The Effects of Epidural Analgesia on Maternal-Infant Bonding and Birth-Related Trauma

ConditionEpidural Anesthesia in Labor and Delivery

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorAdiyaman University Research Hospital

About this trial

This prospective, single-center study aims to evaluate the effects of epidural analgesia on maternal-infant bonding and perceived birth-related trauma in women undergoing vaginal delivery. Participants will be divided into two groups: those who receive epidural analgesia and those who deliver without it. Standardized questionnaires will be used to assess pain perception, maternal satisfaction, and the quality of early bonding between mother and infant. The study is designed in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, with approval from the local ethics committee.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Epidural Analgesia
Procedure/Surgery
After informed consent and exclusion of contraindications, an epidural catheter will be placed at the L3-L4 interspace in the sitting position using a Tuohy needle. A test dose of 2 mL lidocaine will be administered to confirm correct catheter placement under continuous monitoring of vital signs. Once cervical dilatation reaches 5 cm, 5 mL of 0.2% bupivacaine combined with 25 mcg fentanyl will be administered via the epidural catheter. Additional boluses will be given as needed based on pain assessment. The catheter will be removed 24 hours postpartum.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Epidural group- group EExperimental treatment 1 intervention

Group B: Control group- group CNo intervention 0 interventions

Trial outcomes

Primary outcomes

Effect of Epidural Analgesia on Maternal-Infant Bonding Quality and Birth-Related Psychological Stress

Assessment of maternal-infant bonding quality using the Maternal Attachment Inventory (MAI) and evaluation of birth-related psychological stress using a validated childbirth trauma scale. Outcomes will be measured via structured questionnaires administered at 1 month postpartum to evaluate the psychological impact of epidural analgesia during vaginal delivery.

Time frame

1 month postpartum

Secondary outcomes

Pain Intensity During Labor Assessed by Visual Analog Scale (VAS)

Evaluation of maternal pain intensity during labor using the Visual Analog Scale (VAS). Pain scores will be recorded at predefined intervals, including active labor and immediately postpartum.

Time frame

From labor onset until discharge (approximately 0 to 48 hours postpartum)

Other outcomes

Maternal Satisfaction with the Birth Experience

Assessment of maternal satisfaction regarding the childbirth process using a validated satisfaction questionnaire administered prior to hospital discharge.

Time frame

Within 48 hours postpartum (prior to discharge)

Sponsors and contacts

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Adiyaman University Research Hospital

Lead sponsor

Source ClinicalTrials.gov

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