Music InterventionNCT07177027
The Effects of Breathing Exercises and Music Intervention During Labor on Pain Perception, Birth Expectations, and Birth Satisfaction in Primiparous Women
A study testing Music intervention and Breathing Exercise in people with Music Intervention and Breathing Exercises, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to evaluate the effects of music listening and breathing exercises during labor on pain perception, birth expectations, and birth satisfaction among primiparous women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Music Intervention, Breathing Exercises
- What is being tested?
- Music intervention and Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2024to 22 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Participants were included in the study if they met the following criteria:
Voluntary participation in the study and provision of written informed consent, Being a primiparous pregnant woman, Aged between 18 and 35 years, Gestational age between 38 and 42 weeks, Ability to read and write, No hearing impairment that would prevent listening to music, Planning to deliver vaginally, No respiratory disorders (e.g., asthma, COPD) that would interfere with breathing exercises, No obstetric complications that could affect labor progression (e.g., precipitous labor, prolonged labor), Attendance in antenatal childbirth education classes, including learning breathing exercises and listening to the music pieces planned for the intervention.
Not receiving any labor-inducing medications
-
Exclusion Criteria: Participants were excluded if they met any of the following:
Withdrawal of consent or unwillingness to continue cooperation at any stage of the study, Refusal to continue with breathing exercises or music intervention during any phase of labor, Undergoing cesarean section due to medical indications despite initial plan for vaginal delivery, Gestational age outside of 38-42 weeks, Development of labor-related complications such as precipitous or prolonged labor during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uşak University
Uşak, Uşak, 64200
Şeyma ÇATALGÖL, Dr, 05549734720 ext. +9005549734720, seyma.catalgol@usak.edu.tr
Hanefi Özbek, Professor
About this study
Official title: The Effects of Breathing Exercises and Music Intervention During Labor on Pain Perception, Birth Expectations, and Birth Satisfaction in Primiparous Women: A Randomized Controlled Trial
This randomized controlled trial aimed to evaluate the effects of music listening and breathing exercises during labor on pain perception, birth expectations, and birth satisfaction among primiparous women. This randomized controlled trial was conducted in the delivery unit of a hospital located in the Inner Aegean Region of Turkey. The study included 90 primiparous pregnant women admitted for vaginal delivery. Participants without visual, auditory, or neurological impairments were included and randomly assigned into three groups: music intervention group, breathing exercise group, and control group (n=30 in each group).
Participants were randomly assigned to one of three groups (Music Intervention, Breathing Exercise, Control) using a computer-generated randomization sequence. Allocation concealment was ensured by using sealed, opaque envelopes prepared by a researcher who was not involved in participant recruitment or assessment.
Read more
In the music intervention group, participants were introduced to 12 music tracks at 36 weeks of gestation during childbirth preparation classes. Short samples of these tracks were played during the class, and the full tracks were then shared with participants via WhatsApp to encourage regular listening at home.
During the prenatal period, participants received regular WhatsApp reminders every few days to listen to the music.
During labor, participants were encouraged to listen to music whenever they wished. Additionally, at 4 cm, 6 cm, and 8 cm cervical dilation, all participants in this group listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured using the Visual Analog Scale (VAS) before and after each music session.
In the breathing exercise group, Lamaze breathing techniques were taught during prenatal classes and practiced throughout the labor process. They were encouraged to practice these exercises throughout labor. At 4, 6, and 8 cm cervical dilation, guided breathing exercises were conducted, and pain was assessed using the Visual Analog Scale (VAS) before and after each exercise.
In the control group, participants received routine maternity care. VAS pain assessments were conducted at the same cervical dilation points (4, 6, and 8 cm), without any additional interventions.
For all participants, the durations of the first, second, and third stages of labor were recorded and compared across groups. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered.
Study data included sociodemographic information, VAS pain scores, and scores from the birth expectation and satisfaction scales.
Read the detailed description
This randomized controlled trial aimed to evaluate the effects of music listening and breathing exercises during labor on pain perception, birth expectations, and birth satisfaction among primiparous women. The study was conducted in the delivery unit of a hospital in the Inner Aegean Region of Turkey and included 90 healthy primiparous pregnant women admitted for vaginal delivery. Participants who met the inclusion criteria were randomly assigned to one of three groups: music intervention group, breathing exercise group, or control group, with 30 women in each group.
Participants were randomly assigned to one of three groups (Music Intervention, Breathing Exercise, Control) using a computer-generated randomization sequence. Allocation concealment was ensured by using sealed, opaque envelopes prepared by a researcher who was not involved in participant recruitment or assessment.
In the music intervention group, participants attended childbirth preparation classes at 36 weeks of gestation, where they were introduced to 12 carefully selected music tracks. In order to determine the music pieces to be used in the study, a playlist consisting of 36 tracks with varying tempos and emotional content was created. The playlist included an equal number of slow, moderate, and fast-tempo pieces, each further divided into subcategories representing calming, neutral, and uplifting emotional tones.
