Effects of Music on Post-operative Pain and Anxiety

NCT04175574 | Unknown DMC

• 1 other identifier: UPM2019MUSICINMEDICINE
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

It has been hypothesized that because music has the ability to motivate, promote relaxation, alleviate pain and anxiety levels, to distract, and facilitate positive emotional states; thus it will enable healing by reducing anxiety levels which are associated with expected pain, hence patients are more unperturbed. In addition, several studies in the past have also identified that music listening can reduce the need for analgesics before surgery and after surgery to alleviate pain, reduce the period of post-operative pain and aid in the recovery period. While most studies which had administered music listening in the post-anaesthesia care unit (PACU), had found significant findings compared to patients that did not listen to music; there are few others which found otherwise. Over decades, time and again, researchers have tried to understand how non-pharmacological interventions have been utilized in a spectrum of rehabilitation settings in populations to stimulate convalesces. This is because non-pharmacological interventions have been recognised as valuable, simple, safe, and inexpensive adjuvants to pharmacological approaches in pain management and therefore is valuable during post-operative rehabilitation especially. This research is necessary because it hopes to address the gap of knowledge concerning the effects of music in post-operative pain, anxiety objectively in a specific population, and during an explicit time frame in a public hospital setting in Malaysia and whether by listening to music, the patients will require lesser amount of opioids analgesics. The purpose of this study is to examine the effects of music on pain and anxiety during post-operative period in patients with closed shaft femur fracture at University of Malaya Medical Centre.

Conditions

Closed Fracture of Shaft of Femur; Postoperative Pain; Postoperative Anxiety

Keywords

post-operative pain relief; post-operative anxiety; non-pharmacological adjuvant; closed shaft femur fracture; randomised controlled trial

Outcome Measures

Primary Outcomes (3)

• Pain score using the Numeric Rating Scale (NRS)

  Mean score of pain level (1-3 = mild; 4-6 = moderate; 7-10 = severe)

  The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.

• Brief Pain Inventory (BPI)

  Worst, least and average pain in the last 24 hours

  The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.

• Anxiety score using the Generalized Anxiety Disorder-7 (GAD-7)

  Mean score of anxiety level (0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 severe anxiety)

  The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.

Secondary Outcomes (7)

• Opioid dosage

  48 hours post surgery

• Pro-inflammatory cytokine Interleukin 6 (IL-6)

  The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery

• Cortisol level

  The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery

• Heart Rate

  The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery

• Respiratory Rate

  The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention consist of the patients in the experimental group listening to pre-recorded music played through a set of noise cancelling Sony headphones which are padded for extra comfort from a Sony Digital Walkman. The duration of the intervention is 30 minutes without interruption, such as eating, talking and being on their mobile phones.

Other: Music

Control group

NO INTERVENTION

Whereas, patients in the control group will be given similar headphones but without any music. They will also be briefed not to eat, talk and being on their mobile phones.

Interventions

Music OTHER

The music has no lyrics, has a sustained melodic quality, has no strong rhythms and percussion or base, rate of 60-80 beats per minute, promotes relaxation, calming and soothing, neutral and is unbiased towards any culture or age. The volume of the music will be pre-adjusted to the patients' preference (preferable 30 dB) by the research assistant.

Intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Consent to having the surgery and general anaesthesia
• Free from cognitive impairment
• Free from non-communicable diseases
• Mentally stable
• No appreciable deficits in vision and hearing
• American Society of Anaesthesiology (ASA) physical status classification of 1, 2, or 3
• Able to communicate either in English or Bahasa Malaysia
• Admitted to the Orthopaedic ward post-operatively
• Alert and cognizant to complete the pain and anxiety scores

You may not qualify if:

• Patient refusal for surgery and anaesthesia
• Patients anticipated to have difficult airway and planned for higher level airway management such as awake fibreoptic intubation, tracheostomy under local anaesthetic.
• Patients who are cognitively impaired
• Women under hormonal treatment
• Diagnosed with auto immune disease
• Deaf and vision impaired
• Current use of anti-psychotic medication
• Haemodynamically not stable

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• University of Malaya: collaborator

Study Sites (1)

Serdang Hospital

Serdang, Selangor, 43400, Malaysia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Pri H. Chaskar, MMedSc

CONTACT

+601111110600; prichaskar@gmail.com

Manohar Arumugam, MS Ortho

CONTACT

+60193694014; manohar.arumugam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To ensure non-bias during the randomization, both the researcher and the patient will be masked and this procedure will be carried out by a trained research assistant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate student

Model Details: The design of this study is a randomised controlled trial based on the CONSORT 2010 flow diagram. Patients warded at the orthopaedics wards in two government hospitals, who have been hospitalized following a closed midshaft femur fracture and planned for surgery. Patients who fulfill the inclusion criteria will be invited to participate in this study. Recruitment to participate is based on voluntary and they will be given the patient information sheet, written informed consent and briefed on the protocol of the study. The patients will be randomised either in the intervention or control group by selecting an opaque envelope.

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: November 25, 2019
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 2, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)