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.
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Details
1 Ningxia Medical University, School of Nursing, Yinchuan, China (GRID:grid.412194.b) (ISNI:0000 0004 1761 9803); The First People’s Hospital of Yinchuan, Nursing Department, Yinchuan, China (GRID:grid.477991.5)
2 Ningxia Medical University, School of Nursing, Yinchuan, China (GRID:grid.412194.b) (ISNI:0000 0004 1761 9803)
3 Ningxia Medical University, School of Science, Yinchuan, China (GRID:grid.412194.b) (ISNI:0000 0004 1761 9803)
4 Yinchuan Women and Children Healthcare Hospital, Radiology Department, Yinchuan, China (GRID:grid.412194.b)
5 Ningxia Medical University, Foreign Language Teaching Department, Yinchuan, China (GRID:grid.412194.b) (ISNI:0000 0004 1761 9803)
6 The First People’s Hospital of Yinchuan, Nursing Department, Yinchuan, China (GRID:grid.477991.5)
7 Ningxia Medical University, School of Public Health and Management, Yinchuan, China (GRID:grid.412194.b) (ISNI:0000 0004 1761 9803)
8 Ningxia Medical University, School of Preclinical Medical Sciences, Yinchuan, China (GRID:grid.412194.b) (ISNI:0000 0004 1761 9803)
9 Pharmaceutical Institute of Ningxia Medical University, Department of Pharmacology, Yinchuan, China (GRID:grid.412194.b) (ISNI:0000 0004 1761 9803)