Labor PainNCT03066973
BREATHING EXERCISES FOR LABOR PAIN AND DURATION
A study testing BREATHING EXERCISE in people with Labor Pain and Breathing Exercise, run by Ataturk University.
Trial summary
This study aimed to assess the efficacy of breathing exercises (BE) during the second stage of labor for maternal pain, duration of labor and first-minute APGAR score. This is a randomized controlled trial that compares nulliparous pregnant in the second stage of labor instructed regarding BE with a control group (CG)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Breathing Exercise
- What is being tested?
- BREATHING EXERCISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 30 Jul 2016
- 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 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nullipar females
- Gestational age 37-42 week
Who cannot join
- Analgesic and anestezice use
- Clinical instability
- Psychiatric disorders
About this study
Official title: THE EFFECTIVENESS OF BREATHING EXERCISES TO LABOR PAIN and DURATION: A RANDOMIZED CONTROLLED TRIAL
This study aimed to assess the efficacy of breathing exercises (BE) during the second stage of labor for maternal pain, duration of labor and first-minute APGAR score. This is a randomized controlled trial that compares nulliparous pregnant in the second stage of labor instructed regarding BE with a control group (CG) that received standard care service. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum. One session of BE training were given to pregnant in intervention group (IG). Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of birth. Time of the second stage was recorded as second (sec), and first minute APGAR scores were recorded. Significance was set at p<0.05.
Read the detailed description
In this trial, it is aimed to assess the effectiveness of breathing exercises (BE) for management of labor pain during the second stage of labor. Nulliparous pregnant were randomized two arms. Intervention group received breathing exercise at the first stage of labor. Control group received routine care services. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum, Turkey. Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of labor. Time of the second stage was recorded as second (sec), and first minute APGAR scores of newborn were recorded. All analysis was carried out using SPSS 20. Significance was set at p<0.05.
- Conditions
- Labor Pain, Breathing Exercise
- Being tested
- BREATHING EXERCISE
- Keywords
- breath exercises, labor pain, labor duration, VAS
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATHING EXERCISEBehavioural
The intervention group was instructed on breathing exercise according to the established trial protocol.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The trial compares nulliparous pregnant in the second stage of labor instructed regarding breathing exercise with a control group that received standard care service. Receives: Behavioral: BREATHING EXERCISE |
| Control group | No intervention | control group that received standard care service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor pain
It will be measured by Visual Analog Scale (VAS)
Measured: 1 MONTH
Secondary outcomes (2)
Duration of labor
It will be measured at the second stage of labor as second.
Measured: 1 MONTH
APGAR score
It will be measured by APGAR score by on-duty pediatrician during assesment at the birth room.
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 May 2016
- Primary completion30 Jun 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Cayir, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066973
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/69
- Status last verified
- Mar 2017
- First submitted
- 21 Feb 2017
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be submitted as an article
Publications
Yuksel H, Cayir Y, Kosan Z, Tastan K. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: a randomized controlled trial. J Integr Med. 2017 Nov;15(6):456-461. doi: 10.1016/S2095-4964(17)60368-6.
PubMed 29103415
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTIVENESS OF BREATHING EXERCISES TO LABOR PAIN and DURATION: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT03066973
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/69
- Conditions
- Labor Pain, Breathing Exercise
- Keywords
- breath exercises, labor pain, labor duration, VAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 1 Mar 2017 (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 aimed to assess the efficacy of breathing exercises (BE) during the second stage of labor for maternal pain, duration of labor and first-minute APGAR score. This is a randomized controlled trial that compares nulliparous pregnant in the second stage of labor instructed regarding BE with a control group (CG) that received standard care service. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum. One session of BE training were given to pregnant in intervention group (IG). Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of birth. Time of the second stage was recorded as second (sec), and first minute APGAR scores were recorded. Significance was set at p<0.05.
Detailed description
In this trial, it is aimed to assess the effectiveness of breathing exercises (BE) for management of labor pain during the second stage of labor. Nulliparous pregnant were randomized two arms. Intervention group received breathing exercise at the first stage of labor. Control group received routine care services. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum, Turkey. Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of labor. Time of the second stage was recorded as second (sec), and first minute APGAR scores of newborn were recorded. All analysis was carried out using SPSS 20. Significance was set at p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: BREATHING EXERCISEThe trial compares nulliparous pregnant in the second stage of labor instructed regarding breathing exercise with a control group that received standard care service. |
| Control group | No intervention | –control group that received standard care service. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nullipar females
- Gestational age 37-42 week
Key exclusion criteria (3 listed)
- Analgesic and anestezice use
- Clinical instability
- Psychiatric disorders
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 |
|---|---|---|
| BREATHING EXERCISEThe intervention group was instructed on breathing exercise according to the established trial protocol. | Behavioural | Intervention group |
Primary outcome
Labor pain
Time frame: 1 MONTH
It will be measured by Visual Analog Scale (VAS)
2 secondary outcomes
Duration of labor
Time frame: 1 MONTH
APGAR score
Time frame: 1 MONTH
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 14 Mar 2017.
- Derived from this study: PubMed 29103415Yuksel H, Cayir Y, Kosan Z, Tastan K. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: a randomized controlled trial. J Integr Med. 2017 Nov;15(6):456-461. doi: 10.1016/S2095-4964(17)60368-6.
- Individual participant dataSharing planned: Yes. it will be submitted as an article
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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 BREATHING EXERCISE in people with Labor Pain and Breathing Exercise, run by Ataturk 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 2 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: finished, as of the sponsor's last update on 14 Mar 2017. 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?
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?
Labor pain (time frame: 1 MONTH). 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 NCT03066973, which also lists 1 linked publication.
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 14 Mar 2017.