Design
This is a randomized controlled trial with a control group and an intervention group and a randomization ratio of 1:1. It will compare the effects of SHM-based SE and routine SE on sexual functioning among women living in the suburbs. Both groups will receive SE for three weeks and outcome assessment will be performed before and twelve weeks after the intervention. This trial will be conducted based on the CONSORT guidelines (Fig. 1) [25]. The present protocol has been organized based on the “Standard Protocol Items: Recommendations for Interventional Trials” (SPIRIT) checklist [26].
Participants’ flow in the study
Date of the study
The first participant will be recruited in September, 2024.
Study population
Study population consists of all 15–49-year-old women who live in the suburbs of Zabol, Iran.
Study setting
The setting of the study will be four healthcare centers in the suburbs of Zabol, Iran, where women attend to receive healthcare services.
Participants
Participants will be 15–49-year-old married women who live in the suburbs of Zabol, Iran, and meet the eligibility criteria.
Eligibility criteria
The first author of the study will assess the medical records of participants for eligibility. Eligibility criteria are as follows:
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1.
Age of 15–49 years;
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2.
Matrimony;
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3.
Ability to read and write in Persian;
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4.
Affliction by sexual dysfunction (i.e., a score of less than 28 for the Female Sexual Function Index (FSFI) [27];
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5.
No pregnancy and breastfeeding;
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6.
Residence in the suburbs;
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7.
No affliction by known physical health problems;
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No affliction by severe depression, anxiety, and stress (determined by scores less than 13, 9, and 18 respectively for the depression, anxiety, and stress subscales of the 21-item Depression Anxiety Stress Scale (DASS-21) [28].
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9.
History of sexual activity in the past one month;
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No self-report history of husband’s affliction by sexual dysfunction;
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No intake of any medication for sexual dysfunction;
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12.
No substance abuse; and
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13.
No self-report history of participation in any educational course on marital problems and sexual dysfunction.
Exclusion criteria
Exclusion criteria are as follows:
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1.
No willingness to stay in the study;
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2.
Pregnancy during the study;
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3.
Divorce or husband’s death during the study; and
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4.
Significant life events (such as significant losses) during the study.
Sampling method
Sampling will be started after registering the study in the Iranian Registry of Clinical Trials, obtaining approval from the Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran, and obtaining the necessary permissions from the Faculty of Nursing and Midwifery of this university. As Zabol has ten suburban areas, four areas will randomly be selected and eligible women will be selected from these centers. The aim and the methods of the study will be explained to them and their informed consent will be obtained. They will be asked to complete the study instruments and those with severe depression, anxiety, or stress and those with normal sexual functioning will be omitted. The selected participants will be allocated to two groups through block randomization. Participants in the intervention group will receive SHM-based SE and their counterparts in the control group will receive routine SE in three weeks. All of them will complete the study instruments before and twelve weeks after the intervention. Table 1 shows the schedule of enrolment, intervention, and assessment.
Sample size calculation
Using the free G*Power software (v. 3.1.9.2) (available at www.gpower.hhu.de), sample size was calculated to be 38 per group—76 in total. Parameters for sample size calculation were a mean of 27.19 ± 5.56 for FSFI in the control group at the end of the study [29], a Cohen’s effect size of 0.40, a significance level of less than 0.05, a statistical power of 90% to detect a between-group different of 5 FSFI scores at the end of the study [30], and an overall attrition rate of 10%.
Randomization and allocation
Participants will be allocated to an intervention and a control group through block randomization. All six possible placements of the A and the B letters in four-sized blocks (i.e., AABB, ABAB, BBAA, BABA, ABBA, and BAAB) will be considered and the blocks will be numbered 1–6. As the sample size is 76, the total number of the blocks will be nineteen. Then, a table of random numbers from 1 to 6 (based on the possible placement of the A and the B letters in four-sized blocks) will be generated and the blocks will be arranged according to the table. Consequently, each participant will have a unique code at the time of recruitment and allocation.
Allocation concealment and blinding
For allocation concealment, a colleague external to the study will write the generated allocation sequence on pieces of paper, place the paper pieces in opaque envelopes, and sequentially number the envelopes. The numbered envelopes will respectively be opened and the intended participants will be allocated to the groups. The blinding of researchers and participants in this study is impossible due to the characteristics of the intervention. Yet, outcome evaluator will be blinded through employing a colleague for data collection.
Outcomes
The primary outcome of the study is sexual functioning and its six dimensions, namely desire, arousal, lubrication, orgasm, pain, and satisfaction which will be measured through FSFI. The secondary outcome of the study will be participants’ sexual QOL which will be measured through the Sexual Quality of life-Female questionnaire.
Study instruments
The four study instruments are explained in what follows.
A questionnaire will be used to collect data on participants’ demographic and midwifery characteristic. Its items are on the age, educational level, and occupation of participants and their spouses as well as participants’ income, age at marriage, duration of marital life, number of coituses per month, number of pregnancies, contraception method, history of preterm delivery, and history of having a low-birth-weight child. The validity of this questionnaire will be confirmed by several faculty members of the Midwifery and Reproductive Health department of Tehran University of Medical Sciences, Tehran, Iran.
