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Effects of Digital Vaginal Examination During Labor on Pain and Anxiety Levels

Effects of Digital Vaginal Examination During Labor on Pain and Anxiety : a Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02599610
Enrollment
40
Registered
2015-11-06
Start date
2015-10-31
Completion date
2016-03-31
Last updated
2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labor, Pregnancy

Keywords

labor, vaginal examination, transperineal ultrasound, pain, anxiety

Brief summary

Digital vaginal examination is the most common method for assessing progress of labor and delivery. Considering it is the most common intervention women receive during course of labor, evidence for psychological effects of digital vaginal examination on women is surprisingly sparse. Reducing the number of vaginal examination during labor has been proposed by many authors as benefit of more vaginal examination is unclear. However this is unlikely to happen until more research on the topic demonstrates clear detrimental effects of vaginal examination. Our study is aimed at investigating association of vaginal examination with psychological distress of women during labor. Anxiety during labor is associated with longer labor duration, increased perception of pain, problems with newborn attachment, and increased rates of postpartum depression and post-traumatic stress disorder. In this study, women were assigned to either digital vaginal examination or transperineal ultrasound assessment groups were compared to each other in a randomised controlled setting.

Interventions

OTHERDigital vaginal examination

Patients will be subject to digital vaginal examinations every four hours during latent phase of first stage, hourly during active phase of first stage and as needed during second stage.

DEVICETransperineal ultrasound examination

Patients will be subject to transperineal ultrasound examinations every four hours during latent phase of first stage, hourly during active phase of first stage and as needed during second stage.

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Multiparous women * Spontaneous active labor * Cephalic presentation

Exclusion criteria

* Women with known psychiatric disorders * Labor induction * Advanced labor during admission (Dilatation greater than 7cm) * Presence of a prenatally diagnosed anomaly in fetus * Admission to neonatal intensive care unit after delivery * Delayed hospital discharge due to excessive weight loss of neonate

Design outcomes

Primary

MeasureTime frameDescription
Anxiety levelsBetween 12 to 48 hoursAnxiety levels of the patients will be assessed with the State-Trait Anxiety Inventory (STAI) questionnaire during admission, at the beginning of active phase of stage one and four hours after delivery.
Labor painBetween 12 to 48 hoursPerceived pain level of the patients will be assessed with Visual Analog Scale (VAS) questionnaire during admission, at the beginning of active phase of stage one and four hours after delivery.

Countries

Turkey (Türkiye)

Contacts

Primary ContactErkan Kalafat, MD
ekalafat@ankara.edu.tr05334736998

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026