | Baseline, immediately after the first intervention session, 1 week after baseline (before the second intervention session), and immediately after completion of the second (final) intervention session. | NST reactivity will be classified as reactive or non-reactive based on standard clinical criteria. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSüreyya Kılıç, PhD(c)
Outcome results
None listed