The Effect of Labour Hopscotch Based Midwifery Care in Labor

This study aimed to evaluate the effects of labor hopscotch midwifery care on birth outcomes, labor pain, birth comfort and satisfaction. The research is a randomized controlled experimental design. The study will be conducted between June 1, 2024 and December 1, 2025 at the Tuzla State Hospital Maternity Unit affiliated with the Istanbul Provincial Health Directorate. The universe of the study consists of primiparous pregnant women who applied to the relevant maternity ward. A priori power analysis was used to determine the sample size of the study. The sample size was determined using the G\*Power program version 3.1.9.7 (Heinrich-Heini-Universitat-Düsseldorf, Germany) and Cohen's standard effect sizes were used as a reference method in the power analysis. The sample size was calculated as 84 pregnant women (Experimental group: 42 pregnant women, Control group: 42 pregnant women). It was decided to collect data from a total of 100 pregnant women by including a 20% spare sample in case of data loss. For randomization, columns between 1-100 were created in the system using the Random Integer Generator method under the Numbers subheading of the random.org website. Considering the numbers 1 and 2 in the column, pregnant women who came to the delivery room were randomly assigned to these numbers (https://www.random.org/). Which number constituted which group was determined by drawing lots at the beginning of the study, and the result of the drawing was determined as 1 control group and 2 experimental groups. Experimental and control group data were collected simultaneously. In collecting the data, the Introductory Information Form, Birth Outcomes Form, Perineal Laceration Assessment Form, Visual Analog Scale (VAS), Birth Comfort Scale and Birth Satisfaction Scale Revised Form were used. In collecting the data, the Introductory Information Form, Birth Outcomes Form, Perineal Laceration Assessment Form, Visual Analog Scale (VAS), Birth Comfort Scale and Birth Satisfaction Scale Revised Form were used.

NCT Number	NCT06879405
Lead Sponsor	Ataturk University
Conditions	Labor Hopscotch
Enrollment	100 participants
Start Date	2023-12-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2025-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-17