The Effect of Music Therapy on Labour Pain, Anxiety, and Analgesia
NCT05149677 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2021-12-08
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 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.
Conditions
- Labor Pain
Interventions
- BEHAVIORAL
-
Music therapy
Music therapy intervention + Standard of Care for labor pain
Sponsors & Collaborators
-
The University of The West Indies
lead OTHER
Principal Investigators
-
Carole Rattray · University Hospital of the West Indies Mona Jamaica- Maternity Delivery Unit
-
M Campbell-Mitchell · University Hospital of the West Indies Mona Jamaica- Maternity Delivery Unit
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Months
- Max Age
- 65 Months
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-01-31
- Primary Completion
- 2022-09-30
- Completion
- 2022-10-31
Countries
- Jamaica
Study Locations
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