NCT05317052

Brief Summary

Birth pain is the most severe painful experience faced by primiparous people. Massage and music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

March 30, 2022

Last Update Submit

February 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) Score

    The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort

    In the labour (active and transition phase)

Secondary Outcomes (2)

  • Postpartum Comfort Scale

    At the enf of the delivery (In the 24 th hours)

  • Posttraumatic Growth Inventory

    At the enf of the delivery (In the 24 th hours)

Study Arms (3)

Massage

EXPERIMENTAL

Massage therapy

Behavioral: Massage group

Music

EXPERIMENTAL

Music therapy

Behavioral: Massage group

Control

NO INTERVENTION

Control

Interventions

Massage groupBEHAVIORAL

Massage and music therapy

Also known as: Music group
MassageMusic

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimiparous pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Expectation of normal vaginal delivery
  • Having a term pregnancy
  • Being primiparous - Being in the active phase of labor (Cervical dilatation 4 cm)
  • Single pregnancy
  • Being in vertex presentation
  • Uncomplicated prenatal process
  • Volunteering to participate in the study
  • Being pregnant without back pain

You may not qualify if:

  • Pregnant women whose birth resulted in cesarean section due to failure of labor to progress during labor
  • Pregnant women who did not undergo induction
  • Pregnant women who underwent pharmacological intervention for labor pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Researcher of the Amasya University Midwifery Department

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 7, 2022

Study Start

April 15, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations