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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
Centre hospitalier Universitaire de Sherbroke
Sherbrooke, Quebec, Canada
Adherence rate
To determine acceptability by assessing adherence to treatment sessions
Time frame: 2-week post-treatment evaluation
Level of satisfaction with the treatment
To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied)
Time frame: 2-week post-treatment evaluation
Willingness to recommend the treatment
To determine acceptability by assessing whether the participant would recommend the treatment.
Time frame: 2-week post-treatment evaluation
Rate of adverse events
To document any adverse events.
Time frame: 2-week post-treatment evaluation
Blinding effectiveness
To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists. Evaluated by asking the question: ''What treatment do you think you have received / given? ''
Time frame: 2-week post-treatment evaluation
Recruitment rate
To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
Time frame: Baseline to 2-week post-treatment evaluation
Completion and dropout rates
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
Time frame: 2-week post-treatment evaluation
Completeness of data
To examine the percentage of completed outcome measures.
Time frame: Baseline to 2-week post-treatment evaluation
Change in pain intensity during intercourse
To explore changes in pain intensity during intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
Time frame: Baseline to 2-week post-treatment evaluation
Change in sexual function
To explore changes in sexual function (Female Sexual Function Index). Minimum value: 2, Maximum value: 36 and lower scores mean worst outcome (low sexual function).
Time frame: Baseline to 2-week post-treatment evaluation
Change in sexual distress
To explore changes in sexual distress (Female Sexual Distress Scale ). Minimum value: 0, Maximum value: 52, higher scores mean worst outcome (higher sexually related distress).
Time frame: Baseline to 2-week post-treatment evaluation
Change in pain quality
To explore changes on the sensory, affective and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores mean worst outcome (higher pain).
Time frame: Baseline to 2-week post-treatment evaluation
Patient's global impression of change
To examine patient self-reported improvement (Patient's Global Impression of Change ranging from "very much worse" to "very much improved" on a 7-point scale.
Time frame: Baseline to 2-week post-treatment evaluation
Change in fear of pain
To explore changes in fear of pain (Pain Anxiety Symptoms Scale (PASS-20)). Minimum value: 0, Maximum value: 100, higher scores mean worst outcome (higher fear of pain).
Time frame: Baseline to 2-week post-treatment evaluation
Change in pain catastrophization
To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization)
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Time frame: Baseline to 2-week post-treatment evaluation
Change in vulvar pain sensitivity
To explore changes in vulvar pain sensitivity (algometer)
Time frame: Baseline to 2-week post-treatment evaluation
Change in vulvar blood circulation
To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs).
Time frame: Baseline to 2-week post-treatment evaluation