NCT06499402

Brief Summary

Our study aims to determine the effect of pregnant-controlled automatic sacral massage on mothers' labor pain, perception, process and midwives' satisfaction. The research was planned as a randomized controlled experimental study. A total of 112 women, 56 pregnant women in the experimental and control groups, will be included in the study. In this project, an automatic massage device will be used during the active phase (when the cervical opening is between 5-6 cm and 10 cm) and a massage device in line with the pregnancy-controlled sacral massage application protocol. Pregnant women are followed throughout the active phase of labor and indicators reflecting labor pain, progress of labor, and the health status of the mother and the baby are used with the "Individual Identification Form", "Visual Comparison Scale", "Labor Monitoring Form", "Mother's Birth Perception Scale (ADAS)". The satisfaction of midwives will be evaluated with the "Evaluation of Satisfaction Status of Midwives Form".

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

July 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 4, 2024

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • stress

    questionnaire, stress scale

    1 day

Secondary Outcomes (1)

  • labor pain

    1 day

Study Arms (2)

control group

NO INTERVENTION

experimental group

EXPERIMENTAL
Other: massage

Interventions

massageOTHER

sacral massage

experimental group

Eligibility Criteria

Age18 Days - 45 Days
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participating in the study voluntarily
  • having a cervical dilatation of 5-6 cm,
  • being between 38-40 weeks of pregnancy,- being a single fetus, having a cephalic presentation,
  • having a fetal weight between 2.5-4 kg,
  • having no vision-hearing problems,
  • having communication and cooperation skills

You may not qualify if:

  • having pregnancy complications
  • Those who have acute inflammatory problems in soft tissues, skin or joints, burns, nerve injuries, open wounds, rheumatoid and gouty arthritis,
  • those who have used any non-pharmacological methods will not be admitted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Labor Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 4, 2024

First Posted

July 12, 2024

Study Start

July 22, 2024

Primary Completion

August 22, 2024

Study Completion

September 22, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07