Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Change in the FSFI score from baseline to two months
研究概览
简要总结
Sexual dysfunction is common in pregnant women (46.6%, 34.4%, and 73.3% in women in the first, second, and third trimester worldwide, respectively). These dysfunctions can persist after childbirth, affecting quality of life, marriage satisfaction, and family happiness. In Vietnam, a country heavily influenced by the Eastern traditions, sexual activity is considered private and only shared between husband and wife. Many women have wrong beliefs that having sexual intercouse during pregnancy will affect the safety of the fetus, and thus, are reluctant to engage in sexual activity with their husband. Interventions have been developed to improve the quality of sexual function in pregnant women.
In Vietnam, data of sexual dysfunction in pregnant women are somewhat limited, and there have been no programs to improve the sexual function for this population. Therefore, the study team plans to develop an educational program with aim to improve the quality of sexual function in Vietnamese pregnant women. This study aims to investigate the prevalence and associated factors of sexual dysfunction in first-trimester pregnant women and evaluate the effectiveness of the educational program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women whose gestational age is less than or equal to 12 weeks.
- •Currently living with husband/partner.
- •No signs and symptoms of first trimester complications (eg, threated abortion).
排除标准
- •Getting pregnant from in vitro fertilization or having a history of preterm birth.
- •Having serious health conditions that require abortion.
- •Illiterate, or having mental illness or incapacity.
- •Having a fetus diagnosed with anomalies.
- •Does not agree to participate.
结局指标
主要结局
Change in the FSFI score from baseline to two months
时间窗: Two months
Patients are followed up after two months and repeated the FSFI. The difference between the baseline total FSFI score and the two-month total FSFI score is calculated. The mean difference is calculated for the intervention and the control arm.
Prevalence of sexual dysfunction in pregnant women
时间窗: Baseline
Sexual function is evaluated using the Female Sexual Function Index (FSFI). The FSFI includes 19 questions covering six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Questions ask about participant's sexual experience during the past four weeks, rating the degree/frequency of their experience on a scale from "not at all" or "never" to "very" or "always". Four questions score 1-5 and fifteen score 0-5. Then, the scores of questions in an individual domain are added and the total score is multiplied by the domain factor. Finally, the six domain scores are added to obtain the full scale score. A total FSFI score of \<= 26.55 is considered sexual dysfunction.
次要结局
- Change in knowledge and attitude at two months(Two months)
研究者
PHAN CHI PHAN
Principal Investigator
National Hospital of Obstetrics and Gynecology