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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSelcuk University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Emotional Freedom Technique (EFT)

    Behavioral

    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.

  • Music Therapy

    Behavioral

    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.

Treatment groups

177 Participants
are divided into 3 treatment groups
Group A: Emotional Freedom Technique (EFT) GroupExperimental treatment 1 intervention
Group B: Music TherapyExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Depression Anxiety Stress Scale-21 (DASS-21)

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.

Time frame
Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period

Secondary outcomes

1

Coping Responses Inventory (CRI)

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.

Time frame
Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period
2

Subjective Units of Experience-SUE

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.

Time frame
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
3

Fetal heart rate baseline measured by Non-Stress Test (NST)

Fetal heart rate baseline will be assessed in beats per minute (bpm) using the Non-Stress Test (NST).

Time frame
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
4

Number of fetal heart rate accelerations measured by Non-Stress Test (NST)

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.

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.