Anxiety, Labor Pain
Conditions
Keywords
music therapy, anxiety, pain management, labor, randomized controlled trial
Brief summary
This multicenter randomized controlled trial evaluates the effectiveness of music therapy in reducing pain and anxiety during the latent and active phases of labor in Tunisian women. Participants are randomized to receive either music therapy or standard care. Primary outcomes are pain (VAS) and anxiety (STAI-Y). Secondary outcomes include labor duration, maternal and fetal vital signs, neonatal outcomes, and maternal satisfaction.
Detailed description
This study investigates the impact of music therapy on pain and anxiety management during labor in Tunisian parturients. Given the limited access to pharmacological analgesia in many public maternity units, the trial explores music as a non-pharmacological, low-cost, and patient-centered intervention. Eligible women in labor are randomly assigned to either a music therapy group or a control group receiving standard care. Music is administered during the latent and active phases following established clinical guidelines (slow tempo, non-lyrical, patient-guided selection). The study evaluates changes in pain intensity, anxiety levels, labor progression, maternal-fetal physiological parameters, neonatal outcomes, and maternal satisfaction. Findings aim to inform labor care practices and promote integrative approaches in resource-limited settings.
Interventions
OTHERMusic Therapy During Labor
This intervention involves the use of patient-selected, slow-tempo (60-80 bpm), non-lyrical instrumental music administered via headphones or speakers during the latent and active phases of labor. The music selection is guided to ensure therapeutic suitability (e.g., calming rhythm, absence of lyrics) and is delivered for a minimum of 30 minutes. The intervention is non-pharmacological, individualized, and adheres to WHO and clinical music therapy recommendations. It is distinguished by its personalized music choice, delivery timing, and structured application within labor progression monitoring.
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Married Tunisian women with a singleton, low-risk pregnancy. * Admitted in the latent phase of spontaneous labor, as diagnosed by a midwife or resident. * Planned vaginal delivery. * Parity \< 4. * Gestational age between 37 and 41 weeks of amenorrhea. * Attended at least 4 prenatal consultations. * Normal physical and mental health status. * No known fetal anomalies. * Estimated fetal weight between 2500-4000 g. * Cephalic presentation. * Normal fetal heart rate and uterine contraction tracings. * Able to read, write, and understand study-related information. * Provided written informed consent.
Exclusion criteria
* Women who received epidural analgesia during labor. * Presence of auricular malformations. * Difficulty in understanding or completing the VAS or STAI-Y assessments. * Serious medical or psychiatric disorders. * Multiple gestation or pregnancies requiring immediate intervention. * Preterm (\<37 weeks) or post-term (\>41 weeks) pregnancies. * Premature rupture of membranes. * Clinical chorioamnionitis or other infections (including HIV). * History of severe obstetric complications (e.g., cephalopelvic disproportion, intrauterine fetal death )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | 30 minutes after completing the music session | Pain intensity will be measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 = no pain to 10 = worst imaginable pain. |
| Anxiety level | 30 minutes after completing the music session | Anxiety level will be measured using the State-Trait Anxiety Inventory, Form Y (STAI-Y), with higher scores indicating greater anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal pulse rate | 30 minutes after completing the music session | Maternal pulse rate will be maesured in beat per minute 30 mn after listening to the musioc selection |
| Maternal arterial pressure | 30 minutes after completing the music session | Maternal arterial pressure will be maesured in mmHg |
| Apgar score | 5 minutes after delivery | the foetal pgar score was maesures on a scale from 0 to 10 five minutes after delivery |
| Maternal satisfaction | 2 hours after delivery | Maternal satisfaction was maesured by a likert scale from 1 to 10 2 hours after delivery |
Countries
Tunisia
Contacts
Primary ContactNESRINE SOUAYEH, Associate Professor
Outcome results
None listed