Effetto Dell'Integratore Ansileve Sul Funzionamento Genitoriale in Soggetti Esposti a un Evento Emergenziale Per il Bambino: Studio Randomizzato Controllato
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Effect of the spray treatment (Ansileve SOS Spray vs placebo spray) on maternal functioning.
研究概览
简要总结
The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether the dietary supplement Ansileve (Ansileve SOS spray and Ansileve capsules) can improve psychological well-being and parental functioning in mothers and fathers of children experiencing an acute medical event requiring hospital care.
The main questions are:
- Does acute administration of Ansileve SOS spray improve maternal functioning in the short term, as measured by the Barkin Index of Maternal Functioning (BIMF), compared with placebo?
- Does Ansileve SOS spray and the subsequent 30-day supplementation with Ansileve capsules reduce anxiety symptoms and improve emotional well-being in parents, compared with placebo?
Researchers will compare participants receiving Ansileve SOS spray and/or Ansileve capsules with participants receiving matching placebo products to determine whether the intervention improves parental functioning, reduces anxiety symptoms, and supports psychological recovery after a stressful event involving their child.
Participants will:
- Be mothers and fathers (≥18 years) of children admitted for an acute medical event at the Pediatria Immunoreumatologia Unit of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Complete validated questionnaires assessing functioning (BIMF, only mothers), emotional impact of the event [Impact of Event Scale - Revised (IES-R)], and anxiety symptoms [Generalized Anxiety Disorder Scale (GAD-7)] at baseline and during follow-up
- Receive either Ansileve SOS spray or placebo spray at study enrolment.
- Take either Ansileve capsules or placebo capsules daily for 30 days according to the assigned treatment group
- Complete a follow-up assessment to evaluate treatment adherence and possible adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers and fathers of children presenting to the Pediatria Immunoreumatologia Unit of the De Marchi Pediatric Clinic for an acute medical event
- •Age ≥18 years
- •Provision of written informed consent
排除标准
- •Known psychiatric disorders
- •Failure to provide written informed consent
- •Insufficient proficiency in the Italian language
- •Pregnancy or breastfeeding
- •Known allergy or intolerance to one or more components of the food supplement
研究组 & 干预措施
Arm 1: Ansileve SOS Spray + Ansileve Capsules
干预措施: Ansileve SOS Spray (Dietary Supplement)
Arm 1: Ansileve SOS Spray + Ansileve Capsules
干预措施: Ansileve (Dietary Supplement)
Arm 2: Ansileve SOS Spray + Placebo Capsules
干预措施: Ansileve SOS Spray (Dietary Supplement)
Arm 3: Placebo Spray + Ansileve Capsules
干预措施: Ansileve (Dietary Supplement)
Arm 4: Placebo Spray + Placebo Capsules
结局指标
主要结局
Effect of the spray treatment (Ansileve SOS Spray vs placebo spray) on maternal functioning.
时间窗: From baseline (T0) to 30 minutes after spray administration (T1).
Change in maternal functioning after spray administration, measured by the change in BIMF questionnaire score, comparing the Ansileve SOS Spray group with the placebo spray group.
次要结局
- Short-term change in emotional impact and anxiety symptoms after Ansileve SOS Spray in parents.(From baseline (T0) to 30 minutes after spray administration (T1).)
- Long-Term Effects of Ansileve Capsules on Anxiety Symptoms in Parents.(From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).)
- Combined effects of Ansileve SOS Spray and Ansileve capsules on anxiety symptoms in parents(From 30 minutes after spray administration (T1) to 30 days after capsule administration (T2).)