AnxietyNCT06969105
Music Use in Parturients Admitted to Labor & Delivery
A study testing Music in people with Anxiety and Pain, run by Tufts Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if music use affects anxiety or pain levels in parturients admitted to labor and delivery. It will also learn about the effect of music use on patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Patient Satisfaction
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to May 2027
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Laboring parturients or those scheduled for an induction of labor
- Able to provide informed consent
- American Society of Anesthesiologists (ASA) physical status rating of II-III
Who cannot join
- Patient refusal
- Impaired hearing
- Patient is taking at least one anxiolytic medication daily at baseline
- Intrauterine fetal demise
- Severe psychiatric disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Dan Drzymalski, Medical Doctor, 617-913-8168, ddrzymalski@tuftsmedicalcenter.org
About this study
Official title: A Randomized Controlled Trial of Music Use in Parturients Admitted to Labor & Delivery
The goal of this clinical trial is to learn if music use affects anxiety or pain levels in parturients admitted to labor and delivery. It will also learn about the effect of music use on patient satisfaction. The main questions it aims to answer are:
Does music use affect anxiety levels in parturients admitted to labor and delivery? Does music use affect pain levels in parturients admitted to labor and delivery? Does music use affect patient satisfaction in parturients admitted to labor and delivery?
Read more
Researchers will compare music to a control (no music) to see if music affects anxiety levels in parturients admitted to labor and delivery.
Participants will:
Listen to music or listen to no music for a 10 minute duration in the labor and delivery unit.
Answer questions about anxiety and pain levels at a few different timepoints. Have information collected from medical charts (vital signs and cervical dilation).
Rate their satisfaction with care.
Read the detailed description
Subjects will be asked their preferred music choice before they are randomly assigned to either the intervention music group, or the no music control group.
The study's active intervention group will be listening to the subject's preferred music for a duration of 10 minutes. The subjects will listen to their preferred music choice played from a speaker connected to an audio device, both supplied by the research team. The investigator and the patient will collaborate on patient positioning of the audio device for sound to optimize comfort and safety during the study intervention. Researchers will confirm the volume of the music and assess subject's comfort before leaving the room for 10 minutes while they listen to music. Subjects must turn off all other noises such as television, other music being played, phone calls ringer/vibration, and texting notifications will be turned off prior to initiation of the study. Phone calls and texting may be left on for subject's who request this. The study team will wait outside the door for 10 minutes, before re-entering. Nursing and providers essential to care will be notified that the subject is participating in the study to ensure no one enters the room unless medically necessary or in case of emergency during this 10-minute time period.
The Control group will not listen to music. The study team will still leave the room for 10 minutes and then re-enter to continue collecting data at each of the time points as below:
Before the intervention begins, researchers will collect from all parturient subjects' their anxiety score (on a scale of 0-10, with 0 being no anxiety), ask them to complete the STAI questionnaires on paper to collect their scores (submitted) and pain score, and record the time data was collected. Researchers will also record clinical data from the EMR for the parturient subject or ask the nurses for the data at the time they take these readings (see Data Collection Form).
If parturient subjects request labor analgesia and have an epidural catheter placed, researchers will collect the same data from parturient subjects both at the time that the request is made and within 30 minutes of the catheter being placed. The data collected from these two timepoints is an optional component of the study (see Informed Consent Form). The subjects can consent ahead of time in the ICF but may withdraw consent for these 2 data points and still be in the rest of the study as the data collected at these 2 timepoints are secondary objectives to explore. If a member of the research team is not in the room at the time this happens, researchers will not collect Anxiety, STAI or pain score and will only collect what is available from the charts, as per the Data Collection Form.
After the intervention (or time has passed, if they are in the control group), the same information will be collected from all participants a second time (see Data Collection Form). Parturient satisfaction will be recorded (Data Collection Form). Nurses on the subject's normal care team will be asked to assist with collecting the vitals for the data collection forms.
All procedures are occurring for research purposes only. Initial vitals collected will be done as per standard care and data will only be pulled later from charts or researchers will ask the nurses for the information as they are collecting it. Later vitals collected, if done at a time where they are not being collected for standard care, will be collected for research only - by the standard care team nurses.
