Pain Clinical Trial
Official title:
Comparison of Maternal and Neonatal Outcomes of Early and Late Admission to the Delivery Room
NCT number | NCT06344741 |
Other study ID # | sdilek6 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 13, 2023 |
Est. completion date | July 31, 2024 |
This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Ages 18 and over, - At term gestational age (37-42 weeks), - Does not have a risky pregnancy, - Single pregnancy, - Head presentation, - Literate participants will be included Exclusion Criteria: - Those who do not have sufficient mental health to fill out the survey form, - Visual, hearing, perception impaired - The newborn is unhealthy or stillborn, - With membrane rupture - Having a history of cesarean section - Those who have contraindications for vaginal birth - Having complaints of pregnancy-related bleeding, - Any risk of birth (placental abruption, uterine rupture, etc.) - Willing to leave at any point during the research |
Country | Name | City | State |
---|---|---|---|
Turkey | Kocaeli University | Kocaeli |
Lead Sponsor | Collaborator |
---|---|
Kocaeli University |
Turkey,
Lundqvist P, Kleberg A, Edberg AK, Larsson BA, Hellstrom-Westas L, Norman E. Development and psychometric properties of the Swedish ALPS-Neo pain and stress assessment scale for newborn infants. Acta Paediatr. 2014 Aug;103(8):833-9. doi: 10.1111/apa.12672. Epub 2014 May 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal pain and stress | ALPS-Neo: It is a 3-point Likert type scale consisting of 5 items: facial expression of the newborn, breathing pattern, tone of extremities, hand and foot activities and activity level. Measurements are made through observation. As stress and pain increase, the score obtained also increases. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and above 5 points indicate the presence of serious pain and stress. | 15th minute after birth | |
Primary | Birth satisfaction | Birth satisfaction will be measured with a 10cm line visual analogue scale. The participant will be asked about her satisfaction with the birth and will be asked to mark his or her satisfaction on a visual analogue scale. The lowest score from the scale is 0, the highest score is 10. | 5th hour postpartum | |
Secondary | Maternal Anxiety | Maternal anxiety will be measured with the State and Trait Anxiety Inventory (STAI) during contraction monitoring. The scale consists of two subscales: state and continuous, each consisting of 20 questions. It is a Likert-type scale with points between 1 and 4 for each question, and can be applied to individuals over the age of 14. The lowest score from each of the scales is 20 points and the highest score is 80 points. | During the first 10 minutes of the participant's admission to the delivery room | |
Secondary | Fear of Birth | It will be measured with the Fear of Birth Scale during contraction follow-up. Responses to each item in the scale range from 1 to 10, with 1 indicating "I completely disagree" and 10 indicating "I completely agree". The minimum score that can be obtained from the scale is 10 and the maximum score is 100. A high score from the scale indicates high fear. | During the first 10 minutes of the participant's admission to the delivery room |
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