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

Not Applicable

• Conditions: Pregnancy; Obstetric Labor
• Interventions: Device: Transperineal ultrasound examination; Other: Digital vaginal examination

• Registration Number: NCT02599610
• Lead Sponsor: Ankara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-14
• Last Update Posted: 2016-02-17
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transperineal ultrasound examination	Transperineal ultrasound examination	Patients assigned to this group will be followed-up with transperineal ultrasound examinations as described in intervention protocol.
Digital vaginal examination	Digital vaginal examination	Patients assigned to this group will be followed-up with digital vaginal examinations as described in intervention protocol.

Primary Outcome Measures

Name	Time	Method
Anxiety levels	Between 12 to 48 hours	Anxiety 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 pain	Between 12 to 48 hours	Perceived 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.

Trial Locations

Locations (1)

Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology; 🇹🇷 Ankara, Turkey