NCT05941390

Brief Summary

A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will. After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology. Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 5, 2023

Last Update Submit

August 2, 2023

Conditions

Virtual RealityAnxietyPain

Outcome Measures

Primary Outcomes (1)

  • stress cortisol saliva level

    each arm after the procedure will be mesured stress cortisol level in saliva

    up to 5 minutes after the procedure

Secondary Outcomes (2)

  • pain levels

    up to 5 minutes after

  • anxiety levels

    up to 5 minutes after

Study Arms (3)

control

NO INTERVENTION

patients undergoing one of the procedures without using VR device

VR without sound

ACTIVE COMPARATOR

patients undergoing one of the procedures using VR device without sound

Device: VR without positive psychology

VR with sound

ACTIVE COMPARATOR

patients undergoing one of the procedures using VR device with sound

Device: VR with positive psychology

Interventions

VR without positive psychologyDEVICE

Using VR goggles showing relaxing short videos without sound

VR without sound
VR with positive psychologyDEVICE

Using VR goggles showing relaxing short videos with positive psychological messages

VR with sound

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
  • amniocintesis -single tone,gestional age 16-24 week,
  • hysteroscopy-women age 18-60 , diagnostic procedure,

You may not qualify if:

  • ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
  • amniocintesis- Known fetal malformations, amnionitis
  • hysteroscopy-pregnancy, PID

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Koyyalamudi V, Sidhu G, Cornett EM, Nguyen V, Labrie-Brown C, Fox CJ, Kaye AD. New Labor Pain Treatment Options. Curr Pain Headache Rep. 2016 Feb;20(2):11. doi: 10.1007/s11916-016-0543-2.

    PMID: 26780039BACKGROUND

  • Woolf CJ. What is this thing called pain? J Clin Invest. 2010 Nov;120(11):3742-4. doi: 10.1172/JCI45178. Epub 2010 Nov 1.

    PMID: 21041955BACKGROUND

  • Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.

    PMID: 31094789BACKGROUND

  • Wong MS, Spiegel BMR, Gregory KD. Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial. Am J Perinatol. 2021 Aug;38(S 01):e167-e172. doi: 10.1055/s-0040-1708851. Epub 2020 Jun 2.

    PMID: 32485759BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Noa glick fishman, MD

    Assuta Ashdod

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noa glick fishman, MD

CONTACT

0544443952noagl@assuta.co.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2023

First Posted

July 12, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

August 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share