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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02599610
• Other study ID #: 006
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2015
• Last updated: February 14, 2016
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Ankara University
• Contact: Erkan Kalafat, MD
• Phone: 05334736998
• Email: ekalafat[@]ankara.edu.tr
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Obstetric Labor
• Pregnancy

Intervention

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.

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.

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No