The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction

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".

Study Overview

• Status: Not yet recruiting
• Conditions: Labor Pain; Labor
• Intervention / Treatment: Other: massage

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group	Other: massage; sacral massage
No Intervention: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stress	questionnaire, stress scale	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
labor pain	pain scale, VAS	1 day

Collaborators and Investigators

• Sponsor: Osmaniye Korkut Ata University

Study record dates

Study Major Dates

• Study Start (Estimated): July 22, 2024
• Primary Completion (Estimated): August 22, 2024
• Study Completion (Estimated): September 22, 2024

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 12345678

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No