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Preterm Premature Rupture of Membranes (PPROM)NCT07559071

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

A study testing Emotional Freedom Technique (EFT) and Music Therapy in people with Preterm Premature Rupture of Membranes (PPROM) and Premature Rupture of Membranes (PROM), run by Selcuk University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Emotional Freedom Technique (EFT) and Music Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Süreyya Kılıç, PhD(c) contact

+90 501 578 99 08

sureyyakilic117@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Konya City Hospital

    Konya, Konya, 42020

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Emotional Freedom Technique (EFT), Music Therapy
Keywords
Emotional Freedom Technique, Music Therapy, High-Risk Pregnancy, PPROM, Maternal Mental Health, Anxiety, Depression, Stress, Coping Strategies, Non-Stress Test, Fetal Well-Being
Medical subject headings
Preterm Premature Rupture of the Membranes, Fetal Membranes, Premature Rupture, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Freedom Technique (EFT)Behavioural

    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 TherapyBehavioural

    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.

Study groups in NCT07559071
Study groupRoleWhat they receive
Emotional Freedom Technique (EFT) GroupExperimentalParticipants 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.
Receives: Behavioral: Emotional Freedom Technique (EFT)
Music TherapyExperimentalParticipants 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.
Receives: Behavioral: Music Therapy
Control GroupNo interventionParticipants in this group will receive routine clinical care without any additional intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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

  5. Presence of fetal heart rate decelerations measured by Non-Stress Test (NST)

    The presence or absence of fetal heart rate decelerations will be recorded during a Non-Stress Test (NST).

    Measured: 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

  6. Number of fetal movements measured by Non-Stress Test (NST)

    The number of fetal movements will be recorded during a Non-Stress Test (NST) over a monitoring period of at least 20 minutes.

    Measured: 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

  7. NST reactivity status measured by Non-Stress Test (NST)

    NST reactivity will be classified as reactive or non-reactive based on standard clinical criteria.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2026
  2. Study start1 Jun 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of three parallel groups: Emotional Freedom Technique (EFT), music therapy, or a control group receiving routine care. Each participant will receive only one type of intervention, and outcomes will be assessed and compared between groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
177 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07559071
Sponsor's protocol ID
SU-EFTMT-HRP-2026-001
Status last verified
Sep 2026
First submitted
18 Apr 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared in order to ensure participant confidentiality and data security, in accordance with ethical an

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Freedom Technique (EFT) and Music Therapy in people with Preterm Premature Rupture of Membranes (PPROM) and Premature Rupture of Membranes (PROM), run by Selcuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Süreyya Kılıç, PhD(c) (+90 501 578 99 08, sureyyakilic117@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Anxiety Stress Scale-21 (DASS-21) (time frame: Baseline and immediately after completion of the second (final) intervention session following a 1-week self-practice period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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