NCT06442917

Brief Summary

Purpose: This research was conducted to determine the effect of breathing exercise and affirmation method used in labor on women's birth self-efficacy and satisfaction. Materials and Methods: The sample of the study, in which the randomized controlled experimental design type was applied, consisted of 128 nulliparous pregnant women. Data were collected with Pregnant Descriptive Information Form, Innate Period Evaluation Form, Visual Analog Scale, Affirmation Statement Evaluation Form, Short Form of the Childbirth of Self-Efficacy Inventory and Birth Satisfaction Scale. Pregnant women who are in the first stage of labor have been using diaphragmatic breathing exercise to one group, affirmation method to one group, both diaphragmatic exercise and affirmation method to one group since the active phase, while pregnant women in the control group have not been given any intervention, they have received routine care. Descriptive statistical methods, chi-square test, one-way analysis of variance, t-test for dependent and independent groups were used in the analysis of the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

May 22, 2024

Last Update Submit

June 5, 2024

Conditions

Keywords

self-efficacyself-satisfactionbreathing exerciseaffirmation

Outcome Measures

Primary Outcomes (2)

  • birth self-efficacy scale

    birth self-efficacy of pregnant women.The lowest total score that can be obtained from the scale is 32, and the highest total score is 320. As the scores from the scale increase, the self-efficacy levels of pregnant women in labor increase.

    in the active phase of labor

  • birth satisfaction scale

    birth satisfaction of pregnant women.As a result of the scale, a score between 0 and 40 is received. It is interpreted that as the score obtained as a result of the scale increases, the woman's birth satisfaction increases, while a low score indicates that the birth satisfaction is not at a sufficient level.

    in the active phase of labor

Study Arms (4)

Breathing Exercise Group

EXPERIMENTAL

32 the Pregnant Identifying Characteristics Form, the Short Version of the Self-Efficacy Scale in Childbirth was completed before the pregnancy intervention and the VAS was measured.

Behavioral: Breathing Exercise

Affirmation Method Group

EXPERIMENTAL

32 pregnant women who were admitted to the hospital for childbirth and were in the latent phase (0-3 cm) filled out the pre-intervention Pregnant Identifying Characteristics Form, the Short Version of the Self-Efficacy Scale in Childbirth, and the VAS was measured.

Behavioral: Affirmation Method

Breathing Exercise and Affirmation Method Group

EXPERIMENTAL

During the latent phase, affirmation phrases were shown to the pregnant women and the application was explained and the application was made with breathing exercise training.

Behavioral: Breathing Exercise and Affirmation Method

control group

NO INTERVENTION

Routine midwifery care was applied during the trauma.

Interventions

32 the Pregnant Identifying Characteristics Form, the Short Version of the Self-Efficacy Scale in Childbirth was completed before the pregnancy intervention and the VAS was measured. Breathing exercise training and application were carried out during the latent phase process. In this training, the importance of proper breathing was explained and diaphragmatic breathing application was made. During the active phase process (4-7 cm), the Innatal Period Evaluation Form was filled out and the VAS was measured, and diaphragmatic breathing exercise was performed every 30 minutes from the beginning of contraction until the end of contraction. During the transition phase (8-10 cm), the Innatal Period Evaluation Form, the Short Version of the Self-Efficacy Scale in Childbirth were filled out and the VAS was measured, and diaphragmatic breathing exercise was performed once every 15 minutes from the beginning of contraction to the end of contraction.

Breathing Exercise Group

32 pregnant women who were admitted to the hospital for childbirth and were in the latent phase (0-3 cm) filled out the pre-intervention Pregnant Identifying Characteristics Form, the Short Version of the Self-Efficacy Scale in Childbirth, and the VAS was measured. During the latent phase, affirmation phrases were shown to the pregnant women and the application was explained. During the active phase process (4-7 cm), the Innatal Period Evaluation Form was filled out and the VAS was measured, and the affirmation phrases were repeated and used by the researcher every 30 minutes from the beginning of the contraction until the end of the contraction. During the transition phase (8-10 cm), the Innatal Period Evaluation Form, the Short Version of the Self-Efficacy Scale in Childbirth were filled out and the VAS was measured, and affirmation sentences and support sentences were said every 15 minutes from the beginning of the contraction to the end of the contraction.

Affirmation Method Group

During the latent phase, affirmation phrases were shown to the pregnant women and the application was explained and the application was made with breathing exercise training. In this training, the importance of proper breathing was explained and diaphragmatic breathing application was made. During the active phase process (4-7 cm), the Congenital Period Evaluation Form was filled out and the VAS was measured, and diaphragmatic breathing exercise was performed once every 30 minutes from the beginning of contraction to the end of contraction, and the affirmation phrases were repeated and used by the researcher

Breathing Exercise and Affirmation Method Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWoman
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The one who is open to communication,
  • between the ages of 18-45 Dec,
  • At least a primary school graduate,
  • \* Nulliparous,
  • Non-risky pregnancy in terms of mother and baby (multiple pregnancy, preeclampsia, etc.),
  • \* In the first stage of labor (0-3 cm dilatation), which is,
  • Living at term and having a single pregnancy,
  • No analgesic or anesthetic substance is applied during the trauma, \* Pregnant women who volunteer to participate in the research

You may not qualify if:

  • Your mother wants to leave without working, \* Pregnant women who developed cesarean section indication after being included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çanakkale Onsekiz Mart Üniversitesi

Çanakkale, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 4, 2024

Study Start

April 10, 2022

Primary Completion

October 31, 2022

Study Completion

November 30, 2022

Last Updated

June 6, 2024

Record last verified: 2024-06

Locations