The selection process involved 20 volunteer pregnant individuals who were not part of the study sample but shared similar demographic characteristics. These volunteers were asked to listen to short excerpts (30-60 seconds) of each track and to identify the 12 pieces they liked the most. Preferences were recorded either through a Likert-type rating form.
To minimize order effects, the music tracks were presented in a randomized sequence. Participants were encouraged to use headphones to reduce environmental distractions and ensure consistent audio quality.
This participant-based music selection approach was designed to enhance emotional and cultural alignment between the selected music and the target population. It also aimed to increase the ecological validity of the intervention by incorporating music preferences that are more likely to elicit genuine emotional and physiological responses.Short samples of each track were played during the class. The full music playlist was shared with each participant via WhatsApp for home listening, and regular reminders were sent every few days to encourage consistent use during the antenatal period. During labor, women were encouraged to listen to music freely. In addition, at 4, 6, and 8 cm of cervical dilation, all participants in this group were asked to listen to their preferred tracks from the playlist for 20 minutes. Pain intensity was evaluated before and after each listening session using the Visual Analog Scale (VAS).
In the breathing exercise group, participants were trained in Lamaze breathing techniques during childbirth preparation classes and were encouraged to apply these techniques throughout labor. At 4, 6, and 8 cm cervical dilation, structured breathing exercises were performed, and pain was assessed before and after each session using the VAS.
The control group received routine maternity care without any additional non-pharmacological interventions. However, VAS pain assessments were still conducted at 4, 6, and 8 cm cervical dilation for comparison.
The duration of the first, second, and third stages of labor was recorded for all participants. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered to assess maternal perspectives and satisfaction with the birth experience.
Study data were collected using a sociodemographic data form, VAS for pain assessment, and validated scales for measuring birth expectations and satisfaction. The results of this study may inform the use of non-pharmacological interventions to improve maternal comfort and the childbirth experience in clinical practice.
- Conditions
- Music Intervention, Breathing Exercises
- Being tested
- Music intervention, Breathing Exercise
- Keywords
- Music intervention, Breathing exercises, Birth, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Participants listened to 12 relaxing music tracks introduced during prenatal childbirth classes at 36 weeks of gestation. The tracks were shared via WhatsApp to encourage regular listening during pregnancy. During labor, participants were encouraged to listen to music whenever they wished. At cervical dilations of 4 cm, 6 cm, and 8 cm, participants listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured before and after each session using the Visual Analog Scale (VAS).
Breathing ExerciseBehavioural
Participants were trained in Lamaze breathing techniques during prenatal childbirth classes. They practiced guided breathing exercises during labor at cervical dilation points of 4 cm, 6 cm, and 8 cm. Pain intensity was assessed before and after each session using the Visual Analog Scale (VAS).
| Study group | Role | What they receive |
|---|---|---|
| Music intervention group | Experimental | In the music intervention group, participants were introduced to 12 music tracks at 36 weeks of gestation during childbirth preparation classes. Short samples of these tracks were played during the class, and the full tracks were then shared with participants via WhatsApp to encourage regular listening at home.
During the prenatal period, participants received regular WhatsApp reminders every few days to listen to the music.
During labor, participants were encouraged to listen to music whenever they wished. Additionally, at 4 cm, 6 cm, and 8 cm cervical dilation, all participants in this group listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured using the Visual Analog Scale (VAS) before and after each music session. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered. Receives: Behavioral: Music intervention |
| Breathing Exercises Group | Experimental | In the breathing exercise group, Lamaze breathing techniques were taught during prenatal classes and practiced throughout the labor process. They were encouraged to practice these exercises throughout labor. At 4, 6, and 8 cm cervical dilation, guided breathing exercises were conducted, and pain was assessed using the Visual Analog Scale (VAS) before and after each exercise. Receives: Behavioral: Breathing Exercise |
| Control Group | No intervention | In the control group, participants received routine maternity care. VAS pain assessments were conducted at the same cervical dilation points (4, 6, and 8 cm), without any additional interventions. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity During Labor
Measurement Tool: Visual Analog Scale (VAS), 0-10 Description: Pain intensity will be assessed before and after each intervention session (music or breathing exercises) at specified cervical dilations. In the control group, VAS will be measured at the same points without intervention.
Primary Purpose: To determine the effect of music and breathing interventions on perceived pain intensity during labor.
Measured: At 4 cm, 6 cm, and 8 cm cervical dilation during active labor
Duration of Labor Stages
The duration (in minutes) of each labor stage will be recorded and compared between the three groups (music, breathing, and control).
