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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01659359
Other study ID # virtual reality glasses
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 4, 2012
Last updated August 7, 2012
Start date January 2011
Est. completion date August 2012

Study information

Verified date August 2012
Source Mashhad University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

In recent studies using virtual reality has been proposed as a non pharmacological methods for pain relief but until this time , its effects has not been assessed on pain and anxiety during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain and anxiety in Primiparity women during episiotomy repair.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 34 Years
Eligibility Inclusion Criteria:

- Iranian

- low risk pregnancy

- Apgar = 7

Exclusion Criteria:

- vision or ear disorders

- History of motion sickness or headaches

- psychological disease or Addiction

- Prescribe narcotic or sedation 4hour prior to delivery.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Virtual reality glasses and Lidocaine
The samples were randomly allocated to use Virtual reality glasses and 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.
Drug:
Lidocaine
The samples were randomly allocated to use 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mashhad University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Virtual reality glasses decreased pain and anxiety during episiotomy up to 8 months Yes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06417047 - Effect of Hand Holding on Pain and Anxiety N/A
Not yet recruiting NCT06425835 - Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments