- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Süreyya Kılıç, PhD(c)
- 전화번호: +90 501 578 99 08
- 이메일: sureyyakilic117@gmail.com
연구 장소
-
-
Konya
-
Konya, Konya, 터키 (Türkiye), 42020
- 모병
- Konya City Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
|
실험적: 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.
|
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.
|
|
간섭 없음: Control Group
Participants in this group will receive routine clinical care without any additional intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depression Anxiety Stress Scale-21 (DASS-21)
기간: 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.
|
Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Coping Responses Inventory (CRI)
기간: 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.
|
Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period
|
|
Subjective Units of Experience-SUE
기간: 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.
|
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)
기간: 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).
|
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)
기간: 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.
|
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)
기간: 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).
|
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)
기간: 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.
|
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)
기간: 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.
|
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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SU-EFTMT-HRP-2026-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .