VR Glasses During Induction of Labour for Pain and Anxiety Relieve

Not Applicable

• Conditions: Virtual Reality; Extra Amniotic Balloon; Induction of Labor Affected Fetus / Newborn
• Interventions: Device: Virtual Reality glasses

• Registration Number: NCT05187247
• Lead Sponsor: Wolfson Medical Center

Brief Summary

In the current study, The investigators aim is to test the distraction affect of "Virtual Reality" (VR) technology on pain and anxiety in pregnant women who undergo through an induction of labour with an extra-amniotic balloon catheter

Detailed Description

Insertion of Extra-Amniotic Balloon (EAB) is a recommend mechanical method of Induction of labour. This method of induction causes the cervix to dilate through mechanical pressure on the cervix.

During the procedure of insertion the women is lying on her back. Insertion of EAB is performed by conventional means.

The insertion of EAB can involve discomfort, pain and anxiety before and during the procedure.

While there are numerous studies which describe interventional, pharmacological and non-pharmacological means for pain and anxiety relieve during latent and active phase of labour, there is no sufficient evidence for pain and anxiety relieve during the pre-labour and through induction of labour period.

The "Virtual Reality" (VR) technology is a simple non-invasive technology. The advantage of VR is that it can distract the patient's attention from pain and anxiety by exposure to a virtual reality environment. This technology uses processes of sight, and hearing that requires attention.

Many studies have already investigated the use of VR technology in various medical procedures, such as dental treatment, infusion, pediatric treatment, burns, trauma, chemotherapy, diagnostic hysteroscopies and other medical procedures that are common to the patient's experience of pain and anxiety.

Study Timeline

• Study Start: 2021-11-23
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-24
• Status Verified: 2022-01
• Study First Posted: 2022-01-11
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-27
• Primary Completion: 2022-11-01
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 145

Inclusion Criteria

• Pregnant women going through mechanical induction of labour with Extra-Amniotic Balloon

Exclusion Criteria

• Women with history of migraine, headache, epilepsy, vestibular disorders
• Women suffering from seasickness ,motion sickness, vertigo, nausea, vomiting, seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR group	Virtual Reality glasses	Women assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure

Primary Outcome Measures

Name	Time	Method
Change in pain severity	1 hour	Subjective assessment of the degree of pain would be graded according to the VAS (Visual Analogue Scale) which is a scale used to measure subjective pain intensity according to a pain scale of 0 to 10, An objective pain assessment will be performed by measuring a pulse at a predetermined time points.

Secondary Outcome Measures

Name	Time	Method
Change in Anxiety state	1 hour	Anxiety levels will be measured by a valid questionnaire for assessing situational anxiety called The State-Trait Anxiety Inventory (STAI: Y). This version includes 20 statements which represents feelings that characterize anxiety. Women will be asked to rate them on a scale between 1 to 4. The final score in each questionnaire is obtained by summarizing all the ratings. A higher score indicates a higher level of anxiety.

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 H̱olon, Israel