The current study assessed the feasibility and the potential effects of the body scan as a mindfulness-based intervention integrated in physiotherapy for women with vulvodynia. The primary aim of this study is to investigate whether the mindfulness body scan is a safe and feasible tool in pelvic floor physiotherapy for vulvodynia.
The first objective was to determine the feasibility of conducting a randomized clinical trial designed to compare multimodal pelvic floor therapy with and without mindfulness-based body scan training among patients diagnosed with vulvodynia. 
The secondary objective was to assess the impact on outcome parameters. For this purpose, a pilot study was conducted and evaluated. 
The research question “Do patients diagnosed with vulvodynia benefit more from body scan training in combination with standard multimodal pelvic floor physical therapy than from standard multimodal pelvic floor physical therapy alone in terms of average pain intensity?” was formulated.  This study aimed to determine the protocol and the sample size for a follow-up study.

In this unblinded randomized controlled trial, participants were women diagnosed with vulvodynia who were prescribed physical therapy. Participating patients were randomized to either multimodal physiotherapy or multimodal physiotherapy plus mindfulness-based body scan training. For the control group as well as for the intervention group, 10 therapy sessions of 60 minutes each of standard multimodal pelvic floor physiotherapy were scheduled over a total period of 10 weeks. The intervention group was instructed to perform the 25-minute body scan 5 times a week in addition to physiotherapy. An audio file for practice and a body scan diary for documentation were handed out. The criteria of feasibility were predefined.  

The primary outcome was the average pain intensity assessed with the Numerical Rating Scale (NRS) on the questionnaire "Measuring Pain Intensity". In addition, the following secondary outcomes were collected: 

Current, least, most intense pain intensity over the past 7 were conducted using the Measuring Pain Intensity Questionnaire. Sensory and affective pain quality was assessed using the McGill-Melzack Pain Questionnaire (SF-MPQ). Personal distress, related to sexuality, was assessed using the Female Sexual Distress Scale (FSDS). Sexual function was assessed using the Female Sexual Function Index (FSFI). Pain-related self-efficacy was elicited using Pain Self-Efficacy Questionnaire (PSEQ). 
The intensity of body awareness was measured using the Awareness Body Chart (ABC). Pain-related Catastrophizing was tested with Pain Catastrophizing Scale (PCS). The impression of change due to therapy was assessed with the Patient Global Impression of Change Scale (PGIC).
To determine trends of a fundamental effect, parallel group comparisons of the mean values of the most important parameters were performed. The evaluation was carried out using non-parametric methods, which enabled a comparison of pain reduction and secondary outcomes between the therapy groups. Based on an intention-to-treat analysis, the values obtained were compared over the course of the 3 survey time points. Assessments were made at baseline, post-treatment and at the 2.5 month follow-up.

Thirty-three women with vulvodynia met the inclusion criteria. The groups consisted of following participants: 17 were randomized to the intervention group receiving multimodal pelvic floor physiotherapy and body scan training, while 16 were assigned to the control group receiving multimodal pelvic floor physiotherapy. Of the participants in the intervention group, a total of 15 women completed the body scan training more than 10 times, at a mean of 27.9 times.
The mean of the average pain intensity showed 2.9 (58 %) sustainable reduction from baseline to follow-up in the intervention group in comparison with no change in the control group. 
The following secondary outcomes show distinct differences in comparison of mean values, baseline to follow-up, between the intervention and control group: 
present pain intensity (NRS) –3.5 (70 %) (intervention group): ¬–0.3 (10.4 %) 
(control group); 
least pain intensity (NRS): –2.4 (63.16 %): –0.2 (10.53 %) 
worst pain intensity (NRS) –3.8 (51.36 %): –1 (18.18 %)
Female Sexual Distress Scale (FSDS-Revised): –28.2 (51,7 %): –2.8 (8,95 %) 
Pain Catastrophizing (PCS): –13,1 (56,22 %): –3.3 (17,18 %)
Pain intensity at internal pelvic floor screening (NRS): –3.4 (61,81%): –0.8 (19,51%) 
Sensory pain index (SF-MPQ): –6.6 (50%):  –0.9 (7.9%). 
Affective pain index (SF-MPQ): –1.9 (59.37 %): –0.3 (11.25 %).
Sexual function (FSFI total score): + 6 (16,66 %): + 4.7 (13,05 %). 
Pain-related self-efficacy (PSEQ):  + 8.9 (19.14%): + 4.1 (7.9%). 
Intensity Body Awareness (ABC): +0.28: +0.27, 0.01 difference.
The change due to therapy, measured by PGIC, shows a clear change only in the intervention group. 
The sample size calculation was based on the values of the primary outcome average pain intensity. Recruitment of 99 patients is needed for 0.05 failure probability and variance of 1, drop-out 10 percent in a following trial.

The criteria to judge the feasibility of the body scan, of the protocol and of conducting a trial were met.  
Clear improvements in the group comparison were seen for the outcomes of average pain intensity and sex-related distress.  
Comparing the mean values shows clear reduction of pain in all tested pain-parameters. Mindfulness body scan training seems to be a promising pain and stress reduction strategy in physiotherapy for vulvodynia.
Due to the overall small increase in scores, no improvement in sexual function can be measured with the FSFI. Better results for the intervention group were shown on all tests except intensity of body awareness.

This was the first randomized controlled unblinded pilot study to examine the use of a mindfulness-based body scan intervention integrated in physiotherapy for vulvodynia. The findings suggest that mindfulness-based body scan training is a safe and feasible tool integrated in multimodal pelvic floor physiotherapy. The intervention studied seems to make physiotherapy for vulvodynia more efficient in terms of pain and stress reduction. A larger double-blind randomized controlled trial should confirm the promising findings of this pilot study.

Continence 2S2 (2022) 100449
DOI: 10.1016/j.cont.2022.100449