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

NCT ID: NCT05571358

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain Pelvic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

Following clinical practice guidelines, subjects in the control group will receive multidisciplinary rehabilitation programmes with coordinated delivery of supervised exercise therapy, cognitive behavioural therapy (education on pain), as well as therapeutic massage to relieve low back pain during pregnancy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Virtual Reality (Nature Trek)

* Subjects in the experimental group will receive the same treatment described for the control group.
* Subjects in the experimental group will receive an additional Virtual Reality Intervention (VRi).

Group Type EXPERIMENTAL

Virtual Reality (Nature Trek)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult woman over 18 years old
* Pregnant woman with Low Back Pain, Pelvic Pain (PP) or both conditions with symptomatic character.
* Pregnant woman between the 12th and 36th week of gestation, corresponding to the 2nd and 3rd trimester.
* Pain intensity greater than 4/10 on VAS, indicating moderate-severe pain.
* Live in Sevilla or Malaga during the research period.

Exclusion Criteria

* Patients with LBP or PP pain prior to pregnancy.
* Cognitive ability not suitable for the use of technological tools.
* Patients with absolute or relative contraindications.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Francisco Jose García Lopez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Francisco José García López, Physiotherapy

Role: CONTACT

[email protected]
695332991

References

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Garcia-Lopez FJ, Pastora-Bernal JM, Moreno-Morales N, Estebanez-Perez MJ, Linan-Gonzalez A, Martin-Valero R. Virtual reality to improve low-back pain and pelvic pain during pregnancy: a pilot RCT for a multicenter randomized controlled trial. Front Med (Lausanne). 2023 Sep 4;10:1206799. doi: 10.3389/fmed.2023.1206799. eCollection 2023.

Reference Type DERIVED
PMID: 37731709 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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VR - LBP

Identifier Type: -

Identifier Source: org_study_id