چکیده (انگلیسی):

Background:Sexual dysfunction is prevalent in patients with type 2 diabetes mellitus, but remains one of the most
frequently neglected complications in diabetes care. Both patients and care providers appear to have difficulty with
discussing sexual problems in diabetescare. A sexual counselling model for care providers, such as the PLISSIT model,
might be a useful tool to improve the discussion of sexual issues in patients with type 2 diabetes mellitus. PLISSIT stands
for Permission, Limited Information, Specific Suggestions, and Intensive Therapy. Even though the use of the
PLISSIT model has often been recommended in diabetes care, no evidence with regards to its effectiveness in
patients with type 2 diabetes mellitus exists. This studydescribes the design of a cluster-randomised controlled
trial evaluating the effectiveness of a PLISSIT-model intervention in men and women with type 2 diabetes mellitus in
primary care.
Methods/Design:Patients with type 2 diabetes mellitus, aged 40–75 years, who indicate to be dissatisfied about their
sexual functioning and that they would like to talk about their sexual problem(s) with their general practitioner are
recruited. All participants receive an information leaflet from the practice nurse. In the intervention group, each participant
will also receive sexual counselling based on the PLISSIT modelfrom their general practitioner. In the control group, usual
care will be provided to those participants requesting an appointment withtheir general practitioner when the
information leaflet was not deemed sufficient. Primary outcomes include sexual functioning, satisfaction about
sexual function, and quality of life. Secondary outcomes are depressive symptoms, sexual distress, emotional well-being,
and treatment satisfaction. Outcomes will be measured by means of self-report questionnaires at baseline, and after 3 and
12 months post-baseline. Treatment satisfaction will be assessed in telephone interviews.
Discussion:This paper describes the design of a cluster-randomised controlled trial that will investigate the effectiveness
of a PLISSIT-model intervention in patients with type 2 diabetes mellitus in primary care. Our study will add important
and currently missing insight into the effectiveness of PLISSIT on important patient-reported outcomes of men and
womenwithtype2diabetesmellitus.
Trial registration:Dutch Trial Registry NTR4807.