This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.
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Adherence rate
Timeframe: 2-week post-treatment evaluation
Level of satisfaction with the treatment
Timeframe: 2-week post-treatment evaluation
Willingness to recommend the treatment
Timeframe: 2-week post-treatment evaluation
Rate of adverse events
Timeframe: 2-week post-treatment evaluation
Blinding effectiveness
Timeframe: 2-week post-treatment evaluation
Recruitment rate
Timeframe: Baseline to 2-week post-treatment evaluation
Completion and dropout rates
Timeframe: 2-week post-treatment evaluation
Completeness of data
Timeframe: Baseline to 2-week post-treatment evaluation