- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06783972
The Effect of Touching the Fetal Head During the Perineal Crowning Phase (Touching)
January 30, 2026 updated by: Dilek Mamik Aktay, Ege University
The Effect of Touching the Fetal Head of the Pregnant on the Duration of the Second Stage of Labor and the Mother-Baby Interaction During the Perineal Crowning Phase
In this study, it is planned to shorten the second stage of labor by touching the fetal head during the second stage of labor.
It is thought that touching will also have positive effects on the mother and the newborn.
The fact that touching the fetal head is a cost-free and easily applicable action is a different and strong aspect from other studies.
This research study that we have planned is quite meaningful in terms of ensuring a comfortable postpartum period within the scope of mother and baby-friendly practices that our Ministry emphasizes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bornova
-
Izmir, Bornova, Turkey (Türkiye), 35040
- Ege University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Not to have obstetric risk,
- To be primiparous,
- To be 37W and above pregnant,
- To carry a live fetus,
- To be mentally healthy,
- To be able to communicate,
- To be literate,
- To have no systemic disease,
- To not use medication for any reason,
- To have no addiction, no movement restriction
Exclusion Criteria:
- Leaving the study before it is completed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group 1
Routine labor monitoring
|
|
|
Experimental: Group 2
fetal head touching practice
|
In the second stage of birth, when the baby's head crowns, the mother is allowed to touch the baby's head as much as she wants and with as many fingers as she wants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mother-Baby Interaction
Time Frame: This scale was applied on the 1st and 2nd day after birth.
|
The research output will be evaluated with the Mother-Infant Interaction Scale.
This scale is a three-point Likert-type scale from positive to negative, aiming to determine the mother's responses, reactions and closeness to her baby in the early postpartum period.
There are 5 behavioral classifications for the mother in each scale.
These are grouped as; Sensitivity for the baby, Touching/holding, Eye-to-eye and face-to-face communication, Providing adequate care, Expressing feelings.
In order to obtain a full score on the scale; the item that gives the best description from each of the five behavioral categories is marked.
Each item in the five behavioral categories is grouped by giving "2,1,0" points.
At the end of the observation, each category is scored and a total score is obtained.
The scale is applied by observing the behaviors of the mother and her baby during the first contact and the 2nd day after birth.
With the scores obtained, the midwife determines the
|
This scale was applied on the 1st and 2nd day after birth.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Feldman R, Singer M, Zagoory O. Touch attenuates infants' physiological reactivity to stress. Dev Sci. 2010 Mar;13(2):271-8. doi: 10.1111/j.1467-7687.2009.00890.x.
- Goldstein P, Weissman-Fogel I, Shamay-Tsoory SG. The role of touch in regulating inter-partner physiological coupling during empathy for pain. Sci Rep. 2017 Jun 12;7(1):3252. doi: 10.1038/s41598-017-03627-7.
- Hertenstein MJ, Keltner D, App B, Bulleit BA, Jaskolka AR. Touch communicates distinct emotions. Emotion. 2006 Aug;6(3):528-33. doi: 10.1037/1528-3542.6.3.528.
- Sehlstedt I, Ignell H, Backlund Wasling H, Ackerley R, Olausson H, Croy I. Gentle touch perception across the lifespan. Psychol Aging. 2016 Mar;31(2):176-84. doi: 10.1037/pag0000074.
- Tang Y, Benusiglio D, Lefevre A, Hilfiger L, Althammer F, Bludau A, Hagiwara D, Baudon A, Darbon P, Schimmer J, Kirchner MK, Roy RK, Wang S, Eliava M, Wagner S, Oberhuber M, Conzelmann KK, Schwarz M, Stern JE, Leng G, Neumann ID, Charlet A, Grinevich V. Social touch promotes interfemale communication via activation of parvocellular oxytocin neurons. Nat Neurosci. 2020 Sep;23(9):1125-1137. doi: 10.1038/s41593-020-0674-y. Epub 2020 Jul 27.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2025
Primary Completion (Actual)
March 16, 2025
Study Completion (Actual)
April 16, 2025
Study Registration Dates
First Submitted
January 15, 2025
First Submitted That Met QC Criteria
January 15, 2025
First Posted (Actual)
January 20, 2025
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 30, 2026
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ethics Committee Number 942
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data security
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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