NCT07013227

Brief Summary

One of the non-pharmacological methods used to reduce labor pain in multiparous pregnant women is the application of virtual reality glasses. This study aims to measure labor pain and determine the effect of virtual reality glasses application on comfort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

June 2, 2025

Last Update Submit

June 2, 2025

Conditions

Keywords

birthlabor painvirtual reality glasses

Outcome Measures

Primary Outcomes (1)

  • birth comfort scale

    40 weeks

Study Arms (2)

control group

NO INTERVENTION

It refers to the group in which virtual reality glasses will not be applied.

experimental group

EXPERIMENTAL

It refers to the group to which virtual reality glasses will be applied.

Other: experimental group

Interventions

Labor pain and comfort level will be measured by applying virtual reality glasses to the control group.

experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those between the ages of 18-35
  • At least primary school graduate
  • Able to speak and understand Turkish
  • weeks of pregnancy (term)
  • Having a singleton pregnancy
  • Fetal presentation is head
  • Vaginal birth planned
  • Multiparity (2 or more births)
  • Does not have any risks related to pregnancy and birth
  • There is no problem in the fetus
  • In the active phase of labor
  • Pregnant women who volunteer to participate in the study and approve the consent document will be included.

You may not qualify if:

  • Those under the age of 18 (Adolescents)
  • Primiparity (First to give birth)
  • Those who are planned to have a caesarean section
  • Analgesics administered at birth
  • Those who did not want to participate in the study or participated in the study voluntarily but later those who give up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • zümrüt bilgin

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

August 1, 2023

Primary Completion

May 15, 2025

Study Completion

May 20, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations