Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00300

2 Trial Registration Date

2011-09-30

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

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

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Carol Chan

ii Address

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

iii Phone

26321764

iv Email

carolchan@cuhk.edu.hk

v Affiliation

Nil

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Wai Yee Wong

ii Address

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

iii Phone

26322583

iv Email

alicewywong@cuhk.edu.hk

v Affiliation

Nil

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-08-29

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

infertile women undergoing oocyte retrieval are to be recruited

15 Intervention

i Types of intervention

Other

Please specify

Music

ii Description/ name of Intervention/article

Music

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

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

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patient undergoing transvaginal ultrasound-guided oocyte retrieval

ii Exclusion Criteria

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

iii Age Minimum

18

iv Age Maximum

45

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-10-01

21 Target Sample Size

180

22 Recruitment Status

Recruiting

23 Primary Outcome

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.

24 Secondary Outcome

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.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-11-08

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-11-04