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

NCT02599610 | Unknown

• 1 other identifier: 006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Obstetric Labor

Keywords

labor, vaginal examination, transperineal ultrasound, pain, anxiety

Outcome Measures

Primary Outcomes (2)

• Anxiety levels

  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.

  Between 12 to 48 hours

• Labor pain

  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.

  Between 12 to 48 hours

Study Arms (2)

Digital vaginal examination

ACTIVE COMPARATOR

Patients assigned to this group will be followed-up with digital vaginal examinations as described in intervention protocol.

Other: Digital vaginal examination

Transperineal ultrasound examination

EXPERIMENTAL

Patients assigned to this group will be followed-up with transperineal ultrasound examinations as described in intervention protocol.

Device: Transperineal ultrasound examination

Interventions

Digital vaginal examination OTHER

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.

Digital vaginal examination

Transperineal ultrasound examination DEVICE

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.

Transperineal ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiparous women
• Spontaneous active labor
• Cephalic presentation

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Erkan Kalafat, MD

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erkan Kalafat, MD

CONTACT

05334736998; ekalafat@ankara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 6, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

TU (1)