NCT05571358

Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy

Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy for a Multicentre Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: University of Malaga · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A large percentage of women suffer low back and pelvic pain both during and after pregnancy. There are several factors to which these complaints are attributed, even affecting their daily lives. It is identified that many of these women do not receive adequate health care, however, different physiotherapeutic interventions are recommended to alleviate these conditions, presenting moderate levels of evidence. Virtual reality (VR) is presented as a complementary and promising treatment method to physiotherapy for the improvement of fundamental variables such as perceived pain and pain avoidance. The main objective is to evaluate the efficacy of a combined VR and physiotherapy program of 4 weeks duration compared to a standard physiotherapy intervention in pregnant women with low back pain and pelvic pain for the improvement of pain avoidance, pain intensity, disability and functional level. As a secondary objective the investigators propose to investigate patient satisfaction with the VR intervention. This research will be carried out by means of a multicenter randomized controlled clinical trial in pregnant patients residing in the provinces of Seville and Malaga with a diagnosis of low back pain and pelvic pain during pregnancy. The alternative hypothesis of this research is that the implementation of a Virtual Reality program together with standard physiotherapy in pregnant patients with low back and pelvic pain presents better clinical results obtained with the current standard intervention, which may represent an opportunity to define new policies and interventions for these pathologies and their consequences.

Conditions

• Low Back Pain
• Pelvic Pain

Interventions

Type	Name	Description
DEVICE	Virtual Reality (Nature Trek)	At the end of each session, participants will experience an immersive virtual landscape displayed by Nature Trek VR software (httpp://naturetreksvr.com/). First, participants will be placed in a sit down position and guided for their breathing control during 5 minutes ("meditation Lotus option"). After that, they will be encouraged to freely move around a relaxing virtual environment during 15 minutes taking special attention to soothing sounds of nature. The themes environment will be selected based on the preferences of the participants. At the beginning of the study, advice is given on general care, in physical activity and issues concerning drug intake. Patients are advised to refrain from any other specific training during the intervention period. Any deviations from the adherence and practice of the VRi are recorded daily, noting any adverse incidents.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-07-01
• Completion: 2024-12-01
• First posted: 2022-10-07
• Last updated: 2023-11-29