Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy

Официальное название

The Effect of Emotional Freedom Technique and Music Therapy Applied to High-Risk Pregnant Women on Maternal Psychological Status, Coping Methods, and Non-Stress Test Findings: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Emotional 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 th
• Поведенческое Music 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 res

Первичные конечные точки

• Depression Anxiety Stress Scale-21 (DASS-21) [Срок оценки: Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period]

Вторичные конечные точки (7)

• Coping Responses Inventory (CRI) [Срок оценки: Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period]
• Subjective Units of Experience-SUE [Срок оценки: 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]
• Fetal heart rate baseline measured by Non-Stress Test (NST) [Срок оценки: 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]
• Number of fetal heart rate accelerations measured by Non-Stress Test (NST) [Срок оценки: 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]
• Presence of fetal heart rate decelerations measured by Non-Stress Test (NST) [Срок оценки: 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]
• Number of fetal movements measured by Non-Stress Test (NST) [Срок оценки: 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 status measured by Non-Stress Test (NST) [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07559071 · SU-EFTMT-HRP-2026-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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