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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Obstetric Labor
• Intervention / Treatment: Other: Digital vaginal examination; Device: Transperineal ultrasound examination

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erkan Kalafat, MD; Phone Number: 05334736998; Email: ekalafat@ankara.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Digital vaginal examination; Patients assigned to this group will be followed-up with digital vaginal examinations as described in intervention protocol.	Other: Digital 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.
EXPERIMENTAL: Transperineal ultrasound examination; Patients assigned to this group will be followed-up with transperineal ultrasound examinations as described in intervention protocol.	Device: Transperineal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Principal Investigator: Erkan Kalafat, MD, Ankara University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ANTICIPATED): March 1, 2016
• Study Completion (ANTICIPATED): March 1, 2016

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (ESTIMATE): November 6, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 14, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: labor, vaginal examination, transperineal ultrasound, pain, anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 006