Study design
This research was a quasi-experimental study with pretest-posttest and follow-up design with control group.
Setting
The target population consisted of women with MS referring to MS Society of Qom province between 2018 and 2019. Qom is the seventh largest metropolis of Iran and is located 140 km to the south of Tehran with estimated 1,201,158 populations.
This research was conducted in MS Society of Qom. Multiple Sclerosis Society of Iran (MS Association of Iran) is a non-political, non-commercial, non-profit and charitable organization. The Association provides medical, educational, and welfare services to these patients with a population over 1310 patients.
2.3. Sample size
The sample size was calculated using Cochran formula considering 95% and 80% power coefficients, and the variance (14), accordingly 22 couples were placed in each group.
Patients
The patients were invited to participate in the study through written posters on social networks including telegram and Instagram pages of MS society of Qom city. 44 cases (out of 65 volunteers) who met the inclusion criteria signed the written consent forms after getting aware of the study's goals and ethical considerations. Inclusion criteria included age over 18 years old, being married with at least two years of marital life, diagnosed as MS patient according to McDonald's criteria by a neurologist, having a history of treatment for at least six months, absence of any severe marital discord and court cases, no drug addiction, absence of any recent life crises other than multiple sclerosis, and absence of any psychiatric disorder .The exclusion criteria were Absence of one spouse for more than one session, unwillingness to continue the project, recurrence of the illness, and the concurrent presence in another study. In this study, 65 subjects volunteered to participate in the study, of whom 44 cases met the criteria.
The MS patients and their spouses (44 couples were randomly divided into two groups. The assigned block "A" or "B" was determined based on the letter "A" or "B" hidden in 44 sealed and unmarked envelopes. The assigned group was identified when each participant opened her picked envelope. Finally, 20 couples in the intervention group and 21 couples in the control group were reminded for the analysis (Fig. 1).
Study tools
The participants were assessed by the questionnaire of demographic characteristics (including age, sex, education, spouse age, spouse illness, number of children, duration of illness, and any other illness), and 54-item MS Quality of Life Questionnaire (MSQOL-54). MSQOL-54 was designed by Vickrey (1995) via adding 18 items to the short-form quality of life questionnaire (SF36). Minimum and maximum score is between 0-100, in that higher score indicates higher quality of life (QLI).
The general dimensions included physical health and psychological health. The subscales of physical health were: physical function (10 items scoring with a 3-option Likert scale), role limitations due to physical problems (4 items scoring as yes = 1, no = 2), health perceptions (5 items scoring with a 5-option Likert scale), energy/fatigue (5 items scoring with a 6-option Likert scale), pain (3 items scoring with a 6-option Likert scale), sexual function (4 items scoring with a 4-option Likert scale), and social function (3 items scoring with a 5-option Likert scale).
psychological dimension subscales included: health distress (4 items scoring with a 6-option Likert scale), emotional well-being (5 items scoring with a 6-option Likert scale), role limitations- emotional (3 items scoring as yes = 1, no = 2), cognitive function (4 items scoring with a 6-option Likert scale).
Finally, 4 items in overall health change (1 item in 0-100), overall sexual satisfaction (1 item from 0-100), and overall quality of life (2 items in 1–7) and structural validity were confirmed using factor analysis. The Cronbach's alpha coefficient of 0.82 was reported for this questionnaire (15).
Methods of study
Intervention Skill-based Sexual Enhancement Counseling Program (SSE-CP) of couples was performed in six 90-minute sessions in MS Association. The SSEP protocol was administered for couple counseling in the presence of the couples who were blind of the presence of other couples in the research group. SSE-CP meeting protocol was designed based on similar interventions extracted from textbooks and articles (16, 17).
The designed protocol was reviewed and confirmed by experts including a clinical psychologist, a sexologist, family counselors, and neurologists. The experts' recommendations regarding sexual difficulties and needs of MS patients were included in the protocol. The couple therapy sessions of SSE-CP were held in MS Association of Qom city twice a week, each for 90 minutes. One of researchers as a counselor was trained a 3-month course of SSE-CP. In the first session, the participants were explained about goals, expectations and procedure of the study. Couples who were willing to participate in the project and met the criteria signed the consent forms and completed the questionnaires including demographic characteristics, (MSQOL-54). The sessions were administered face to face with each couple under supervision of a fertility health PhD professional for six 90-minute sessions twice a week. The participants were assessed by (MSQOL-54) at the end of the sixth session. They were asked to use the skills they were trained in daily life and contact with researcher after 12 weeks in the same place to complete (MSQOL-54). The content of sessions was as following:
The contents of the skill–based sexual enhancement counseling sessions were as follows:
Session 1: building rapport, reviewing the complications caused by MS on marital and sexual relationships, and presenting the sexual response pattern and its changes in Multiple Sclerosis. The assigned homework was reading booklet of sexual functions and sexual positions in MS patients.
Session 2: problem- and conflict-solving methods and skills to make personal changes (for both the participants). Checking the homework assigned in the previous session.
Session 3: training empathy skills, self-emotional expression skill, displaying a video clip for enhancement emotional–sexual expression; homework: talk about a sexual or marital problem and explain if they could solve it, how they solved it, and how they dealt with it (by using the learned skills
Session 4: reviewing the content and the homework of the previous session. Training negotiation skill.
Session 5: training effective spouse communication skills by displaying video clip.
Session 6: providing counseling for specific sexual problems in Multiple Sclerosis patients.
The obtained data were analyzed using SPSS-20 software. Mean and standard deviation were used to describe the descriptive analysis, and the independent t-test, ANOVA repeated measurement, T-test, Friedman and Chi-square tests were used for analytical analysis.