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NCT Number: NCT07566962

Effect of Mechanical Massage Cushion on Labor Pain and Comfort

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.

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Key information

Conditions

Labor and Delivery Labor Comfort Labor Pain Massage Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pregnant Women Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus University

Mersin, Turkey (Türkiye)

About this study

Massage applied during birth provides relaxation to the pregnant woman, reduces pain, anxiety, agitation, and depressive mood, relaxes muscle spasms, and reduces the duration of birth and hospital stay. There are a limited number of studies in the literature on mechanical massage during birth. 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. The normal distribution of the data was evaluated using the number, percentage, mean, chi-square, and t-test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Assessment of childbirth comfort

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

    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.

  2. Assessment of labor pain

    Time frame: 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).

    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.

  3. Assessment of labor pain

    Time frame: 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).

    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.

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Collaborators

  • Ataturk University

Registry information

Official study title

Effect of Mechanical Massage Cushion on Labor Pain and Comfort: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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