Effectiveness of Progressive Muscle Relaxation and Laughter Therapy on Mental Health and Treatment Outcomes in Women Undergoing In Vitro Fertilization: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Mental health state (Depression)
研究概览
简要总结
Purpose: This study was aimed to evaluate the effect of progressive muscle relaxation exercises and laughter therapy on the mental health and treatment outcomes of women receiving IVF treatment.
Design: Randomized controlled trial with two parallel groups Methods: Participants were randomly assigned to the intervention (IG; n = 71) and control group (CG; n = 70). The progressive muscle relaxation and laughter therapy was administered to women in the intervention group in the IVF center for 3-4 times and 40 minutes. The CG received routine care. Data were collected using baseline and oocyte retrieval day STAI and BDI.
详细描述
Infertility, one of the important components of reproductive health, affects one in four couples in developing countries.The emergence of assisted reproductive techniques such as in vitro fertilization (IVF) gives infertile couples the opportunity to have both pregnancy and a baby. Couples are affected emotionally during IVF treatment and women experience more problems than men. The majority of women experience emotional problems such as anxiety and depression because of infertility, invasive treatment procedures, physiological effects of gonadotropin stimulation and positive outcome expectation.Considering the effect of anxiety and depression on infertile women, it is important to examine the effectiveness of progressive muscle relaxation exercises and laughter therapy as complementary therapy in psychosocial care.
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
- Single (Outcomes Assessor)
盲法说明
Statistical and reporting blinding were provided in the study.
入排标准
- 年龄范围
- 20 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 20 and 46,
- •Literate in Turkish language,
- •Diagnosed with infertility by an obstetrician or medical doctor
- •Those with primary or secondary infertility
排除标准
- •A diagnosed psychiatric disorder,
- •prior experience in relaxation intervention,
- •Lack of ovarian response in previous treatments
- •Undergoing frozen embryo transfer.
研究组 & 干预措施
intervention group
In the first session of the researcher (S.K.), the participants were explained the effects of anxiety and stress on the treatment in simple terms for 5 min. Then, information was given about the effects of laughter therapy and progressive muscle relaxation on the body. Laughter therapy was applied for 15-20 min. Then, the lights were turned off and progressive muscle relaxation exercises were performed for 15-20 min under candlelight and accompanied by music. The procedures were received as a group (2-6 people) in 3-4 face-to-face sessions.
干预措施: Progressive muscle relaxation+laughter therapy (Behavioral)
Control group
The control group then received routine care
结局指标
主要结局
Mental health state (Depression)
时间窗: Before intervention begins and through intervention completion on average of 15 days
State Trait Anxiety Inventory (STAI): To measure anxiety levels of the participants, the Turkish version of STAI developed by Spielberger was used. High scores indicate high anxiety level, while low scores indicate less anxiety level.
Mental health state (anxiety)
时间窗: Before intervention begins and through intervention completion on average of 15 days
Beck Depression Inventory: The Beck Depression Inventory (BDI) is a 21-item self-reporting scale consisting of emotional, cognitive, somatic, and motivational components to measure the level and severity changes of depressive symptoms. In BDI, it is seen that as the total score obtained from the scale increases, the individual's level of experiencing depressive emotions increases proportionally.
次要结局
- Fertility treatment results(15 days after embryo transfer)
- Fertility treatment results(Before intervention begins and a cycle of ovarian stimulation (15 days))
- Fertility treatment results(a cycle of ovarian stimulation (15 days))
- Fertility treatment results(3-5 days after oocyte pick up day)
研究者
Sibel Kıyak
Assist. Professor
Necmettin Erbakan University