Labor HopscotchNCT06879405
The Effect of Labour Hopscotch Based Midwifery Care in Labor
A study testing The Labor Hopscotch in people with Labor Hopscotch, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. 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
- Labor Hopscotch
- What is being tested?
- The Labor Hopscotch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- Being over 45 years
- Multiparity
- High-risk pregnancy
- Progressing labor
- Having a diagnosed psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Labour Hopscotch Based Midwifery Care in Labor on Birth Outcomes, Labor Pain, Birth Comfort and Satisfaction: Randomized Controlled Study
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.
Read the detailed description
Experimental Group: Midwifery care based on labor hopscotch was applied. The midwife performed the practices in labor hopscotch step by step in the experimental group. The practices started when the dilation was 4-5 cm and each practice lasted 20 minutes. A 30-minute break was given between the practices. Visual posters showing the practice steps were hung in the delivery rooms. According to the visual poster, the pregnant woman approaches the baby's footprint with each step she takes, and this situation increases the pregnant woman's motivation while ensuring her active participation in the practices. In women who experienced discomfort during the practices, the practices were paused for 10-15 minutes and then tried again. In case of discomfort again, the practices were not continued and the pregnant woman was removed from the study group.
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).
Control Group: Pregnant women in this group continued to receive routine delivery room midwifery care in accordance with the concept of a mother-friendly hospital. Pregnant women give birth with minimal intervention and invasive procedures. If deemed necessary by the physician, interventions such as induction, propess, amniotomy, forceps/vacuum can be performed. NST is evaluated once an hour and vaginal examination is performed once every 2 hours (durations may vary according to the physician's request). If the pregnant woman wishes, labor can be monitored with a companion of her choice. Unless otherwise indicated, oral intake of pregnant women is not restricted.
Both experimental and control groups; In labor follow-up; Birth outcomes form was applied. In the experimental group, VAS application was applied after each of the 7 application steps in the labor hopscotch application and when the cervical dilatation was 4-5 cm, 8 cm, 10 cm. In the control group, VAS application was applied when the cervical dilatation was 4-5 cm, 8 cm, 10 cm. Birth Comfort Scale was applied to the pregnant women in the experimental and control groups when the cervical dilatation was 8-10 cm.
In the second stage of labor; Birth outcomes form and VAS application were applied to the pregnant women in both groups.
In the 3rd stage of labor; perineal laceration form was used for evaluation of the pregnant women in both groups.
Within the first 2 hours after birth; VAS and Birth Satisfaction Scale Revised Form were applied to the pregnant women in both groups.
- Conditions
- Labor Hopscotch
- Being tested
- The Labor Hopscotch
- Keywords
- labor hopscotch, midwife, labor pain, birth satisfaction, midwifery care
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Labor HopscotchOther
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 group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group: Midwifery care based on labor hopscotch was applied. The midwife performed the practices in labor hopscotch step by step in the experimental group. The practices started when the dilation was 4-5 cm and each practice lasted 20 minutes. A 30-minute break was given between the practices. Visual posters showing the practice steps were hung in the delivery rooms. According to the visual poster, the pregnant woman approaches the baby's footprint with each step she takes, and this situation increases the pregnant woman's motivation while ensuring her active participation in the practices. In women who experienced discomfort during the practices, the practices were paused for 10-15 minutes and then tried again. In case of discomfort again, the practices were not continued and the pregnant woman was removed from the study group. Receives: Other: The Labor Hopscotch |
| control group | No intervention | Control Group: Pregnant women in this group continued to receive routine delivery room midwifery care in accordance with the concept of a mother-friendly hospital. Pregnant women give birth with minimal intervention and invasive procedures. If deemed necessary by the physician, interventions such as induction, propess, amniotomy, forceps/vacuum can be performed. NST is evaluated once an hour and vaginal examination is performed once every 2 hours (durations may vary according to the physician's request). If the pregnant woman wishes, labor can be monitored with a companion of her choice. Unless otherwise indicated, oral intake of pregnant women is not restricted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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.
Measured: VAS will be applied during labor (after active phase).
Birth Outcomes Form
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.
Measured: Birth outcomes form will apply immediately after birth (second stage of labor).
Perineal Laceration Evaluation Form
The form is a form created to evaluate postpartum episiotomy, perineal and cervical laceration status.
Measured: Perineal laceration form will be apply immediately delivery of the placenta (In the 3rd stage of labor).
Birth Comfort Scale
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.
Measured: Birth Comfort Scale will be apply before the baby is born.
Birth Satisfaction Scale Revised Form
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.
