The Effect of Labour Hopscotch Based Midwifery Care in Labor

NCT06879405 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-17

No results posted yet for this study

Summary

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.

Conditions

  • Labor Hopscotch

Interventions

OTHER

The Labor Hopscotch

Labor Hopscotch consists of 4 basic parameters including movement (mobilization), positioning (birth stool, sitting on the toilet, birth ball, birth mat), water therapy and non-pharmacological methods for reducing pain. There are sub-contents for each of these parameters and hopscotch consists of 7 steps in total. Labor Hopscotch Model Steps; Step 1: Mobilization (squat, pelvic tilt, using stairs, movement) Step 2: Birth Stool (oral fluid support, massage, breathing techniques) Step 3: Sitting on the Toilet (urinating, dim lighting, music) Step 4: Water Therapy (Warm shower, breathing techniques, Squat, oral fluid support) Step 5: Birth Ball (drawing 8 with the birth ball, slow movement techniques) Step 6: Birth Mat (massage, exercise on the mat, quadruped position) Step 7: Alternative Methods (massage, aromatherapy).

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Principal Investigators

  • Ayla Kanbur · Ataturk University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06879405 on ClinicalTrials.gov