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- Ensayo clínico NCT07559071
Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy
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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Süreyya Kılıç, PhD(c)
- Número de teléfono: +90 501 578 99 08
- Correo electrónico: sureyyakilic117@gmail.com
Ubicaciones de estudio
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Konya
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Konya, Konya, Turquía (Türkiye), 42020
- Reclutamiento
- Konya City Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Emotional Freedom Technique (EFT) Group
Participants in this group will receive Emotional Freedom Technique (EFT) sessions in addition to routine care.
EFT will be applied by the researcher in two sessions, and participants will be instructed to practice EFT daily for one week.
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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.
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Experimental: Music Therapy
Participants in this group will receive music therapy in addition to routine care.
Music therapy will be administered in two sessions, and participants will be asked to listen to a standardized music recording daily for one week.
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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.
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Sin intervención: Control Group
Participants in this group will receive routine clinical care without any additional intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Depression Anxiety Stress Scale-21 (DASS-21)
Periodo de tiempo: Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period
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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.
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Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Coping Responses Inventory (CRI)
Periodo de tiempo: Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period
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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.
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Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period
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Subjective Units of Experience-SUE
Periodo de tiempo: 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
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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.
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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
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Fetal heart rate baseline measured by Non-Stress Test (NST)
Periodo de tiempo: 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
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Fetal heart rate baseline will be assessed in beats per minute (bpm) using the Non-Stress Test (NST).
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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
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Number of fetal heart rate accelerations measured by Non-Stress Test (NST)
Periodo de tiempo: 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
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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.
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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
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Presence of fetal heart rate decelerations measured by Non-Stress Test (NST)
Periodo de tiempo: 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
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The presence or absence of fetal heart rate decelerations will be recorded during a Non-Stress Test (NST).
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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
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Number of fetal movements measured by Non-Stress Test (NST)
Periodo de tiempo: 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
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The number of fetal movements will be recorded during a Non-Stress Test (NST) over a monitoring period of at least 20 minutes.
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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
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NST reactivity status measured by Non-Stress Test (NST)
Periodo de tiempo: 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.
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NST reactivity will be classified as reactive or non-reactive based on standard clinical criteria.
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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.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Desordenes mentales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones obstétricas del parto
- Complicaciones del embarazo
- Síntomas de comportamiento
- Comportamiento
- Membranas Fetales, Rotura Prematura
- Desórdenes de ansiedad
- Depresión
- Ruptura Prematura Prematura de Membranas
- Terapéutica
- Terapias complementarias
- Atención al paciente
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapias de arte sensorial
- Musicoterapia
Otros números de identificación del estudio
- SU-EFTMT-HRP-2026-001
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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