The Effect of Music Therapy on Labour Pain, Anxiety, and Analgesia

NCT05149677 | Unknown DMC

• 1 other identifier: CREC MN178 20/21
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain; anxiety; labour; primiparous; music; therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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.

  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.

  Duration in hours from admission until delivery

Study Arms (2)

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

Behavioral: Music therapy

Interventions

Music therapy BEHAVIORAL

Music therapy intervention + Standard of Care for labor pain

Music therapy intervention + Standard of Care for labor pain

Eligibility Criteria

• Age: 18 Months - 65 Months
• Gender Eligibility Details: women 37 and 41 weeks of gestation in labour
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University of the West Indies Mona Jamaica

Kingston, 0000, Jamaica

RECRUITING

MeSH Terms

Conditions

Labor Pain; Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carole Rattray

  University Hospital of the West Indies Mona Jamaica- Maternity Delivery Unit

  PRINCIPAL INVESTIGATOR

• M Campbell-Mitchell

  University Hospital of the West Indies Mona Jamaica- Maternity Delivery Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 8, 2021
• Study Start: January 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-10

Locations

JA (1)