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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music group | Experimental | The intervention consists of music therapy administered during the latent and active phases of labor. Music is delivered through headphones or speakers and includes slow, instrumental, non-lyrical tracks (60-80 beats per minute), selected in collaboration with the participant. The intervention is applied for a minimum duration of 30 minutes and follows established clinical guidelines for therapeutic music use. Standard monitoring of maternal and fetal well-being is maintained throughout the intervention. |
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| Control Group | No Intervention | This group received routine care during labor (monitoring of labor progression, vital signs, and fetal heart rate monitoring). No specific pain management techniques were used for this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Therapy During Labor | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes after completing the music session |
| Anxiety level | Anxiety level will be measured using the State-Trait Anxiety Inventory, Form Y (STAI-Y), with higher scores indicating greater anxiety. | 30 minutes after completing the music session |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal pulse rate | Maternal pulse rate will be maesured in beat per minute 30 mn after listening to the musioc selection | 30 minutes after completing the music session |
| Maternal arterial pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NESRINE SOUAYEH, Associate Professor | Contact | 97816168 | +216 | nesrine.souayeh@fmt.utm.tn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Arous regional Hospital | Ben Arous | 2096 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40346658 | Result | Vaid R, Fareed A, Farhat S, Hammoud Z, Asif MI, Ochani S, Jaber MH. Sounds of comfort: the impact of music therapy on labor pain and anxiety in primigravida women during vaginal delivery: a systematic review and meta-analysis. Reprod Health. 2025 May 9;22(1):67. doi: 10.1186/s12978-025-02023-z. | |
| 33050409 | Result |
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Individual participant data (IPD) will not be shared because of concerns regarding patient confidentiality and the absence of institutional infrastructure for secure data sharing.
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D001008 | Anxiety Disorders |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Maternal arterial pressure will be maesured in mmHg
| 30 minutes after completing the music session |
| Apgar score | the foetal pgar score was maesures on a scale from 0 to 10 five minutes after delivery | 5 minutes after delivery |
| Maternal satisfaction | Maternal satisfaction was maesured by a likert scale from 1 to 10 2 hours after delivery | 2 hours after delivery |
| Santivanez-Acosta R, Tapia-Lopez ELN, Santero M. Music Therapy in Pain and Anxiety Management during Labor: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Oct 10;56(10):526. doi: 10.3390/medicina56100526. |
| 35600844 | Result | Guo H, Que M, Shen J, Nie Q, Chen Y, Huang Q, Jin A. Effect of Music Therapy Combined with Free Position Delivery on Labor Pain and Birth Outcomes. Appl Bionics Biomech. 2022 May 11;2022:8963656. doi: 10.1155/2022/8963656. eCollection 2022. |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |