NCT02164227

Brief Summary

The effectiveness of breathing exercise on anxiety in women during the first period of labor.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

May 21, 2014

Last Update Submit

June 12, 2014

Conditions

Keywords

anxietybreathing exerciselabour

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    The anxiety of patients will be assessed using IDATE questionnaire

    2 hours

Study Arms (2)

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.

Other: Respiratory pattern

Control

NO INTERVENTION

Follows the service routine

Interventions

respiratory pattern

Eligibility Criteria

Age12 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primiparous
  • First stage of labor

You may not qualify if:

  • Multiple gestation;
  • Eclampsia;
  • Pregnancy with a dead fetus;
  • Use of analgesia;
  • Pregnant women with clinical instability;
  • Psychiatric disorders;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternidade Professor Bandeira Filho

Recife, Pernambuco, 50770-400, Brazil

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

May 21, 2014

First Posted

June 16, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

April 1, 2015

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations