Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Assessment of pain by a 100mm linear visual analogous scale (VAS) related to transvaginal ultrasound-guided oocyte retrieval (TUGOR). Patient will be asked to give the satisfaction score regarding the pain control of TUGOR.
研究概览
简要总结
Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 45（—）
- 性别
- Female
入选标准
- •Patient undergoing transvaginal ultrasound-guided oocyte retrieval
排除标准
- •Patient is suffering from following disease:
- •(2) Endocrine disease including diabetes mellitus, thyroid, hypothalamic, adrenal problems;
- •(3) On steroid therapy;
- •(4) Salivary gland disease;
- •Smoker or drinker;
- •Refuse or incompetence for informed consent.
研究组 & 干预措施
A
One group of patient will be offered a MP3 machine with headphone, however, no music will be played.
B
In another group, no MP3 machine with headphone and no music will be offered.
结局指标
主要结局
Assessment of pain by a 100mm linear visual analogous scale (VAS) related to transvaginal ultrasound-guided oocyte retrieval (TUGOR). Patient will be asked to give the satisfaction score regarding the pain control of TUGOR.
The additional of analgesic during and after TUGOR will be recorded.
Blood pressure, heart rate, respiratory rate, oxygen saturation level will be measured in every 10 minutes during TUGOR.
Assessment of anxiety and stress Basal anxiety level will be assessed by the Chinese version of the Spielberger’s State Anxiety Inventory (STAI) (Appendix I)
12-item General Health Questionnaire (GHQ-12) (Appendix II) and Beck Depression Inventory (BDI) (Appendix III)
Salivary for stress hormone including cortisol and amylase level will be measured before and immediately after TUGOR procedures.
次要结局
- Surgeon’s perception towards adequately of pain and sedation control will be rated using same VAS and satisfactory score.
- Assessment of patient satisfaction Patient attitude towards the treatment will be assessed by an 8-item client satisfaction questionnaire (CSQ-8) (Appendix IV).
- Experience of post-operative side effect will be recorded.
- Sedation and co-operation scale intra-operative sedation and co-operation will be assessed by surgeon of TUGOR and will be scored according to 5-point sedation and co-operation scales.