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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Study sites: 0 to 1
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07559071
Lead Sponsor Selcuk University
Conditions
(from sponsor)
Preterm Premature Rupture of Membranes (PPROM), Premature Rupture of Membranes (PROM), High-Risk Pregnancy
Related terms [OBSOLETE] Preterm Premature Rupture of the Membranes, Anxiety Disorders, Depression, Premature Rupture of Fetal Membranes
Enrollment 177 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov