Labor PainNCT05149677
The Effect of Music Therapy on Labour Pain, Anxiety, and Analgesia
A study testing Music therapy in people with Labor Pain, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
Labour pain is the result of complex and subjective interactions of multiple physiologic and psychosocial factors on a woman's interpretation of labour stimuli. It is an integral part of the labour process, often associated with anxiety and being subjective, affects each woman's experience of the birthing process in… Read more about this study
- Who is it for?
- Ages 18 to 65 months, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteJamaica
- Study dates
- Jan 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 months
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Women attending the UHWI antenatal clinic (General antenatal clinic or departmental antenatal clinic)
- Primiparous
- Age 18 years and over
- ≥ 37weeks pregnancy
- Singleton Foetus
- Consent to participate in study
Who cannot join
- Multiparous
- Preterm pregnancy
- Multiple Gestation
- Planned Caesarean Section
- Epidural Analgesia or treatment antipsychotic medication
- Comorbid illness: maternal hypertensive disorders, diabetes mellitus, evidence of intrauterine growth restriction, suspected macrosomia, premature rupture of membranes, maternal hearing difficulties, chronic pain problems, severe dysmenorrhea, foetal death in utero, known cardiovascular or another foetal anomaly
- inability to understand the visual analogue scale
- No consent to participate in study
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
University of the West Indies Mona Jamaica
Kingston, 0000
Minerva Thame, 876 927-1297 ext. 52-2478-9, minerva.thame@uwimona.edu.jm
Dr Carole Rattray, kay.rattray@gmail.com
About this study
Official title: The Effect of Music Therapy on Labour Pain, Anxiety, and Analgesia Requirement in Primiparous Patients A Randomized Controlled Clinical Trial
Labour pain is the result of complex and subjective interactions of multiple physiologic and psychosocial factors on a woman's interpretation of labour stimuli. It is an integral part of the labour process, often associated with anxiety and being subjective, affects each woman's experience of the birthing process in differing ways.
This will be a randomized clinical trial, involving primiparous women presenting to the University Hospital of the West Indies (UHWI) for labour and delivery. Primiparous, term women in labour will be eligible and randomized in a 1:1 ratio to receive music plus standard of care during labour and standard care without music therapy.
The primary outcome of this study will be to determine whether music therapy is an effective adjunct or alternative to pharmacological therapies for pain and anxiety management in labour. The secondary outcome would be to assess the effect of music on labour duration, operative delivery rates, abnormal foetal heart rate patterns and APGAR scores. Approximately 260 primigravida women would be recruited and invited to participate in this randomized clinical trial over an eight-month period.
Read the detailed description
The Cambridge dictionary describes pain as a feeling of physical suffering caused by injury and illnesses. This physical suffering is a subjective, natural, and inevitable process associated with labour that is understandably, a most feared aspect of pregnancy for expectant mothers. A woman's birthing experience is influenced by her social environment and how she contextualizes the idea of pain as purposeful and productive versus threatening, the latter of which could result in a more negative pain response. Historically prior to the 18th century, natural methods were the only options for pain relief for women in labour. These included various breathing techniques and positioning, massage techniques and herbal mixtures. There is an increasing movement back to the historical practices of traditional and non- pharmacological pain relief during labour, and research in these techniques is needed to prove clinical effectiveness. According to the World Health Organisation (WHO) recommendations: intrapartum care for a positive childbirth experience- " Most women desire some form of pain relief during labour, and qualitative evidence indicates that relaxation techniques can reduce labour discomfort, relieve pain and enhance the maternal birth experience."
One of the most used pharmacological agents during labour is meperidine hydrochloride (Pethidine®) as it is readily available with a higher level of administrator comfort than other agents. Overuse of pharmacological interventions can lead to increased maternal and neonatal morbidity, reduced local supply of pharmacological agents and even financial strain on low resource institutions. Patients with a low pain threshold in early labour due to anxiety and fear may also request analgesia in the latent phase which can result in the inability to receive repeated doses early in the active phase due to dosing frequency guidelines. This can then result in maternal distress and poor labour outcomes when the additive effect of labour progression, results in more severe pain. Meperidine hydrochloride has been shown to offer variable pain control with a more sedation than analgesic effect, hence adjunctive therapy with music may prove beneficial for its potential additive analgesic effect. Meperidine hydrochloride's use has also been found to be associated with increased rate of augmentation in labour, increased operative deliveries, and adverse maternal effects such as nausea, vomiting and dizziness and also a linkage to neonatal respiratory depression \& APGAR scores < 7 and acidosis [umbilical artery potential of Hydrogen (pH) <7.12] have been noted.
The United Nation (UN) Global Strategy for Women's, Children's and Adolescents' Health seeks to ensure that not only do women survive childbirth complications if they arise, but also that they thrive and reach their full potential for health and life. To facilitate safe labour and childbirth, attention must be given to the management of the psychological and emotional needs of women. Anxiety of the labour process is frequently seen in mothers presenting for delivery. This is shown to be more common in primiparous women especially if they have not received antenatal counselling on what to expect in labour(9). Studies have shown that anxiety can stimulate the sympathetic nervous system, releasing excessive stress hormones such as cortisol and adrenaline contributing to dysfunctional uterine contractility and labour dystocia. Music therapy has been shown to be an effective, inexpensive, safe and non-invasive intervention for patients undergoing many non-obstetric procedures such as decreased pain and anxiety during bone marrow biopsy and aspiration and nasal bone fracture reduction as well as decreased anxiety and propofol (Diprivan®) consumption during colonoscopy/endoscopy.
With more women exploring the option of physiological birthing techniques ("Natural Birthing Techniques"), an approach to labour and birth that normalizes the strength and physiology of the woman and foetus and refrains from external intervention unless there is potential compromise to mother or foetus, music therapy may offer a natural alternative to pharmacological approaches to pain relief that are the standard of care in may labour and delivery suites.
Music can have a direct impact on the perception of pain by activating the gate-control theory of pain which attacks both cognitive and physiological factors associated with pain. The gate theory works on the idea that there is a gateway in the dorsal horn of the spinal cord that manages the perception of pain via opening and closing of this gate. Pain sensation is carried via small neural fibres that pass this gate in route to the brain for interpretation. Music can close this gateway by stimulating a large number of neurological fibres some of which would have been activated for a pain response if available, and hence no transmission of pain sensation in response to stimulation. Music can also serve as a distraction mechanism improving general mood and hence decreasing negative pain perception.
Music during labour is perceived by the right hemisphere of the brain and can result in the release of endorphins which provide analgesia by binding to opioid receptors at pre and post synaptic nerve terminals. This binding results in the inhibition of substance P an important protein involved in the transmission of pain. Studies show that decreased levels of serum cortisol and the release of neural system of reward hormones such as dopamine is linked to the anxiety reducing effect of music therapy.
In a study performed by Buglione et al., pain level during active phase of labour was 8.8 ± 0.9 in music group and, 9.8 ± 0.3 in control group [Mean Difference (MD) - 1.00 point, 95%, Chloride (Cl) - 1.48 to - 0.52; P <0.01]. Music during labour and delivery was also associated with decreased pain 1h postpartum as well as decreased anxiety levels during the active phase, second stage and 1hour postpartum. This study was however studied in a small population of 30 Italian women; hence generalizability of findings is uncertain. A meta-analysis and systematic review of studies published between 2003 and June 2018 showed significant differences in Visual Analog pain scale (VAS) scores in favour of music therapy in the intensity of latent phase of labour pain (MD: -0.73; 95% Cl -0.99, -0.48); in the active phase (MD: -0.68; 95% Cl -0.92, -0.44) in its entirety or during the first phase (MD: -1.71; 95% Cl -2.65, -0.77) and second hour postintervention (MD: -2.90; 95% Cl -3.79, -2.01). In terms of anxiety, Santiváñez-Acosta et al evaluated three studies which revealed significant differences in anxiety level in the latent phase (MD: -0.74; 95% Cl -1.00, -0.48) and active phase of labour (MD: -0.76; 95% Cl -0.88, -0.64).
- Conditions
- Labor Pain
- Being tested
- Music therapy
- Keywords
- pain, anxiety, labour, primiparous, music, therapy
- Medical subject headings
- Labor Pain, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Music therapy intervention + Standard of Care for labor pain
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care for labor pain | No intervention | Standard of Care of Care for labor pain |
| Music therapy intervention + Standard of Care for labor pain | Experimental | Music therapy intervention + Standard of Care for labor pain Receives: Behavioral: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in mean pain visual pain score between standard of care group during latent phase of labor and Music therapy intervention group
Pain will be assessed during each 30-minute intervals following consecutive hourly observations using a self-reported visual analogue scale with range of scores from 0 to 10 with 0 indicating no pain and 10 indicating maximum pain during the latent phase of labour (cervical dilation 2-4 cm). The mean pain scores during phase will be computed for each group (music therapy group with standard of care and the standard of care group ) and their mean difference compared.
Measured: Duration in hours from admission until the end of latent phase of labour
difference in mean pain visual pain score between standard of care group during active phase of labor and Music therapy intervention group
Pain will be assessed during each 30-minute intervals following consecutive hourly observations for 3 hours using a self-reported visual analogue scale with range of scores from 0 to 10 with 0 indicating no pain and 10 indicating maximum pain during the latent phase of labour (cervical dilation >=5 cm). The mean pain scores during active phase will be computed for each group (music therapy group with standard of care and the standard of care group ) and their mean difference compared.
Measured: Duration in hours from start of active phase for up to 3 hours.
difference in pain visual pain score between standard of care group 2 hours post delivery of labor and Music therapy intervention group
Pain will be assessed at 2 hours post delivery using a self-reported visual analogue scale with range of scores from 0 to 10 with 0 indicating no pain and 10 indicating maximum pain. The pain scores at 2 hours post-delivery will be assessed for each group (music therapy group with standard of care and the standard of care group ) and their mean difference compared.
Measured: At 2 hours post delivery
difference in duration of labour between standard of care group during active phase of labor and Music therapy intervention group
The duration of latent and active phase of labour will be measured in minutes for each participant in each group (music therapy group with standard of care and the standard of care group ) and their mean computed. The difference in mean duration of labor by groups will be compared.
Measured: Duration in hours from admission until delivery
Secondary outcomes (2)
Difference in mean APGAR score at 5 minutes post -delivery of children of mothers assigned to standard of care group and Music therapy intervention group.
The APGAR score at 5 minutes for each infant born to mothers assigned to (music therapy group with standard of care and the standard of care group ) will be assessed and the group means computed. The difference in mean APGAR score by groups will be compared.
Measured: At 5 minutes post delivery
Difference in mean cumulative amounts of analgesia used during labor and delivery for mothers assigned to standard of care group and Music therapy intervention group.
The amounts of analgesia used for each woman during labour and delivery will be recorded.The amounts of analgesia used will be converted to equianalgesic doses. The difference in mean cumulative equianalgesic amounts by groups will be compared.
Measured: Duration in hours from admission until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole Rattray, Principal investigator, University Hospital of the West Indies Mona Jamaica- Maternity Delivery UnitM Campbell-Mitchell, Principal investigator, University Hospital of the West Indies Mona Jamaica- Maternity Delivery Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149677
- Sponsor's protocol ID
- CREC MN178 20/21
- Status last verified
- Oct 2021
- First submitted
- 8 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Labour Pain, Anxiety, and Analgesia Requirement in Primiparous Patients A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05149677
- Acronym / sponsor ID
- CREC MN178 20/21
- Conditions
- Labor Pain
- Keywords
- pain, anxiety, labour, primiparous, music, therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 8 Dec 2021 (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.
Labour pain is the result of complex and subjective interactions of multiple physiologic and psychosocial factors on a woman's interpretation of labour stimuli. It is an integral part of the labour process, often associated with anxiety and being subjective, affects each woman's experience of the birthing process in differing ways.
This will be a randomized clinical trial, involving primiparous women presenting to the University Hospital of the West Indies (UHWI) for labour and delivery. Primiparous, term women in labour will be eligible and randomized in a 1:1 ratio to receive music plus standard of care during labour and standard care without music therapy.
The primary outcome of this study will be to determine whether music therapy is an effective adjunct or alternative to pharmacological therapies for pain and anxiety management in labour. The secondary outcome would be to assess the effect of music on labour duration, operative delivery rates, abnormal foetal heart rate patterns and APGAR scores. Approximately 260 primigravida women would be recruited and invited to participate in this randomized clinical trial over an eight-month period.
Detailed description
The Cambridge dictionary describes pain as a feeling of physical suffering caused by injury and illnesses. This physical suffering is a subjective, natural, and inevitable process associated with labour that is understandably, a most feared aspect of pregnancy for expectant mothers. A woman's birthing experience is influenced by her social environment and how she contextualizes the idea of pain as purposeful and productive versus threatening, the latter of which could result in a more negative pain response. Historically prior to the 18th century, natural methods were the only options for pain relief for women in labour. These included various breathing techniques and positioning, massage techniques and herbal mixtures. There is an increasing movement back to the historical practices of traditional and non- pharmacological pain relief during labour, and research in these techniques is needed to prove clinical effectiveness. According to the World Health Organisation (WHO) recommendations: intrapartum care for a positive childbirth experience- " Most women desire some form of pain relief during labour, and qualitative evidence indicates that relaxation techniques can reduce labour discomfort, relieve pain and enhance the maternal birth experience."
One of the most used pharmacological agents during labour is meperidine hydrochloride (Pethidine®) as it is readily available with a higher level of administrator comfort than other agents. Overuse of pharmacological interventions can lead to increased maternal and neonatal morbidity, reduced local supply of pharmacological agents and even financial strain on low resource institutions. Patients with a low pain threshold in early labour due to anxiety and fear may also request analgesia in the latent phase which can result in the inability to receive repeated doses early in the active phase due to dosing frequency guidelines. This can then result in maternal distress and poor labour outcomes when the additive effect of labour progression, results in more severe pain. Meperidine hydrochloride has been shown to offer variable pain control with a more sedation than analgesic effect, hence adjunctive therapy with music may prove beneficial for its potential additive analgesic effect. Meperidine hydrochloride's use has also been found to be associated with increased rate of augmentation in labour, increased operative deliveries, and adverse maternal effects such as nausea, vomiting and dizziness and also a linkage to neonatal respiratory depression \& APGAR scores < 7 and acidosis [umbilical artery potential of Hydrogen (pH) <7.12] have been noted.
The United Nation (UN) Global Strategy for Women's, Children's and Adolescents' Health seeks to ensure that not only do women survive childbirth complications if they arise, but also that they thrive and reach their full potential for health and life. To facilitate safe labour and childbirth, attention must be given to the management of the psychological and emotional needs of women. Anxiety of the labour process is frequently seen in mothers presenting for delivery. This is shown to be more common in primiparous women especially if they have not received antenatal counselling on what to expect in labour(9). Studies have shown that anxiety can stimulate the sympathetic nervous system, releasing excessive stress hormones such as cortisol and adrenaline contributing to dysfunctional uterine contractility and labour dystocia. Music therapy has been shown to be an effective, inexpensive, safe and non-invasive intervention for patients undergoing many non-obstetric procedures such as decreased pain and anxiety during bone marrow biopsy and aspiration and nasal bone fracture reduction as well as decreased anxiety and propofol (Diprivan®) consumption during colonoscopy/endoscopy.
With more women exploring the option of physiological birthing techniques ("Natural Birthing Techniques"), an approach to labour and birth that normalizes the strength and physiology of the woman and foetus and refrains from external intervention unless there is potential compromise to mother or foetus, music therapy may offer a natural alternative to pharmacological approaches to pain relief that are the standard of care in may labour and delivery suites.
Music can have a direct impact on the perception of pain by activating the gate-control theory of pain which attacks both cognitive and physiological factors associated with pain. The gate theory works on the idea that there is a gateway in the dorsal horn of the spinal cord that manages the perception of pain via opening and closing of this gate. Pain sensation is carried via small neural fibres that pass this gate in route to the brain for interpretation. Music can close this gateway by stimulating a large number of neurological fibres some of which would have been activated for a pain response if available, and hence no transmission of pain sensation in response to stimulation. Music can also serve as a distraction mechanism improving general mood and hence decreasing negative pain perception.
Music during labour is perceived by the right hemisphere of the brain and can result in the release of endorphins which provide analgesia by binding to opioid receptors at pre and post synaptic nerve terminals. This binding results in the inhibition of substance P an important protein involved in the transmission of pain. Studies show that decreased levels of serum cortisol and the release of neural system of reward hormones such as dopamine is linked to the anxiety reducing effect of music therapy.
In a study performed by Buglione et al., pain level during active phase of labour was 8.8 ± 0.9 in music group and, 9.8 ± 0.3 in control group [Mean Difference (MD) - 1.00 point, 95%, Chloride (Cl) - 1.48 to - 0.52; P <0.01]. Music during labour and delivery was also associated with decreased pain 1h postpartum as well as decreased anxiety levels during the active phase, second stage and 1hour postpartum. This study was however studied in a small population of 30 Italian women; hence generalizability of findings is uncertain. A meta-analysis and systematic review of studies published between 2003 and June 2018 showed significant differences in Visual Analog pain scale (VAS) scores in favour of music therapy in the intensity of latent phase of labour pain (MD: -0.73; 95% Cl -0.99, -0.48); in the active phase (MD: -0.68; 95% Cl -0.92, -0.44) in its entirety or during the first phase (MD: -1.71; 95% Cl -2.65, -0.77) and second hour postintervention (MD: -2.90; 95% Cl -3.79, -2.01). In terms of anxiety, Santiváñez-Acosta et al evaluated three studies which revealed significant differences in anxiety level in the latent phase (MD: -0.74; 95% Cl -1.00, -0.48) and active phase of labour (MD: -0.76; 95% Cl -0.88, -0.64).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care for labor pain | No intervention | –Standard of Care of Care for labor pain |
| Music therapy intervention + Standard of Care for labor pain | Experimental | Behavioral: Music therapyMusic therapy intervention + Standard of Care for labor pain |
Who may qualify
- Ages
- 18 to 65 months
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Women attending the UHWI antenatal clinic (General antenatal clinic or departmental antenatal clinic)
- Primiparous
- Age 18 years and over
- ≥ 37weeks pregnancy
- Singleton Foetus
Key exclusion criteria (8 listed)
- Multiparous
- Preterm pregnancy
- Multiple Gestation
- Planned Caesarean Section
- Epidural Analgesia or treatment antipsychotic medication
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 therapyMusic therapy intervention + Standard of Care for labor pain | Behavioural | Music therapy intervention + Standard of Care for labor pain |
Primary outcome
difference in mean pain visual pain score between standard of care group during latent phase of labor and Music therapy intervention group
Time frame: Duration in hours from admission until the end of latent phase of labour
Pain will be assessed during each 30-minute intervals following consecutive hourly observations using a self-reported visual analogue scale with range of scores from 0 to 10 with 0 indicating no pain and 10 indicating maximum pain during the latent phase of labour (cervical dilation 2-4 cm). The mean pain scores during phase will be computed for each group (music therapy group with standard of care and the standard of care group ) and their mean difference compared.
difference in mean pain visual pain score between standard of care group during active phase of labor and Music therapy intervention group
Time frame: Duration in hours from start of active phase for up to 3 hours.
Pain will be assessed during each 30-minute intervals following consecutive hourly observations for 3 hours using a self-reported visual analogue scale with range of scores from 0 to 10 with 0 indicating no pain and 10 indicating maximum pain during the latent phase of labour (cervical dilation >=5 cm). The mean pain scores during active phase will be computed for each group (music therapy group with standard of care and the standard of care group ) and their mean difference compared.
difference in pain visual pain score between standard of care group 2 hours post delivery of labor and Music therapy intervention group
Time frame: At 2 hours post delivery
Pain will be assessed at 2 hours post delivery using a self-reported visual analogue scale with range of scores from 0 to 10 with 0 indicating no pain and 10 indicating maximum pain. The pain scores at 2 hours post-delivery will be assessed for each group (music therapy group with standard of care and the standard of care group ) and their mean difference compared.
difference in duration of labour between standard of care group during active phase of labor and Music therapy intervention group
Time frame: Duration in hours from admission until delivery
The duration of latent and active phase of labour will be measured in minutes for each participant in each group (music therapy group with standard of care and the standard of care group ) and their mean computed. The difference in mean duration of labor by groups will be compared.
2 secondary outcomes
Difference in mean APGAR score at 5 minutes post -delivery of children of mothers assigned to standard of care group and Music therapy intervention group.
Time frame: At 5 minutes post delivery
Difference in mean cumulative amounts of analgesia used during labor and delivery for mothers assigned to standard of care group and Music therapy intervention group.
Time frame: Duration in hours from admission until delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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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. This study is not recruiting at the moment.
University of the West Indies Mona Jamaica
Kingston, Jamaica
Carole Rattray principal investigator
University Hospital of the West Indies Mona Jamaica- Maternity Delivery Unit
M Campbell-Mitchell principal investigator
University Hospital of the West Indies Mona Jamaica- Maternity Delivery Unit
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 therapy in people with Labor Pain, run by The University of The West Indies at 1 site in Jamaica.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Dec 2021. 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 Jamaica. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in mean pain visual pain score between standard of care group during latent phase of labor and Music therapy intervention group (time frame: Duration in hours from admission until the end of latent phase of labour). The study lists 4 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 8 Dec 2021.