Measured: Birth Satisfaction Scale Revised Form will be apply within the first 2 hours after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Dec 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor HopscotchStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Model description
- The research is a randomized controlled experimental design.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Akpınar, Ataturk University
- Investigators
- Ayla Kanbur, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879405
- Sponsor's protocol ID
- AtaturkU.
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Labour Hopscotch Based Midwifery Care in Labor on Birth Outcomes, Labor Pain, Birth Comfort and Satisfaction: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06879405
- Acronym / sponsor ID
- AtaturkU.
- Conditions
- Labor Hopscotch
- Keywords
- labor hopscotch, midwife, labor pain, birth satisfaction, midwifery care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 17 Mar 2025 (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.
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.
Detailed description
Experimental Group: Midwifery care based on labor hopscotch was applied. The midwife performed the practices in labor hopscotch step by step in the experimental group. The practices started when the dilation was 4-5 cm and each practice lasted 20 minutes. A 30-minute break was given between the practices. Visual posters showing the practice steps were hung in the delivery rooms. According to the visual poster, the pregnant woman approaches the baby's footprint with each step she takes, and this situation increases the pregnant woman's motivation while ensuring her active participation in the practices. In women who experienced discomfort during the practices, the practices were paused for 10-15 minutes and then tried again. In case of discomfort again, the practices were not continued and the pregnant woman was removed from the study group.
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).
Control Group: Pregnant women in this group continued to receive routine delivery room midwifery care in accordance with the concept of a mother-friendly hospital. Pregnant women give birth with minimal intervention and invasive procedures. If deemed necessary by the physician, interventions such as induction, propess, amniotomy, forceps/vacuum can be performed. NST is evaluated once an hour and vaginal examination is performed once every 2 hours (durations may vary according to the physician's request). If the pregnant woman wishes, labor can be monitored with a companion of her choice. Unless otherwise indicated, oral intake of pregnant women is not restricted.
Both experimental and control groups; In labor follow-up; Birth outcomes form was applied. In the experimental group, VAS application was applied after each of the 7 application steps in the labor hopscotch application and when the cervical dilatation was 4-5 cm, 8 cm, 10 cm. In the control group, VAS application was applied when the cervical dilatation was 4-5 cm, 8 cm, 10 cm. Birth Comfort Scale was applied to the pregnant women in the experimental and control groups when the cervical dilatation was 8-10 cm.
In the second stage of labor; Birth outcomes form and VAS application were applied to the pregnant women in both groups.
In the 3rd stage of labor; perineal laceration form was used for evaluation of the pregnant women in both groups.
Within the first 2 hours after birth; VAS and Birth Satisfaction Scale Revised Form were applied to the pregnant women in both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research is a randomized controlled experimental design.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: The Labor HopscotchExperimental Group: Midwifery care based on labor hopscotch was applied. The midwife performed the practices in labor hopscotch step by step in the experimental group. The practices started when the dilation was 4-5 cm and each practice lasted 20 minutes. A 30-minute break was given between the practices. Visual posters showing the practice steps were hung in the delivery rooms. According to the visual poster, the pregnant woman approaches the baby's footprint with each step she takes, and this situation increases the pregnant woman's motivation while ensuring her active participation in the practices. In women who experienced discomfort during the practices, the practices were paused for 10-15 minutes and then tried again. In case of discomfort again, the practices were not continued and the pregnant woman was removed from the study group. |
| control group | No intervention | –Control Group: Pregnant women in this group continued to receive routine delivery room midwifery care in accordance with the concept of a mother-friendly hospital. Pregnant women give birth with minimal intervention and invasive procedures. If deemed necessary by the physician, interventions such as induction, propess, amniotomy, forceps/vacuum can be performed. NST is evaluated once an hour and vaginal examination is performed once every 2 hours (durations may vary according to the physician's request). If the pregnant woman wishes, labor can be monitored with a companion of her choice. Unless otherwise indicated, oral intake of pregnant women is not restricted. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being literate
- Being between 18-45 years old
- Primigravida
- Having a single fetus
- Cervical dilatation of at most 4-5 cm
Key exclusion criteria (5 listed)
- Being over 45 years
- Multiparity
- High-risk pregnancy
- Progressing labor
- Having a diagnosed psychiatric illness
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 |
|---|---|---|
| The Labor HopscotchLabor 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). | Other | Experimental Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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.
Ayla Kanbur principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Labor Hopscotch in people with Labor Hopscotch, run by Ataturk 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (VAS) (time frame: VAS will be applied during labor (after active phase).). The study lists 5 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 17 Mar 2025.