Measured: During the first, second, and third stages of labor
Secondary outcomes (2)
Within 6-12 hours postpartum
Measurement Tool: Birth Expectation Scale Evaluates whether the birth experience met the woman's expectations, measured after delivery.
Measured: Within 6-12 hours postpartum
Birth Satisfaction Score
Measurement Tool: Birth Satisfaction Scale , assesses overall maternal satisfaction with the birth experience.
Measured: Within 6-12 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start3 Dec 2024
- Primary completion22 Sep 2025 (estimated)
- Study completion22 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Çatalgöl, Uşak University
- Investigators
- Şeyma ÇATALGÖL, Dr, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177027
- Sponsor's protocol ID
- 480-480-27
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Breathing Exercises and Music Intervention During Labor on Pain Perception, Birth Expectations, and Birth Satisfaction in Primiparous Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07177027
- Acronym / sponsor ID
- 480-480-27
- Conditions
- Music Intervention, Breathing Exercises
- Keywords
- Music intervention, Breathing exercises, Birth, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 22 Sep 2025 (estimated)
- Study completion
- 22 Sep 2025 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aimed to evaluate the effects of music listening and breathing exercises during labor on pain perception, birth expectations, and birth satisfaction among primiparous women. This randomized controlled trial was conducted in the delivery unit of a hospital located in the Inner Aegean Region of Turkey. The study included 90 primiparous pregnant women admitted for vaginal delivery. Participants without visual, auditory, or neurological impairments were included and randomly assigned into three groups: music intervention group, breathing exercise group, and control group (n=30 in each group).
Participants were randomly assigned to one of three groups (Music Intervention, Breathing Exercise, Control) using a computer-generated randomization sequence. Allocation concealment was ensured by using sealed, opaque envelopes prepared by a researcher who was not involved in participant recruitment or assessment.
In the music intervention group, participants were introduced to 12 music tracks at 36 weeks of gestation during childbirth preparation classes. Short samples of these tracks were played during the class, and the full tracks were then shared with participants via WhatsApp to encourage regular listening at home.
During the prenatal period, participants received regular WhatsApp reminders every few days to listen to the music.
During labor, participants were encouraged to listen to music whenever they wished. Additionally, at 4 cm, 6 cm, and 8 cm cervical dilation, all participants in this group listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured using the Visual Analog Scale (VAS) before and after each music session.
In the breathing exercise group, Lamaze breathing techniques were taught during prenatal classes and practiced throughout the labor process. They were encouraged to practice these exercises throughout labor. At 4, 6, and 8 cm cervical dilation, guided breathing exercises were conducted, and pain was assessed using the Visual Analog Scale (VAS) before and after each exercise.
In the control group, participants received routine maternity care. VAS pain assessments were conducted at the same cervical dilation points (4, 6, and 8 cm), without any additional interventions.
For all participants, the durations of the first, second, and third stages of labor were recorded and compared across groups. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered.
Study data included sociodemographic information, VAS pain scores, and scores from the birth expectation and satisfaction scales.
Detailed description
This randomized controlled trial aimed to evaluate the effects of music listening and breathing exercises during labor on pain perception, birth expectations, and birth satisfaction among primiparous women. The study was conducted in the delivery unit of a hospital in the Inner Aegean Region of Turkey and included 90 healthy primiparous pregnant women admitted for vaginal delivery. Participants who met the inclusion criteria were randomly assigned to one of three groups: music intervention group, breathing exercise group, or control group, with 30 women in each group.
Participants were randomly assigned to one of three groups (Music Intervention, Breathing Exercise, Control) using a computer-generated randomization sequence. Allocation concealment was ensured by using sealed, opaque envelopes prepared by a researcher who was not involved in participant recruitment or assessment.
In the music intervention group, participants attended childbirth preparation classes at 36 weeks of gestation, where they were introduced to 12 carefully selected music tracks. In order to determine the music pieces to be used in the study, a playlist consisting of 36 tracks with varying tempos and emotional content was created. The playlist included an equal number of slow, moderate, and fast-tempo pieces, each further divided into subcategories representing calming, neutral, and uplifting emotional tones.
The selection process involved 20 volunteer pregnant individuals who were not part of the study sample but shared similar demographic characteristics. These volunteers were asked to listen to short excerpts (30-60 seconds) of each track and to identify the 12 pieces they liked the most. Preferences were recorded either through a Likert-type rating form.
To minimize order effects, the music tracks were presented in a randomized sequence. Participants were encouraged to use headphones to reduce environmental distractions and ensure consistent audio quality.
