Labor PainNCT06499402
The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction
A study testing massage in people with Labor Pain and Labor, run by Osmaniye Korkut Ata University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 days, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Labor
- What is being tested?
- massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2024to 22 Sep 2024
- 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 45 days
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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".
- Conditions
- Labor Pain, Labor
- Being tested
- 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
sacral massage
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| experimental group | Experimental | Not described Receives: Other: massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress
questionnaire, stress scale
Measured: 1 day
Secondary outcomes (1)
labor pain
pain scale, VAS
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start22 Jul 2024 (estimated)
- Primary completion22 Aug 2024 (estimated)
- Study completion22 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Yıldırım, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499402
- Sponsor's protocol ID
- 12345678
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction
- ClinicalTrials.gov ID
- NCT06499402
- Acronym / sponsor ID
- 12345678
- Conditions
- Labor Pain, Labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 22 Jul 2024 (estimated)
- Primary completion
- 22 Aug 2024 (estimated)
- Study completion
- 22 Sep 2024 (estimated)
- First posted
- 12 Jul 2024 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| experimental group | Experimental | Other: massage |
Who may qualify
- Ages
- 18 to 45 days
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| massagesacral massage | Other | experimental group |
Primary outcome
stress
Time frame: 1 day
questionnaire, stress scale
1 secondary outcome
labor pain
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing massage in people with Labor Pain and Labor, run by Osmaniye Korkut Ata University.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
stress (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2024.