Music Therapy for Labor Pain and Anxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity Tunis El Manar
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Music Therapy During Labor
Other interventionThis 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Music groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain level
Pain intensity will be measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 = no pain to 10 = worst imaginable pain.
Time frame
30 minutes after completing the music session2
Anxiety level
Anxiety level will be measured using the State-Trait Anxiety Inventory, Form Y (STAI-Y), with higher scores indicating greater anxiety.
Time frame
30 minutes after completing the music sessionSecondary outcomes
1
Maternal pulse rate
Maternal pulse rate will be maesured in beat per minute 30 mn after listening to the musioc selection
Time frame
30 minutes after completing the music session2
Maternal arterial pressure
Maternal arterial pressure will be maesured in mmHg
Time frame
30 minutes after completing the music session3
Apgar score
the foetal pgar score was maesures on a scale from 0 to 10 five minutes after delivery
Time frame
5 minutes after delivery4
Maternal satisfaction
Maternal satisfaction was maesured by a likert scale from 1 to 10 2 hours after delivery
Time frame
2 hours after deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: