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Trial History Detail on 2011-09-30

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

Nil

Patient undergoing transvaginal ultrasound-guided oocyte retrieval

1. Patient is suffering from following disease
 Deaf
 Endocrine disease including diabetes mellitus, thyroid, hypothalamic, adrenal problems
 On steroid therapy
 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

Not Yet Recruiting

Assessment of pain
Research assistance who is not involved in the TUGOR will ask patients about the pain level by a 100mm linear visual analogous scale (VAS). Before operation, patient will be asked to give pain level in related to venepuncture, transvaginal scanning, the insertion of IV cannula and anticipated TUGOR. This is to assess the baseline pain perception for the patients. After the operation, the maximum level of vaginal and abdominal pain during TUGOR will be rated by patient shortly after TUGOR. Patient will be asked to rate the abdominal and vaginal pain again 4 hour after TUGOR (before discharge). Patient will be asked to give the satisfaction score regarding the pain control of TUGOR: excellent, satisfactory, fair and unsatisfactory. For those patients had undergone previous oocyte retrieval by conscious sedation alone, they will ask whether they prefer the present treatment modality or not. 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. All the sample collection will be done between 10:00am to 12:00 pm to prevent diurnal variation.

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
Severity of post-operative side effects including nausea, vomiting, drowsiness and dizziness will be rated by patient into four grades: none, mild, moderate, severe.

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.

Difficulty in retrieving oocytes
This will be scored by surgeon and recorded as follows: easy to mildly difficult, moderately difficult or very difficult. Number of uterine or cervical puncture will also be recorded.

IVF parameters
Patient clinical parameters during the IVF procedures including estrogen and progesterone level on day of oocyte retrieval, the number of oocytes retrieve, cycles with intra-cytoplasmic sperm injection, fertilization rate, cleavage rate, number of embryos transferred/frozen and clinical pregnancy rate will be recorded.

No

2012-11-08


Yes

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