VR Scenario for Labor Pain Control

NCT05879848 | Completed

• 1 other identifier: FEDIIU485/20
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate Virtual Reality analgesic interventions for active labor with biofeedback-based Virtual Reality technologies synchronized to uterine activity. The investigators developed a Virtual Reality system modeled on uterine contractions by connection to a cardiotocographic equipment. The present study, based on a multidisciplinary approach, comprised the following phases: 1)development of hardware and software components; 2) design of the Reality scenario through a qualitative focus group discussion study; 3) clinical trial on a sample of 53 cases and 53 controls during active labor.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• Subjective pain

  numerical rating scale for pain

  1 year

Secondary Outcomes (6)

• NAUSEA

  1 year

• Objective pain via wristband

  1 year

• incidence of episiotomy and lacerations

  1 year

• epidural anesthesia

  1 year

• incidence of operative delivery

  1 year

Study Arms (2)

Experimental analgesic treatment (VR)

EXPERIMENTAL

Achieved active labor and regular contractions (\>= 4 contractions in 10 minutes), patients are given the virtual reality scenario synchronized with the uterine contractions , and no other alternative analgesia is provided, except for the midwife's support.

Other: VR

Standard Care (non-VR)

NO INTERVENTION

Patients in active labour. undergo standard care (only midwife's support, no analgesia)

Interventions

VR OTHER

virtual reality scenario synchronized with the uterine contractions

Experimental analgesic treatment (VR)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Single term pregnancy;
• Full term physiological pregnancy;
• Active phase of labor;
• Spontaneous labor;
• Nulliparous between 37 and 42 weeks of gestation with cephalic presentation;
• Maternal age between 18 and 45 years.

You may not qualify if:

• Twin pregnancy;
• Preterm labor;
• Preterm rupture of amnio membranes;
• Fetal abnormalities;
• Intrauterine growth restriction;
• Post-term pregnancy;
• Women with impaired consciousness, seriously ill, mentally disabled;
• Women under the age of 18 or over the age of 45;
• Women with visual and/or auditory impairments;
• Women prone to seizures;
• Women with a predisposition to motion sickness;
• Refusal to sign informed consent;
• Previous cesarean section.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: May 30, 2023
• Study Start: November 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)