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

Yi-Ling Wang, Hai-Xiang Gao, Jin-She Wang, Jing-Hui Wang, Lei Bo, Ting-Ting Zhang, Ya-Liang Dai, Lu-Lu Gao, Qiang Liu, Jun-Jun Zhang, Ju-Min Cai, Jian-Qiang Yu, Yu-Xiang Li, Yi-Ling Wang, Hai-Xiang Gao, Jin-She Wang, Jing-Hui Wang, Lei Bo, Ting-Ting Zhang, Ya-Liang Dai, Lu-Lu Gao, Qiang Liu, Jun-Jun Zhang, Ju-Min Cai, Jian-Qiang Yu, Yu-Xiang Li

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.

Keywords: Analgesia; Hysterosalpingography; Pilot study; Virtual reality.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design framework. BC blank control, BP blood pressure, GRS graphic rating scale, HSG hysterosalpingography, P pulse, SpO2 oxygen saturation, VAS visual analog scale, VR virtual reality
Fig. 2
Fig. 2
SPIRIT schedule of enrolment, interventions, and assessments. BP blood pressure, GRS graphic rating scale, HSG hysterosalpingography, P pulse, SpO2 oxygen saturation, T0 baseline, T1 immediately after HSG, T2 15 min after HSG, VAS visual analog scale
Fig. 3
Fig. 3
Screenshots of the virtual scenes provided for participants in the virtual reality group. a The land of magma. b The frozen ground. c A flowering tree in the violet world
Fig. 4
Fig. 4
A patient undergoing a hysterosalpingography procedure on the fluoroscopic table ‘enters’ the immersive virtual world

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