Sexual functioning will be assessed using FSFI. This index has nineteen items. Each item is scored with a specific weight. The six subscales of this index are desire (two items with a weight of 0.6), arousal (four items with a weight of 0.3), lubrication (four items with a weight of 0.3), orgasm (three items with a weight of 0.4), satisfaction (three items with a weight of 0.4), and pain (three items with a weight of 0.4). Participants will answer the items on a 0–5 Likert scale on which zero stands for no sexual activity and 5 stands for the highest level of sexual activity in the past 4 weeks. After applying the weight values, the possible total score of the index will be 2–36 [31]. The cutoff score of the index is 28 and scores less than 28 and scores more than 28 are interpreted as sexual dysfunction and normal sexual function, respectively [27]. FSFI is a standard instrument with acceptable validity and reliability [31]. The Cronbach’s alpha values and the test–retest correlation coefficients of the six dimensions of the Persian FSFI in a previous study were 0.73–0.86 and 0.72–0.90, respectively [32].
DASS-21 will be used in eligibility assessment to assess depression, anxiety, and stress. Lovibond and Lovibond developed this 21-item instrument with seven items in each subscale. Items are scored from 1 (“Did not apply to me at all”) to 3 (“Applied to me very much”). The score of each subscale is calculated through summing the scores of its items and is 7–21. As DASS-21 is the short form of DASS-42, the scores of DASS-21 should be doubled before interpretation. The developers of this instrument reported that the Cronbach’s alpha values of its depression, anxiety, and stress subscales were 0.91, 0.81, and 0.89, respectively [28]. A study into the validity and reliability of the Persian DASS-21 reported that the Cronbach’s alpha of its depression, anxiety, and stress subscales were 0.81, 0.74, and 0.78, respectively [33].
The Sexual Quality of Life-Female was developed by Symonds et al. for sexual QOL assessment [34]. This instrument has eighteen items on sexual self-esteem, emotional issues, and relationships which are scored from 1 (“Completely agree”) to 6 (“Completely disagree”). Its possible total score is 18–108, with higher scores showing higher sexual QOL [34]. A study into the psychometric properties of the Persian version of this instrument found that its Cronbach’s alpha and test–retest intraclass correlation coefficient were 0.73 and 0.88, respectively [35].
Intervention for participants in the intervention group
Participants in the intervention group will receive face-to-face SHM-based SE in three 120-min weekly sessions in 7–8-person small groups. Table 2 shows the overall content of the sessions and Table 3 shows the detailed SHM-based content of the sessions. The sessions will be held in a room in the study setting and using the lecture, question-and-answer, group discussion, and educational booklet methods. The booklet will contain the materials which will be provided at face-to-face sessions and then will be provided to participants to be used by them and their husbands. Free telephone counseling sessions will also be held for participants in order to improve their collaboration. At the end of the intervention, a comprehensive educational booklet (containing all materials provided in the sessions) will also be provided to them and they will be invited to ask their questions, if any, through either telephone contacts or face-to-face counseling sessions. The educational sessions will be held by the first author who is a PhD student in reproductive health and has a fifteen-year work experience in the area of reproductive and sexual health.
Development and validity assessment of the intervention
The SHM-based educational intervention will be developed through reviewing the existing literature, interviewing the women who live in the suburbs, and consulting reproductive and sexual health specialists in focus group discussions. The feasibility and importance of the intervention will also be assessed and confirmed in two rounds of nominal group with specialists [36, 37]. After developing the primary draft of the educational intervention, we will carefully read and revise its content and ask ten women from the target population with different educational levels to assess and comment on its comprehensibility. Then, ten specialists in reproductive health, obstetrics, psychology, and psychiatry will assess the draft of the intervention using the second edition of the Appraisal of Guideline for Research and Evaluation (AGREE II). This appraisal has 23 items in six main areas [38].
Intervention for participants in the control group
Participants in the control group will receive SE routinely provided to all women who refer to healthcare centers in the suburbs. For the sake of ethical considerations, SE provided to participants in the intervention group will also be provided to participants in the control group after the posttest through a face-to-face session and an educational booklet.
Data management and analysis
After coding, the collected data will be saved in password protected computers to ensure their confidentiality. Data analysis will be performed using the SPSS software (v. 23.0). The measures of descriptive statistics such as frequency, mean, and standard deviation will be used to present the data and normality will be assessed using the Kolmogorov–Smirnov test. The analysis of covariance as well as the independent-sample t and the Chi-square tests will be employed for between-group comparisons and the paired-sample t test will be used for within-group comparisons. All statistical analyses will be performed using the per protocol analysis and at a significance level of less than 0.05.
Patient and public involvement statement
Interviews with women who live in the suburbs and reproductive and sexual health specialists will help us better determine the needs of these women and develop a need-based educational intervention. We intend to share the results of this study with reproductive and sexual care providers and women who live in the suburbs.
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