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

NCT07559071 | Not Yet Recruiting

• 1 other identifier: SU-EFTMT-HRP-2026-001
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Preterm Premature Rupture of Membranes (PPROM); High-Risk Pregnancy; Premature Rupture of Membranes (PROM)

Keywords

Emotional Freedom Technique; Music Therapy; High-Risk Pregnancy; PPROM; Maternal Mental Health; Anxiety; Depression; Stress; Coping Strategies; Non-Stress Test; Fetal Well-Being

Outcome Measures

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.

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

Secondary Outcomes (7)

• Coping Responses Inventory (CRI)

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

• Subjective Units of Experience-SUE

  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)

  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)

  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)

  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

Study Arms (3)

Emotional Freedom Technique (EFT) Group

EXPERIMENTAL

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.

Behavioral: Emotional Freedom Technique (EFT)

Music Therapy

EXPERIMENTAL

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.

Behavioral: Music Therapy

Control Group

NO INTERVENTION

Participants in this group will receive routine clinical care without any additional intervention.

Interventions

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.

Emotional Freedom Technique (EFT) Group

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.

Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Fetal Membranes, Premature Rupture; Anxiety Disorders; Depression

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Süreyya Kılıç, PhD(c)

CONTACT

+90 501 578 99 08; sureyyakilic117@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The non-stress test (NST) findings will be evaluated by an obstetrician who is blinded to group allocation. In addition, statistical analyses will be conducted by a statistician who is blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Midwife, PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share