- Conditions
- Anxiety, Pain, Patient Satisfaction
- Being tested
- Music
- Keywords
- music, labor and delivery, parturients, anxiety, analgesia, anesthesia, pain, epidural
- Medical subject headings
- Anxiety Disorders, Pain, Patient Satisfaction, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Prior to randomization, all participants will pre-select their preferred music genre. If randomized to the music group, their preferred music genre will be played for a 10 minute duration.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | Subjects randomized to this arm will listen to music for a 10 minute duration. Receives: Other: Music |
| Control Group | No intervention | Subjects randomized to this arm will not listen to music for a 10 minute duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety will be assessed in two ways. The first using a 0-10 numeric rating scale in which subjects rate their self-perceived anxiety level on this scale. Secondly, they will answer survey questions on the State-Trait Anxiety Inventory questionnaire.
Measured: Baseline and 0 hours post-intervention
Secondary outcomes (10)
Pain Level
Pain will be assessed on a 0-10 numeric rating scale in which subjects rate their self-perceived level of pain.
Measured: Baseline to 0 hours post-intervention
Patient Satisfaction
Patient satisfaction will be assessed using a survey question asking how satisfied the patient is with their care. Subject will rate their satisfaction level as very poor, somewhat poor, average, satisfied, or very satisfied.
Measured: 0 hours post-intervention
Anxiety
Anxiety levels will be assessed using a 0-10 numerical rating scale and on the State Trait Anxiety Inventory questionnaire. Subject will rate their self-perceived anxiety level and answer survey questions.
Measured: Request of labor analgesia and 0,1 hour post-epidural catheter placement
Pain Level
Pain will be assessed using a 0-10 numerical rating scale. Subject will rate their self-perceived pain level on this scale.
Measured: Request of labor analgesia and 0,1 hours post-epidural catheter placement
Blood Pressure
Blood pressure will be recorded in units of millimeters of mercury (mmHg) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.
Measured: Request of labor analgesia and 0,1 hours post-epidural catheter placement
Heart Rate
Heart rate will be recorded in units of beats per minute (bpm) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.
Measured: Request of labor analgesia and 0,1 hours post-epidural catheter placement
Oxygen Saturation
Oxygen saturation will be recorded as a percentage (SpO2) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.
Measured: Request of labor analgesia and 0,1 hours post-epidural catheter placement
Blood Pressure
Blood pressure will be recorded in units of millimeters of mercury (mmHg) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.
Measured: Baseline to 0 hours post-intervention
Oxygen Saturation
Oxygen saturation will be recorded as a percentage (SpO2) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.
Measured: Baseline to 0 hours post-intervention
Heart Rate
Heart rate will be recorded in units of beats per minute (bpm) from an automated vital signs monitor that the patient will already be monitored on upon arrival to the unit.
Measured: Baseline to 0 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start30 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Model description
- One group will listen to music (intervention) and the other group will not listen to music (control).
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969105
- Sponsor's protocol ID
- STUDY00005897
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tabarro CS, de Campos LB, Galli NO, Novo NF, Pereira VM. [Effect of the music in labor and newborn]. Rev Esc Enferm USP. 2010 Jun;44(2):445-52. doi: 10.1590/s0080-62342010000200029. Portuguese.
PubMed 20642059Phumdoung S, Good M. Music reduces sensation and distress of labor pain. Pain Manag Nurs. 2003 Jun;4(2):54-61. doi: 10.1016/s1524-9042(02)54202-8.
PubMed 12836149Simavli S, Gumus I, Kaygusuz I, Yildirim M, Usluogullari B, Kafali H. Effect of music on labor pain relief, anxiety level and postpartum analgesic requirement: a randomized controlled clinical trial. Gynecol Obstet Invest. 2014;78(4):244-50. doi: 10.1159/000365085. Epub 2014 Sep 16.
PubMed 25227477Santivanez-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.
PubMed 33050409Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x.
PubMed 20492051Koch ME, Kain ZN, Ayoub C, Rosenbaum SH. The sedative and analgesic sparing effect of music. Anesthesiology. 1998 Aug;89(2):300-6. doi: 10.1097/00000542-199808000-00005.
PubMed 9710387Hosseini SE, Bagheri M, Honarparvaran N. Investigating the effect of music on labor pain and progress in the active stage of first labor. Eur Rev Med Pharmacol Sci. 2013 Jun;17(11):1479-87.
PubMed 23894767Fong TM, Drzymalski DM. The 95% Effective Duration of Music for Anxiolysis Before Elective Cesarean Delivery. A A Pract. 2025 Feb 28;19(3):e01931. doi: 10.1213/XAA.0000000000001931. eCollection 2025 Mar 1.
PubMed 40019185Drzymalski DM, Tsen LC, Palanisamy A, Zhou J, Huang CC, Kodali BS. A Randomized Controlled Trial of Music Use During Epidural Catheter Placement on Laboring Parturient Anxiety, Pain, and Satisfaction. Anesth Analg. 2017 Feb;124(2):542-547. doi: 10.1213/ANE.0000000000001656.
PubMed 27984250
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Music Use in Parturients Admitted to Labor & Delivery
- ClinicalTrials.gov ID
- NCT06969105
- Acronym / sponsor ID
- STUDY00005897
- Conditions
- Anxiety, Pain, Patient Satisfaction
- Keywords
- music, labor and delivery, parturients, anxiety, analgesia, anesthesia, pain, epidural
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 May 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.
The goal of this clinical trial is to learn if music use affects anxiety or pain levels in parturients admitted to labor and delivery. It will also learn about the effect of music use on patient satisfaction. The main questions it aims to answer are:
Does music use affect anxiety levels in parturients admitted to labor and delivery? Does music use affect pain levels in parturients admitted to labor and delivery? Does music use affect patient satisfaction in parturients admitted to labor and delivery?
Researchers will compare music to a control (no music) to see if music affects anxiety levels in parturients admitted to labor and delivery.
Participants will:
Listen to music or listen to no music for a 10 minute duration in the labor and delivery unit.
Answer questions about anxiety and pain levels at a few different timepoints. Have information collected from medical charts (vital signs and cervical dilation).
Rate their satisfaction with care.
Detailed description
Subjects will be asked their preferred music choice before they are randomly assigned to either the intervention music group, or the no music control group.
The study's active intervention group will be listening to the subject's preferred music for a duration of 10 minutes. The subjects will listen to their preferred music choice played from a speaker connected to an audio device, both supplied by the research team. The investigator and the patient will collaborate on patient positioning of the audio device for sound to optimize comfort and safety during the study intervention. Researchers will confirm the volume of the music and assess subject's comfort before leaving the room for 10 minutes while they listen to music. Subjects must turn off all other noises such as television, other music being played, phone calls ringer/vibration, and texting notifications will be turned off prior to initiation of the study. Phone calls and texting may be left on for subject's who request this. The study team will wait outside the door for 10 minutes, before re-entering. Nursing and providers essential to care will be notified that the subject is participating in the study to ensure no one enters the room unless medically necessary or in case of emergency during this 10-minute time period.
The Control group will not listen to music. The study team will still leave the room for 10 minutes and then re-enter to continue collecting data at each of the time points as below:
Before the intervention begins, researchers will collect from all parturient subjects' their anxiety score (on a scale of 0-10, with 0 being no anxiety), ask them to complete the STAI questionnaires on paper to collect their scores (submitted) and pain score, and record the time data was collected. Researchers will also record clinical data from the EMR for the parturient subject or ask the nurses for the data at the time they take these readings (see Data Collection Form).
If parturient subjects request labor analgesia and have an epidural catheter placed, researchers will collect the same data from parturient subjects both at the time that the request is made and within 30 minutes of the catheter being placed. The data collected from these two timepoints is an optional component of the study (see Informed Consent Form). The subjects can consent ahead of time in the ICF but may withdraw consent for these 2 data points and still be in the rest of the study as the data collected at these 2 timepoints are secondary objectives to explore. If a member of the research team is not in the room at the time this happens, researchers will not collect Anxiety, STAI or pain score and will only collect what is available from the charts, as per the Data Collection Form.
After the intervention (or time has passed, if they are in the control group), the same information will be collected from all participants a second time (see Data Collection Form). Parturient satisfaction will be recorded (Data Collection Form). Nurses on the subject's normal care team will be asked to assist with collecting the vitals for the data collection forms.
All procedures are occurring for research purposes only. Initial vitals collected will be done as per standard care and data will only be pulled later from charts or researchers will ask the nurses for the information as they are collecting it. Later vitals collected, if done at a time where they are not being collected for standard care, will be collected for research only - by the standard care team nurses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will listen to music (intervention) and the other group will not listen to music (control).
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Other: MusicSubjects randomized to this arm will listen to music for a 10 minute duration. |
| Control Group | No intervention | –Subjects randomized to this arm will not listen to music for a 10 minute duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years or older
- Laboring parturients or those scheduled for an induction of labor
- Able to provide informed consent
- American Society of Anesthesiologists (ASA) physical status rating of II-III
Key exclusion criteria (5 listed)
- Patient refusal
- Impaired hearing
- Patient is taking at least one anxiolytic medication daily at baseline
- Intrauterine fetal demise
- Severe psychiatric disorder
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 |
|---|---|---|
| MusicPrior to randomization, all participants will pre-select their preferred music genre. If randomized to the music group, their preferred music genre will be played for a 10 minute duration. | Other | Music Group |
Primary outcome
Anxiety
Time frame: Baseline and 0 hours post-intervention
Anxiety will be assessed in two ways. The first using a 0-10 numeric rating scale in which subjects rate their self-perceived anxiety level on this scale. Secondly, they will answer survey questions on the State-Trait Anxiety Inventory questionnaire.
10 secondary outcomes
Pain Level
Time frame: Baseline to 0 hours post-intervention
Patient Satisfaction
Time frame: 0 hours post-intervention
Anxiety
Time frame: Request of labor analgesia and 0,1 hour post-epidural catheter placement
Pain Level
Time frame: Request of labor analgesia and 0,1 hours post-epidural catheter placement
Blood Pressure
Time frame: Request of labor analgesia and 0,1 hours post-epidural catheter placement
Heart Rate
Time frame: Request of labor analgesia and 0,1 hours post-epidural catheter placement
Oxygen Saturation
Time frame: Request of labor analgesia and 0,1 hours post-epidural catheter placement
Blood Pressure
Time frame: Baseline to 0 hours post-intervention
Oxygen Saturation
Time frame: Baseline to 0 hours post-intervention
Heart Rate
Time frame: Baseline to 0 hours post-intervention
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 1 May 2026.
- Background: PubMed 20642059Tabarro CS, de Campos LB, Galli NO, Novo NF, Pereira VM. [Effect of the music in labor and newborn]. Rev Esc Enferm USP. 2010 Jun;44(2):445-52. doi: 10.1590/s0080-62342010000200029. Portuguese.
- Background: PubMed 12836149Phumdoung S, Good M. Music reduces sensation and distress of labor pain. Pain Manag Nurs. 2003 Jun;4(2):54-61. doi: 10.1016/s1524-9042(02)54202-8.
- Background: PubMed 25227477Simavli S, Gumus I, Kaygusuz I, Yildirim M, Usluogullari B, Kafali H. Effect of music on labor pain relief, anxiety level and postpartum analgesic requirement: a randomized controlled clinical trial. Gynecol Obstet Invest. 2014;78(4):244-50. doi: 10.1159/000365085. Epub 2014 Sep 16.
- Background: PubMed 33050409Santivanez-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.
- Background: PubMed 20492051Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x.
- Background: PubMed 9710387Koch ME, Kain ZN, Ayoub C, Rosenbaum SH. The sedative and analgesic sparing effect of music. Anesthesiology. 1998 Aug;89(2):300-6. doi: 10.1097/00000542-199808000-00005.
- Background: PubMed 23894767Hosseini SE, Bagheri M, Honarparvaran N. Investigating the effect of music on labor pain and progress in the active stage of first labor. Eur Rev Med Pharmacol Sci. 2013 Jun;17(11):1479-87.
- Background: PubMed 40019185Fong TM, Drzymalski DM. The 95% Effective Duration of Music for Anxiolysis Before Elective Cesarean Delivery. A A Pract. 2025 Feb 28;19(3):e01931. doi: 10.1213/XAA.0000000000001931. eCollection 2025 Mar 1.
- Background: PubMed 27984250Drzymalski DM, Tsen LC, Palanisamy A, Zhou J, Huang CC, Kodali BS. A Randomized Controlled Trial of Music Use During Epidural Catheter Placement on Laboring Parturient Anxiety, Pain, and Satisfaction. Anesth Analg. 2017 Feb;124(2):542-547. doi: 10.1213/ANE.0000000000001656.
- Individual participant dataSharing planned: No
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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.
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 in people with Anxiety and Pain, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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 1 May 2026. 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 United States. 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 Sophia Struzziero, Medical Student (6178331209, sophia.struzziero@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Baseline and 0 hours post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06969105, which also lists 9 linked publications.
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 1 May 2026.