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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03226028
Other study ID # MT2017
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 4, 2017
Est. completion date December 31, 2023

Study information

Verified date January 2023
Source KK Women's and Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The capacity of music to relieve pain has been used in many forms of medicines and has been proven to reduce anxiety, pain and need for analgesia in perioperative setting. However, music listening as an inexpensive and duplicable method has not been studied in the local context. The investigators hereby propose a prospective study to recruit women who undergo surgery to evaluate the effectiveness of music in pain relief and post-operative recovery in KKH; as well as the possibility of implementing music listening in perioperative setting. The patients will be offered to listen to one out of several pre-determined lists of music of different genres before, and after surgery. Data including pain score, Hospital Anxiety and Depression Scale (HADS) score, EuroQol-Five Dimensions questionnaire-using Three Levels (EQ-5D-3L), vital signs, analgesia usage and patient satisfaction will be collected in the perioperative period. The collected data shall also be assessed if they are affected by the presence of music, duration of music listening, and the genre chosen by the patients. The investigators believe that this study could help determine the clinical relevance of music for pain relief in local setting, which potentially could reduce patient pain and anxiety caused by surgery. This in turn could allow music listening to be adopted as a non-invasive pain relief intervention in local healthcare settings and further improve patient outcome with lower cost and greater convenience as well as safety.


Description:

Some tissue injury is unavoidable during surgery, but pain and anxiety are (nearly as often) also unavoidable in the perioperative period. Acute post-operative pain and anxiety have been managed via pharmacological interventions such as opioid-based analgesia for over a century. However, non-pharmacological interventions - such as music - have also been shown to safe and cost-effective, to improve the overall patient experience, and improve outcomes across a variety of surgical settings. Music has been shown to decrease pain in the perioperative period, to reduce plasma, urine, and salivary cortisol levels, modulate the inflammatory response (natural killer lymphocytes), blood pressure, and heart rate.Additionally, anxiety scores and pain scores (measured using the visual analog scale (VAS)) have shown statistically significant reductions in the perioperative period, when music therapy was available. From 1 April 2015 to 31 March 2016, there were 31,871 surgeries done in KK Women's and Children's Hospital (KKH). While music therapy in the hospital has been offered as a part of cognitive rehabilitation services or end of life care, there is little investigation found on its effect if used perioperatively in adult patients who undergo surgeries, especially in local setting. Based on the above rationale, the investigators shall therefore investigate the feasibility and practicability of deploying music listening in pain management in KKH, and further determine the nature of the music (duration, genre) by fitting the local context in order to improve the patient outcome in perioperative settings.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria: - Healthy participants who are American Society of Anesthesiologists (ASA) 1 and 2 (with well-controlled medical problems); - Undergo day surgery or same-day-admission gynecologic surgery; - 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; - Obstetric patients.

Study Design


Intervention

Procedure:
Music listening
Patient is given an ipod with earphone and with saved playlists of different music genres. Music listening session will be given for 30 minutes before and after surgery. Questionnaires will be asked to fill in. All the earphones will be disinfected following the hospital's infection control guideline.

Locations

Country Name City State
Singapore KK Women's and Children's Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Tan DJA, Polascik BA, Kee HM, Hui Lee AC, Sultana R, Kwan M, Raghunathan K, Belden CM, Sng BL. The Effect of Perioperative Music Listening on Patient Satisfaction, Anxiety, and Depression: A Quasiexperimental Study. Anesthesiol Res Pract. 2020 Feb 7;2020: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pain score Difference of Pain score before and after surgery Baseline and 1 day
Secondary Change in Analgesia usage Analgesia usage before and after surgery Baseline and 1 day
Secondary Change in Patient's satisfaction with the use of music listening Patient's satisfaction on music listening before and after surgery Baseline and 1 day
Secondary Change in Hospital Anxiety and Depression Scale (HADS) score HADS Anxiety and Depression score before and after surgery Baseline and 1 day
Secondary Change in EQ-5D-3L score EQ-5D-3L score before and after surgery Baseline and 1 day
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