Birth Self-efficacyNCT06442917
The Effect of Breathing Exercise and Affirmation Method Used in Labor on Women's Birth Self-Efficacy and Satisfaction
A study testing Breathing Exercise, Affirmation Method and Breathing Exercise and Affirmation Method in people with Birth Self-efficacy and Birth Satisfaction, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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… 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
- Birth Self-efficacy, Birth Satisfaction
- What is being tested?
- Breathing Exercise, Affirmation Method and Breathing Exercise and Affirmation Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2022to 30 Nov 2022
- 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
- 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
Who cannot join
- Your mother wants to leave without working, * Pregnant women who developed cesarean section indication after being included in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study was conducted in four groups. Groups; The group in which the affirmation method was used in labor (Affirmation Group - OG), the group in which breathing exercises were used in labor (Breathing Group - NG), the group in which both breathing exercises and affirmation methods were used in labor (Breathing and Affirmation Group - NOG), and the group in which no intervention was made other than routine hospital practices. It is divided into a non-existent group (Control Group - CG). The numbers given to the groups (1, 2, 3, 4) were determined by the lottery method. The name of each group was written on the papers and numbered in order of drawing. The numbers 3 were assigned to the Breathing group, 1 to the Affirmation group, 2 to the Breathing and Affirmation group, and 4 to the Control group. Considering data loss in the distribution of the study into groups, numbers from 1 to 200 were randomized for 4 groups using a computer-assisted randomization program (https://www.rstudio.com). In order to ensure homogeneity in the randomization of the intervention groups and the control group, five matching criteria were taken into consideration. These match criteria; It was determined as the mother's age, education level (secondary school and below, high school and above), employment status (working/not working), gestational age, and prenatal education. Homogeneity of the groups was tested in the evaluation of the study.
Pregnant women to be included in the study were assigned to groups according to the numbers in the columns according to the eligibility criteria. In order to avoid being influenced by each other, pregnant women were included in the study one by one, and after the birth of one pregnant woman was completed, the other pregnant woman was included in the study.
- Conditions
- Birth Self-efficacy, Birth Satisfaction
- Being tested
- Breathing Exercise, Affirmation Method, Breathing Exercise and Affirmation Method
- Keywords
- self-efficacy, self-satisfaction, breathing exercise, affirmation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExerciseBehavioural
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.
Affirmation MethodBehavioural
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.
Breathing Exercise and Affirmation MethodBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Breathing Exercise and Affirmation Method |
| control group | No intervention | Routine midwifery care was applied during the trauma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: in the active phase of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Apr 2022
- Primary completion31 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth Self-efficacyStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Collaborators
- Mehmet Akif Ersoy Canakkale State Hospital
- Responsible party
- Principal investigator, Remziye Gültepe, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442917
- Sponsor's protocol ID
- 20.478.486/1213
- Status last verified
- Jun 2024
- First submitted
- 22 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise and Affirmation Method Used in Labor on Women's Birth Self-Efficacy and Satisfaction
- ClinicalTrials.gov ID
- NCT06442917
- Acronym / sponsor ID
- 20.478.486/1213
- Conditions
- Birth Self-efficacy, Birth Satisfaction
- Keywords
- self-efficacy, self-satisfaction, breathing exercise, affirmation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Collaborators
- Mehmet Akif Ersoy Canakkale State Hospital
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 4 Jun 2024 (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: 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.
Detailed description
This study was conducted in four groups. Groups; The group in which the affirmation method was used in labor (Affirmation Group - OG), the group in which breathing exercises were used in labor (Breathing Group - NG), the group in which both breathing exercises and affirmation methods were used in labor (Breathing and Affirmation Group - NOG), and the group in which no intervention was made other than routine hospital practices. It is divided into a non-existent group (Control Group - CG). The numbers given to the groups (1, 2, 3, 4) were determined by the lottery method. The name of each group was written on the papers and numbered in order of drawing. The numbers 3 were assigned to the Breathing group, 1 to the Affirmation group, 2 to the Breathing and Affirmation group, and 4 to the Control group. Considering data loss in the distribution of the study into groups, numbers from 1 to 200 were randomized for 4 groups using a computer-assisted randomization program (https://www.rstudio.com). In order to ensure homogeneity in the randomization of the intervention groups and the control group, five matching criteria were taken into consideration. These match criteria; It was determined as the mother's age, education level (secondary school and below, high school and above), employment status (working/not working), gestational age, and prenatal education. Homogeneity of the groups was tested in the evaluation of the study.
Pregnant women to be included in the study were assigned to groups according to the numbers in the columns according to the eligibility criteria. In order to avoid being influenced by each other, pregnant women were included in the study one by one, and after the birth of one pregnant woman was completed, the other pregnant woman was included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Experimental | Behavioral: Breathing Exercise32 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. |
| Affirmation Method Group | Experimental | Behavioral: Affirmation Method32 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. |
| Breathing Exercise and Affirmation Method Group | Experimental | Behavioral: Breathing Exercise and Affirmation MethodDuring 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. |
| control group | No intervention | –Routine midwifery care was applied during the trauma. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The one who is open to communication,
- between the ages of 18-45 Dec,
- At least a primary school graduate,
- Non-risky pregnancy in terms of mother and baby (multiple pregnancy, preeclampsia, etc.),
- Living at term and having a single pregnancy,
Key exclusion criteria (1 listed)
- Your mother wants to leave without working, * Pregnant women who developed cesarean section indication after being included in the study
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 Exercise32 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. | Behavioural | Breathing Exercise Group |
| Affirmation Method32 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. | Behavioural | Affirmation Method Group |
| Breathing Exercise and Affirmation MethodDuring 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 | Behavioural | Breathing Exercise and Affirmation Method Group |
Primary outcome
birth self-efficacy scale
Time frame: in the active phase of labor
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.
birth satisfaction scale
Time frame: in the active phase of labor
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.
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 6 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercise, Affirmation Method and Breathing Exercise and Affirmation Method in people with Birth Self-efficacy and Birth Satisfaction, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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 8 inclusion and 1 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 6 Jun 2024. 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 Turkey (Türkiye). 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?
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?
birth self-efficacy scale (time frame: in the active phase of labor). The study lists 2 primary outcomes in all. 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 6 Jun 2024.