|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
21 August 2023 |
|
Main ID: |
NCT03415620 |
|
Date of registration:
|
10/01/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction
|
|
Scientific title:
|
The Use of Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction in Patients Undergoing Surgery |
|
Date of first enrolment:
|
January 3, 2018 |
|
Target sample size:
|
410 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03415620 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Singapore
| | | | | | | |
|
Contacts
|
|
Name:
|
Ban Leong Sng, MBBS, MMED |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
KK Women's and Children's Hospital |
|
|
Name:
|
Ban Leong Sng, MBBS, MMED |
|
Address:
|
|
|
Telephone:
|
+6563941081 |
|
Email:
|
sng.ban.leong@singhealth.com.sg |
|
Affiliation:
|
|
|
|
Name:
|
Ban Leong Sng, MBBS, MMED |
|
Address:
|
|
|
Telephone:
|
+6563941081 |
|
Email:
|
sng.ban.leong@singhealth.com.sg |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Healthy participants who are American Society of Anesthesiologists (ASA) 1 and 2 (with
well-controlled medical problems);
- Undergo day surgery, same-day-admission gynecologic surgery or cesarean section;
- No hearing impairment.
Exclusion Criteria:
- Patients with significant respiratory disease and obstructive sleep apnea;
- Patients who are unable to read and understand the hospital anxiety questionnaire.
Age minimum:
21 Years
Age maximum:
70 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Anxiety
|
|
Analgesia
|
|
Music
|
|
Patient Satisfaction
|
|
Pain
|
|
Intervention(s)
|
|
Procedure: Music listening
|
|
Primary Outcome(s)
|
|
Change in Pain score
[Time Frame: Baseline and 1 day]
|
|
Secondary Outcome(s)
|
|
Change in Hospital Anxiety and Depression Scale (HADS) score (Phase 1 only)
[Time Frame: Baseline and 1 day]
|
|
Change in Patient's satisfaction with the use of music listening (only music listening group)
[Time Frame: Baseline and 1 day]
|
|
Change in Analgesia usage
[Time Frame: Baseline and 1 day]
|
|
Change in EQ-5D-3L score
[Time Frame: Baseline and 1 day]
|
|
Change in Visual analog scale - anxiety (VAS-A) score
[Time Frame: Baseline and 1 day]
|
|
Secondary ID(s)
|
|
MT2017-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|