This participant-based music selection approach was designed to enhance emotional and cultural alignment between the selected music and the target population. It also aimed to increase the ecological validity of the intervention by incorporating music preferences that are more likely to elicit genuine emotional and physiological responses.Short samples of each track were played during the class. The full music playlist was shared with each participant via WhatsApp for home listening, and regular reminders were sent every few days to encourage consistent use during the antenatal period. During labor, women were encouraged to listen to music freely. In addition, at 4, 6, and 8 cm of cervical dilation, all participants in this group were asked to listen to their preferred tracks from the playlist for 20 minutes. Pain intensity was evaluated before and after each listening session using the Visual Analog Scale (VAS).
In the breathing exercise group, participants were trained in Lamaze breathing techniques during childbirth preparation classes and were encouraged to apply these techniques throughout labor. At 4, 6, and 8 cm cervical dilation, structured breathing exercises were performed, and pain was assessed before and after each session using the VAS.
The control group received routine maternity care without any additional non-pharmacological interventions. However, VAS pain assessments were still conducted at 4, 6, and 8 cm cervical dilation for comparison.
The duration of the first, second, and third stages of labor was recorded for all participants. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered to assess maternal perspectives and satisfaction with the birth experience.
Study data were collected using a sociodemographic data form, VAS for pain assessment, and validated scales for measuring birth expectations and satisfaction. The results of this study may inform the use of non-pharmacological interventions to improve maternal comfort and the childbirth experience in clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music intervention group | Experimental | Behavioral: Music interventionIn the music intervention group, participants were introduced to 12 music tracks at 36 weeks of gestation during childbirth preparation classes. Short samples of these tracks were played during the class, and the full tracks were then shared with participants via WhatsApp to encourage regular listening at home. During the prenatal period, participants received regular WhatsApp reminders every few days to listen to the music. During labor, participants were encouraged to listen to music whenever they wished. Additionally, at 4 cm, 6 cm, and 8 cm cervical dilation, all participants in this group listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured using the Visual Analog Scale (VAS) before and after each music session. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered. |
| Breathing Exercises Group | Experimental | Behavioral: Breathing ExerciseIn the breathing exercise group, Lamaze breathing techniques were taught during prenatal classes and practiced throughout the labor process. They were encouraged to practice these exercises throughout labor. At 4, 6, and 8 cm cervical dilation, guided breathing exercises were conducted, and pain was assessed using the Visual Analog Scale (VAS) before and after each exercise. |
| Control Group | No intervention | –In the control group, participants received routine maternity care. VAS pain assessments were conducted at the same cervical dilation points (4, 6, and 8 cm), without any additional interventions. In the postpartum period, the Birth Expectation Scale and Birth Satisfaction Scale were administered. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionParticipants listened to 12 relaxing music tracks introduced during prenatal childbirth classes at 36 weeks of gestation. The tracks were shared via WhatsApp to encourage regular listening during pregnancy. During labor, participants were encouraged to listen to music whenever they wished. At cervical dilations of 4 cm, 6 cm, and 8 cm, participants listened to their preferred tracks from the playlist for 20 minutes. Pain intensity was measured before and after each session using the Visual Analog Scale (VAS). | Behavioural | Music intervention group |
| Breathing ExerciseParticipants were trained in Lamaze breathing techniques during prenatal childbirth classes. They practiced guided breathing exercises during labor at cervical dilation points of 4 cm, 6 cm, and 8 cm. Pain intensity was assessed before and after each session using the Visual Analog Scale (VAS). | Behavioural | Breathing Exercises Group |
Primary outcome
Change in Pain Intensity During Labor
Time frame: At 4 cm, 6 cm, and 8 cm cervical dilation during active labor
Measurement Tool: Visual Analog Scale (VAS), 0-10 Description: Pain intensity will be assessed before and after each intervention session (music or breathing exercises) at specified cervical dilations. In the control group, VAS will be measured at the same points without intervention. Primary Purpose: To determine the effect of music and breathing interventions on perceived pain intensity during labor.
Duration of Labor Stages
Time frame: During the first, second, and third stages of labor
The duration (in minutes) of each labor stage will be recorded and compared between the three groups (music, breathing, and control).
2 secondary outcomes
Within 6-12 hours postpartum
Time frame: Within 6-12 hours postpartum
Birth Satisfaction Score
Time frame: Within 6-12 hours postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Music Intervention
Not yet recruiting
Music Listening for Chronic Pain in Adults With Early-Stage Dementia
Chronic Pain, Alzheimer Disease
Recruiting
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
Anxiety, Osteoarthritis
Recruiting
Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery
Diabetes Type 2
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
Not yet recruiting
Music for Reducing Anxiety Before Surgery
Preoperative Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Şeyma ÇATALGÖL, Dr principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention and Breathing Exercise in people with Music Intervention and Breathing Exercises, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şeyma ÇATALGÖL, Dr (+905549734720 ext. +9005549734720, seyma.catalgol@usak.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity During Labor (time frame: At 4 cm, 6 cm, and 8 cm cervical dilation during active labor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.