Immersive virtual reality as analgesia for women during hysterosalpingography: study protocol for a randomized controlled trial.

Abstract:

BACKGROUND:Hysterosalpingography (HSG) is an accepted radiologic diagnostic modality for initial infertility workup, and is generally considered uncomfortable and painful. However, the management of pain related to HSG remains inefficient. As an emerging nonpharmacologic and noninvasive pain control strategy, virtual reality (VR) distraction has been successfully used in areas such as burns, blunt force trauma, hospital-based needle procedures, dental/periodontal procedures, and urological endoscopy patients. This study aims to evaluate the analgesic effect of VR during HSG. METHODS/DESIGN:A single-center, parallel-group, randomized controlled trial will be carried out in the Radiology Department of Yinchuan Women and Children Healthcare Hospital, Yinchuan. A total of 200 participants who are scheduled for HSG will be enrolled in this study. The participants will be randomized (1:1) into two groups: a VR group and a blank control group. The VR group will receive routine care plus immersive VR intervention and the blank control group will receive routine care. Outcomes will be monitored at baseline, immediately after HSG and 15 min after HSG for each group. The primary outcome is the worst pain score during HSG by a visual analog scale (VAS). The secondary outcomes include: affective pain, cognitive pain, and anxiety during the HSG procedure; worst pain within 15 min after HSG; patient satisfaction and acceptance with pain management; physiological parameters; adverse effects; HSG results; and immersion perception score of the VR system (for the VR condition only). DISCUSSION:This study will focus on exploring a simply operated, noninvasive and low-cost analgesia during the HSG procedure. The results of this trial will provide data on the feasibility and safety of VR distraction therapy during HSG. TRIAL REGISTRATION:Chinese Clinical Trial Register, ChiCTR1900021342. Registered on 16 February 2019.

journal_name

Trials

journal_title

Trials

authors

Wang YL,Gao HX,Wang JS,Wang JH,Bo L,Zhang TT,Dai YL,Gao LL,Liu Q,Zhang JJ,Cai JM,Yu JQ,Li YX

doi

10.1186/s13063-019-4023-y

subject

Has Abstract

pub_date

2020-01-20 00:00:00

pages

102

issue

1

issn

1745-6215

pii

10.1186/s13063-019-4023-y

journal_volume

21

pub_type

杂志文章,随机对照试验

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