Ireland
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The Effect of Labour Hopscotch Based Midwifery Care in Labor

NCT06879405 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2023-12-01
Last updated
2025-03-17

Condition(s) studied

Labor Hopscotch

Investigational drug(s) / intervention(s)

The Labor Hopscotch

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).

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Being literate * Being between 18-45 years old * Primigravida * Having a single fetus * Cervical dilatation of at most 4-5 cm * Being open to communication * Voluntarily participating in the study Exclusion Criteria: * Being over 45 years * Multiparity * High-risk pregnancy * Progressing labor * Having a diagnosed psychiatric illness

Primary outcome measure(s)

  • Visual Analog Scale (VAS) — VAS will be applied during labor (after active phase).
    VAS is used to measure perceived pain. The scale has numbers from 1 to 10 on a vertical line. Number 1 symbolize almost none and number 10 symbolizes severe pain.
  • Birth Outcomes Form — Birth outcomes form will apply immediately after birth (second stage of labor).
    The form includes 13 questions that evaluate the duration of labor stages, interventions used during labor (induction, amniotomy, propess application, vacuum/forceps, other situations), data regarding the newborn (gender, height, weight, APGAR score, oxygen saturation, complication status, special care status), and satisfaction with the birth control application steps.
  • Perineal Laceration Evaluation Form — Perineal laceration form will be apply immediately delivery of the placenta (In the 3rd stage of labor).
    The form is a form created to evaluate postpartum episiotomy, perineal and cervical laceration status.
  • Birth Comfort Scale — Birth Comfort Scale will be apply before the baby is born.
    The scale consists of 9 items and 3 sub-dimensions (physical, psychospiritual and environmental). Each item is expected to be answered considering the comfort in the delivery room. Each item in the scale is scored between 1-5 (1=Strongly disagree, 2=Mostly disagree, 3=Partially agree, 4=Mostly agree, 5=Totally agree). The minimum score that can be obtained from the scale is 9, and the maximum score is 45. As the score increases, it indicates a high level of comfort, and as it decreases, it indicates a low level of comfort.
  • Birth Satisfaction Scale Revised Form — Birth Satisfaction Scale Revised Form will be apply within the first 2 hours after birth.
    It is a measurement tool consisting of 10 items and 3 sub-dimensions, applied to women who gave birth normally in the first ten days postpartum.6 items on the scale are positive, 4 items are negative, and 4 items are reverse scored. As the score on the scale increases, the woman's birth satisfaction increases.Birth Satisfaction Scale Revised Form will be apply to the pregnant women in both groups.

Trial sites (1)

FacilityCityRegionStatus
Ataturk University Erzurum yakutiye
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06879405 on ClinicalTrials.gov ↗ ← All trials in Turkey