Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-70
SponsorKK Women's and Children's Hospital
About this trial
The use of music to relieve pain has been studied in many forms of medicines and has been proven to reduce anxiety, pain and analgesic use in the perioperative setting. However, music listening as an inexpensive and duplicable method has not been investigated and implemented in the local context. The investigators hereby propose a prospective study to recruit patients undergoing surgery to evaluate the effectiveness of music in pain relief and post-operative recovery; as well as the implementation and operational readiness of music listening.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with significant respiratory disease and obstructive sleep apnea;
Patients who are unable to read and understand the hospital anxiety questionnaire.
Trial design
Design model
Single group
Treatments tested in this trial
Music listening
Procedure/SurgeryPatient is given an ipod with earphone and with saved playlist of different music genres. Music listening session will be given for 30 minutes before, during and after surgery. Questionnaires will be asked to fill in. All the earphones will be disinfected following the hospital's infection control guideline.
Treatment groups
410 Participants
are divided into 2 treatment groupsGroup A: Music listeningExperimental treatment 1 intervention
Group B: No Music ListeningNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Pain score
Difference of Pain score before and after surgery. Pain scores (Numeric Rating Scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.
Time frame
Baseline and 1 daySecondary outcomes
1
Change in Analgesia usage
Analgesia usage (name and dosage of pain medication) used before and after surgery
Time frame
Baseline and 1 day2
Change in Patient's satisfaction with the use of music listening (only music listening group)
Patient's satisfaction on music listening before and after surgery. Patient will be asked on their satisfaction level based on ordinal scale (Excellent, Good, Fair, Poor).
Time frame
Baseline and 1 day3
Change in Hospital Anxiety and Depression Scale (HADS) score (Phase 1 only)
HADS Anxiety and Depression score before and after surgery. HADS is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. For each subscore (anxiety/depression), 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); and 11-21 = Abnormal (case).
Time frame
Baseline and 1 day4
Change in EQ-5D-3L score
EQ-5D-3L score before and after surgery. EQ-5D-3L is a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".
Time frame
Baseline and 1 daySponsors and contacts
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Source ClinicalTrials.gov