NCT06783972

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

January 19, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2025

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 15, 2025

Last Update Submit

January 30, 2026

Conditions

Keywords

midwiferyvaginal birthtouching

Outcome Measures

Primary Outcomes (1)

  • Mother-Baby Interaction

    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.

Study Arms (2)

Group 1

NO INTERVENTION

Routine labor monitoring

Group 2

EXPERIMENTAL

fetal head touching practice

Behavioral: Touching

Interventions

TouchingBEHAVIORAL

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.

Group 2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Leaving the study before it is completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

Related Links

MeSH Terms

Interventions

Touch

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

January 19, 2025

Primary Completion

March 16, 2025

Study Completion

April 16, 2025

Last Updated

February 3, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Data security

Locations