Effect of Mechanical Massage Cushion on Labor Pain and Comfort

NCT07566962 | Completed

• 2 other identifiers: Tarsus UniversityProject number 10119
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to examine the effect of mechanical massage applied with a mechanical massage cushion during labor on labor pain and comfort. This research is a randomized controlled experimental study. The universe of the study consisted of primiparous women who gave birth normally in a state hospital between November 2021 and February 2022, and the sample consisted of 70 pregnant women (35 pregnant women in the experimental group and 35 pregnant women in the control group) who met the selection criteria. Data were collected face-to-face with the Personal Information Form, Visual Analog Scale (VAS), Verbal Category Scale (VCS), and Childbirth Comfort Questionnaire (CCQ). Data were analyzed using the SPSS 22.0 package program.

Conditions

Labor and Delivery; Labor Comfort; Labor Pain; Pregnant Women; Massage

Keywords

Labor; labor pain; labor comfort; pregnant; massage

Outcome Measures

Primary Outcomes (3)

• Assessment of childbirth comfort

  Childbirth Comfort Questionnaire (CCQ): The scale was developed by Schuiling in 2003. The Turkish validity and reliability of the scale were examined by Coskuner et al. in 2015. The scale is a 5-point Likert-type instrument, consisting of 9 items and 3 sub-dimensions. The minimum score is 9 and the maximum score is 45. A high score indicates high comfort.

  The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.

• Assessment of labor pain

  Visual Analog Scale (VAS): It is a scale where painlessness and unbearable pain are indicated on a 10 cm ruler, and the individual marks the pain they perceive. When evaluating the scale, the distance between the beginning and the marked part is measured with the ruler and the distances are determined as 0-2 cm; 3-4 cm; 5-6 cm; 7-8 cm and 9-10 cm and should be interpreted as no pain; mild pain, moderate pain; severe pain and unbearable pain, respectively.

  VAS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).

• Assessment of labor pain

  Verbal Category Scale (VCS): It is a one-dimensional scale that defines the severity of pain. Pain is divided into categories from mild to unbearable. The individual marks the part of the scale that corresponds to their pain.

  VCS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).

Study Arms (2)

massage

EXPERIMENTAL

During the active phase, the pregnant woman was asked to manage the mechanical massage cushion and massage the desired areas at the desired intensity until the end of the phase. Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm). The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.

Other: massage

control

NO INTERVENTION

Standard care was applied to the control group. Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm). The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.

Interventions

massage OTHER

The mechanical massage cushion was introduced to the pregnant woman and its use was explained. In addition to routine hospital procedures, during the latent phase, a custom-made bed protector and towel were placed on the mechanical massage cushion, and the researcher accompanied the pregnant woman during the first massage application. The bed protector and towel were changed as needed when soiled. During the active phase, the pregnant woman was asked to manage the mechanical massage cushion and massage the desired areas at the desired intensity until the end of the phase. Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm). The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.

massage

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least a primary school graduate, no communication problems, healthy at term pregnancies, primiparous pregnants, in the latent phase of labor (cervical dilation 0-3 cm).

You may not qualify if:

• Foreign pregnant women, multiparous pregnants, pregnant women who dropped out of the study, pregnant women who experienced complications and required a cesarean section, pregnant women who were admitted to the delivery room while using an automatic massage cushion on another pregnant woman.

Sponsors & Collaborators

• Tarsus University: lead
• Ataturk University: collaborator

Study Sites (1)

Tarsus University

Mersin, Turkey (Türkiye)

Location

Related Publications (2)

• Poppendieck W, Wegmann M, Ferrauti A, Kellmann M, Pfeiffer M, Meyer T. Massage and Performance Recovery: A Meta-Analytical Review. Sports Med. 2016 Feb;46(2):183-204. doi: 10.1007/s40279-015-0420-x.

  PMID: 26744335 BACKGROUND

• Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.

  PMID: 22419342 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Hava Özkan, PhD

  Prof. Dr.

  STUDY DIRECTOR

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: Asst. Prof. Dr.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: May 5, 2026
• Study Start: November 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)