Ben Arous regional Hospital
Ben Arous, 2096, Tunisia
Location contact
NESRINE SOUAYEH, Associate Professor
CONTACT
97816168 ext. +216
Oumaima Marzouki, Master's Student
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07139574
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
Ben Arous, 2096, Tunisia
NESRINE SOUAYEH, Associate Professor
CONTACT
97816168 ext. +216
Oumaima Marzouki, Master's Student
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 30 minutes after completing the music session
Maternal arterial pressure will be maesured in mmHg
Time frame: 5 minutes after delivery
the foetal pgar score was maesures on a scale from 0 to 10 five minutes after delivery
Time frame: 2 hours after delivery
Maternal satisfaction was maesured by a likert scale from 1 to 10 2 hours after delivery
Contact information is provided by the study sponsor or research team.
University Tunis El Manar
Other
Impact of Music Therapy on Labor Pain and Anxiety: A Randomized Controlled Trial in Tunisian Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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