BirthNCT05693623
The Effect of Cold Application to the Sacral Area on Labor Comfort:
A study testing cold application in people with Birth, run by Emine Yıldırım.
Trial summary
Purpose: Cold application is considered as an effective alternative treatment for labor comfort because of its low side effects and easy availability. This study aims to determine the effect of cold application to the sacral area in the transition phase of labor on labor comfort. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth
- What is being tested?
- cold application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2023to 20 Mar 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria were having a full-term pregnancy (pregnancies between 37th and 42nd weeks),
- having a single fetus, having a cephalic presentation,
- fetal weight of 2,5- 4 kg,
- pregnant women's having normal body mass index and receiving no antenatal trainings,
- having an 8 cm cervical dilation.
Who cannot join
- The women who had any kind of pregnancy complications (placenta previa, preeclampsia,
- premature rupture of membranes, oligohydramnios and polyhydramnios, presentation disorder,
- intrauterine growth retardation, intrauterine dead fetus,
- macrosomia babies, fetal distress, etc.),
- who had any systemic or neurologic diseases
- contraction anomalies (hypotonic or hypertonic contractions),
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- who had induced labor,
- who received narcotic analgesics,
- who had occiput posterior,
- who were in the latent and active phases of labor,
- who had irregular contractions were excluded from the study
About this study
Official title: The Effect of Cold Application to the Sacral Area in the Transition Phase of Labor on Labor Comfort:
Purpose: Cold application is considered as an effective alternative treatment for labor comfort because of its low side effects and easy availability. This study aims to determine the effect of cold application to the sacral area in the transition phase of labor on labor comfort.
Materials and methods: The study was done as a randomised controlled experimental study. While the women in the experimental group received cold application for 10 minutes every 20 minutes after 8 cm of cervical dilatation, the women in control group received routine care protocol of the unit.
- Conditions
- Birth
- Being tested
- cold application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold applicationOther
cold application
| Study group | Role | What they receive |
|---|---|---|
| Cold Application to the Sacral Area | Experimental | Not described Receives: Other: cold application |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold Application to the Sacral Area on Labor Comfort
Cold Application to the Sacral Area on Labor Comfort
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start20 Feb 2023 (estimated)
- Primary completion20 Feb 2023 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BirthStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emine Yıldırım
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine Yıldırım, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693623
- Sponsor's protocol ID
- 12345
- Status last verified
- Jan 2023
- First submitted
- 18 Aug 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application to the Sacral Area in the Transition Phase of Labor on Labor Comfort:
- ClinicalTrials.gov ID
- NCT05693623
- Acronym / sponsor ID
- 12345
- Conditions
- Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emine YıldırımUniversity, hospital or other
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 23 Jan 2023 (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.
Purpose: Cold application is considered as an effective alternative treatment for labor comfort because of its low side effects and easy availability. This study aims to determine the effect of cold application to the sacral area in the transition phase of labor on labor comfort.
Materials and methods: The study was done as a randomised controlled experimental study. While the women in the experimental group received cold application for 10 minutes every 20 minutes after 8 cm of cervical dilatation, the women in control group received routine care protocol of the unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Application to the Sacral Area | Experimental | Other: cold application |
| control group | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The inclusion criteria were having a full-term pregnancy (pregnancies between 37th and 42nd weeks),
- having a single fetus, having a cephalic presentation,
- fetal weight of 2,5- 4 kg,
- pregnant women's having normal body mass index and receiving no antenatal trainings,
- having an 8 cm cervical dilation.
Key exclusion criteria (11 listed)
- The women who had any kind of pregnancy complications (placenta previa, preeclampsia,
- premature rupture of membranes, oligohydramnios and polyhydramnios, presentation disorder,
- intrauterine growth retardation, intrauterine dead fetus,
- macrosomia babies, fetal distress, etc.),
- who had any systemic or neurologic diseases
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 |
|---|---|---|
| cold applicationcold application | Other | Cold Application to the Sacral Area |
Primary outcome
Cold Application to the Sacral Area on Labor Comfort
Time frame: through study completion, an average of 1 year
Cold Application to the Sacral Area on Labor Comfort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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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 cold application in people with Birth, run by Emine Yıldırım.
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 5 inclusion and 11 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 23 Jan 2023. 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?
Cold Application to the Sacral Area on Labor Comfort (time frame: through study completion, an average of 1 year). 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 23 Jan 2023.