AnxietyNCT02164227
Effective Use of Respiratory Patterns in the First Period of Labor in Control of Maternal Anxiety
A study testing Respiratory pattern in people with Anxiety, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The effectiveness of breathing exercise on anxiety in women during the first period of labor. Read more about this study
- Who is it for?
- Ages 12 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Respiratory pattern
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Apr 2015
- 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 12 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Primiparous
- First stage of labor
Who cannot join
- Multiple gestation;
- Eclampsia;
- Pregnancy with a dead fetus;
- Use of analgesia;
- Pregnant women with clinical instability;
- Psychiatric disorders;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Maternidade Professor Bandeira Filho
Recife, Pernambuco, 50770-400
Maria Lima, 3355-2230, humanizadora@hotmail.com
Alessandra Freire
About this study
Official title: EFFECTIVE USE OF RESPIRATORY PATTERNS IN THE FIRST PERIOD OF LABOR IN CONTROL OF MATERNAL ANXIETY: A CLINICAL TRIAL
The effectiveness of breathing exercise on anxiety in women during the first period of labor.
Read the detailed description
The groups will be randomized into intervention groups, which will be held ventilatory patterns while the control group will receive routine care service. The measurements will be made during the admission, and every 2 hours until the final phase of dilation.
- Conditions
- Anxiety
- Being tested
- Respiratory pattern
- Keywords
- anxiety, breathing exercise, labour
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory patternOther
| Study group | Role | What they receive |
|---|---|---|
| respiratory pattern | Experimental | Deep and slow inspiration is used in the initial and active stages, at which time the contractions vary from uncomfortable to strong, lumbosacral pain and cervical dilation may occur between 3 and 8 cm in this case the mother is driven to inspire slowly and the level of inspiratory reserve volume followed by slow exhalation to functional residual capacity; Sigh with post-expiratory pause that corresponds to a small spontaneous exhalation to relax occurs in tidal volume; Expiratory delay that corresponds to a prolonged propelled with the lips during the lull and expiration in the expiration time that corresponds to a slow inspiration followed by two or three puffs with the short lips will be used propelled. Receives: Other: Respiratory pattern |
| Control | No intervention | Follows the service routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
The anxiety of patients will be assessed using IDATE questionnaire
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra da Boaviagem Freire, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164227
- Sponsor's protocol ID
- 025972/2013
- Status last verified
- Jun 2014
- First submitted
- 21 May 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVE USE OF RESPIRATORY PATTERNS IN THE FIRST PERIOD OF LABOR IN CONTROL OF MATERNAL ANXIETY: A CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT02164227
- Acronym / sponsor ID
- 025972/2013
- Conditions
- Anxiety
- Keywords
- anxiety, breathing exercise, labour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 16 Jun 2014 (estimated)
- 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.
The effectiveness of breathing exercise on anxiety in women during the first period of labor.
Detailed description
The groups will be randomized into intervention groups, which will be held ventilatory patterns while the control group will receive routine care service. The measurements will be made during the admission, and every 2 hours until the final phase of dilation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| respiratory pattern | Experimental | Other: Respiratory patternDeep and slow inspiration is used in the initial and active stages, at which time the contractions vary from uncomfortable to strong, lumbosacral pain and cervical dilation may occur between 3 and 8 cm in this case the mother is driven to inspire slowly and the level of inspiratory reserve volume followed by slow exhalation to functional residual capacity; Sigh with post-expiratory pause that corresponds to a small spontaneous exhalation to relax occurs in tidal volume; Expiratory delay that corresponds to a prolonged propelled with the lips during the lull and expiration in the expiration time that corresponds to a slow inspiration followed by two or three puffs with the short lips will be used propelled. |
| Control | No intervention | –Follows the service routine |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Primiparous
- First stage of labor
Key exclusion criteria (6 listed)
- Multiple gestation;
- Eclampsia;
- Pregnancy with a dead fetus;
- Use of analgesia;
- Pregnant women with clinical instability;
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 |
|---|---|---|
| Respiratory pattern | Other | respiratory pattern |
Primary outcome
Anxiety
Time frame: 2 hours
The anxiety of patients will be assessed using IDATE questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory pattern in people with Anxiety, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 6 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 16 Jun 2014. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 2 hours). 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 16 Jun 2014.