Participants
Sex, intimacy and sexual pain remain private topics which may result in a reluctance to participate. In an attempt to overcome this barrier, healthcare professionals (HCP) working in the field of sexual health will be recruited to invite their patients to participate in the study, which introduces omission bias, as potential participants in the public sector are likely to be excluded. Purposive sampling [45, 46] with snowballing will be used in an attempt to overcome the omission bias. All women who meet the inclusion criteria will be included. The estimated number of patients seen per annum by healthcare professionals consulted prior to commencing the study indicated a population size of 200 women. In order for the survey results to be statistically valid a minimum of 132 completed questionnaires are required. The margin of error was set at 5% and the confidence level at 95%. With an estimated response rate of 25% for online surveys, a total of 528 participants would have to be invited to achieve the required sample size. Inclusion criteria are (i) females from the age of 18 and (ii) a diagnosis of GPPPD. Exclusion criteria are (i) previous treatment for SPD; (ii) diagnosis affecting the neurological system e.g., Multiple Sclerosis; (iii) cancer-related diagnosis; and (iv) pregnant at time of completing questionnaire.
Research Instruments
Sensory processing
Sensory processing patterns will be measured by 163 items on the Adolescent/Adult Sensory History (ASH) questionnaire [47]. Reliability of the ASH’s total score is 0.85 and concurrent validity 0.78 (p<.001) [47–49]. The ASH is relatively new, but has already been used in a few studies [50, 51]. This self-report questionnaire identifies dysfunction in five key areas, namely sensory discrimination, sensory modulation, postural ocular skills, praxis/motor coordination, and social-emotional functioning, [47] as well as functional problems related to each of these areas. Additionally, it describes overall sensory processing which is also divided into sub-sections based on sensory modalities (e.g., touch and taste). It uses a five-point Likert-type scale and can be used by individuals aged 13 to 95 years. The questionnaire takes 15 to 20 minutes to complete.
The ASH provides a total score, reflecting the functioning in overall sensory processing. This is followed by sub-scores for the sensory section, sensory modulation, sensory discrimination, functional problems and motor/social sections respectively. Each sub-score also consists of separate modalities which identify problems in specific areas.
While the original instrument allows for a small number of questions not to be completed, the online questionnaire will only proceed to the next section if all items have been completed, thus attempting to minimise incomplete questionnaires which cannot be included for analysis.
Anxiety
Levels of anxiety will be assessed by the Hospital Anxiety and Depression Scale’s (HADS) scales for Anxiety (HADS-A). This self-administered subscale consists of seven questions for anxiety, with a four-point (0 to 3) ordinal response format. The instrument takes between two to five minutes to complete. The HADS-A has a correlation score of 0.80 and the validity has been described as good to very good [52]. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety has a specificity of 0.78 and a sensitivity of 0.9, and for depression a specificity of 0.79 and a sensitivity of 0.83 [53, 54].
Cut-off scores existed for the following diagnostic categories: normal (score 0 to 7), borderline (8 to 10) and clinical/abnormal (score 11 to 21).
Procedure/Data collection
Potential participants will receive an e-mail from the HCP containing information regarding SPD and a link to a secure online questionnaire on the Research electronic data capture (REDCap) platform. Participation in both phases will be completely voluntary and participants can withdraw from the study without any detriment at any time. Informed consent will be obtained electronically, prior to completing the demographic information (age, gender, additional diagnosis, highest qualification, marital status, number of children & age, sexual history, province) and online questionnaires (ASH & HADS). Data can be submitted anonymously, or an e-mail address can be provided should participants wish to be considered for phase two of the study. Each online questionnaire will receive a unique identification number. All identifying data (including consent regarding participation in phase two and e-mail addresses) will be kept securely, separate from the questionnaires. Once a questionnaire has been scored and SPD identified, the questionnaire number will be compared to the list of participants who gave consent to be contacted regarding participation in phase two.
Ethical clearance has been obtained from the Human Ethics Research Committee at the University of the Witwatersrand (Certificate Number M170829).
Data Analysis
Responses to the questions will be assigned a numeric value within REDCap software. The raw data for each participant will be exported from REDCap to Excel.
The responses to the ASH will be entered into the AASH-Scoring Program©, which generates individual reports providing raw scores, z-scores and interpretation of scores. Standardised scores will be divided into three categories (nominal variables), namely “typical performance”, “mild difficulties” (frequently demonstrates functional difficulties in some areas of sensory, motor or social/emotional processing) and “definite difficulties” (performance is well outside typical performance and almost always results in functional difficulties). Clinically, a diagnosis of “mild difficulty” requires further investigation or assessment whereas a diagnosis of “definite difficulty” requires intervention. For analysis purposes, the “mild difficulty” and “definite difficulty” categories will be combined, to indicate the percentage of participants who fall outside the parameters of typical functioning.
The responses to the HADS-A will be exported to Excel and scored according to its categories, namely normal, borderline and clinical/abnormal.
Results obtained on the ASH and HADS-A (only anxiety items will be computed as the presence of depression is beyond the scope of the current study) will be transferred to Excel for each participant and then to an Excel summary sheet for each instrument. The cleaned data will be imported into Statistica analytics software program.
Descriptive statistics will be used to analyse data. Ordinal data obtained via the demographic questionnaire, specifically age and sexual history will be analysed using measurement of central tendency, specifically the mean and median, as well as measurement of dispersion of the data, specifically the standard deviation and range.
Categorical data obtained via the ASH and HADS-A will be analysed using frequencies and percentages.