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Trial History Detail on 2012-11-08

CUHK_CCT00300

2011-09-30

Prospective

Nil

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

Nil

Nil

Carol Chan

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

26321764

carolchan@cuhk.edu.hk

Nil

Dr. Wai Yee Wong

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

26322583

alicewywong@cuhk.edu.hk

Nil

Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial

Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial

Nil

Hong Kong

Yes

2011-08-29

infertile women undergoing oocyte retrieval are to be recruited

Other

Music

Music

Music will be offered to patient during oocyte retrieval by MP3 machine with headphone

One group of patient will be offered a MP3 machine with headphone, however, no music will be played. In another group, no MP3 machine with headphone and no music will be offered.

Patient undergoing transvaginal ultrasound-guided oocyte retrieval

1. Patient is suffering from following disease
i)Deaf ii)Endocrine disease including diabetes mellitus, thyroid, hypothalamic, adrenal problems iii)On steroid therapy iv)Salivary gland disease
2. Smoker or drinker
3. Refuse or incompetence for informed consent

18

45

Female

Interventional

Randomized

Placebo

Open label

Parallel

2011-10-01

180

Complete

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. Surgeon’s perception towards adequately of pain and sedation control will be rated using same VAS and satisfactory score. 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.

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.

No

2012-11-08

ChiCTR-TRC-11001657

2011-11-04


Yes

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