Labor and DeliveryNCT07566962
Effect of Mechanical Massage Cushion on Labor Pain and Comfort
A study testing massage in people with Labor and Delivery and Labor Comfort, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor and Delivery, Labor Comfort, Labor Pain
- What is being tested?
- massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mechanical Massage Cushion on Labor Pain and Comfort: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Labor and Delivery, Labor Comfort, Labor Pain, Pregnant Women, Massage
- Being tested
- massage
- Keywords
- Labor, labor pain, labor comfort, pregnant, massage
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Nov 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor and DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Guluzar Sade, Tarsus University
- Investigators
- Hava Özkan, PhD, Study director, Prof. Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566962
- Sponsor's protocol ID
- Tarsus University
- Other IDs
- Project number 10119
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We obtained permission from the participants by stating that we would only use their data in this study; I do not find it ethical to use or share it in another study.
Publications
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.
PubMed 26744335Jones 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.
PubMed 22419342
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Massage Cushion on Labor Pain and Comfort: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07566962
- Acronym / sponsor ID
- Tarsus University
- Conditions
- Labor and Delivery, Labor Comfort, Labor Pain, Pregnant Women, Massage
- Keywords
- Labor, labor pain, labor comfort, pregnant, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage | Experimental | Other: massageDuring 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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massageThe 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. | Other | massage |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 26744335Poppendieck 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.
- Background: PubMed 22419342Jones 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.
- Individual participant dataSharing planned: No. We obtained permission from the participants by stating that we would only use their data in this study; I do not find it ethical to use or share it in another study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hava Özkan, PhD study director
Prof. Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage in people with Labor and Delivery and Labor Comfort, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of childbirth comfort (time frame: The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07566962, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.