Clinical trial NCT05263635: Music Therapy in the Treatment of Perioperative Anxiety and Pain
Official title: Music Therapy in the Treatment of Perioperative Anxiety and Pain-A Randomized, Prospective, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Post Operative
Anxiety
Opioid Use
Keywords: Post operative pain management
music therapy
Post-surgical quality of life
hernia repair surgery
ambulatory breast surgery
cholecystectomy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Shadyside Hospital Foundation
First posted: 2022-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized single-blind, comparator controlled trial involving patients undergoing ambulatory breast surgery, laparoscopic cholecystectomy surgery, or laparoscopic hernia repair surgery that score ≥19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
Primary purpose: TREATMENT

Brief summary: A large number of adults who undergo surgery experience perioperative anxiety and pain. The current recommended approach to perioperative pain management is a multimodal approach including opioids. Evidence has demonstrated that the pharmacological management of pain and anxiety is often associated with side effects which limits patient satisfaction and their ability to be discharged from the hospital. Furthermore, it is established that perioperative level of pain is directly correlated to anxiety, depression, and catastrophizing and these are significant predictors for the level of postoperative pain, as well as at the hospital length of stay. Therefore, considerations have been given to the use of non-pharmaceutical complementary approaches to management of anxiety including pre and postoperative use of music. The benefits of music therapy on anxiety has been reported using several surgical models and conditions in adults (cancer, hysterectomy in cancer) and children, prior to surgery and after. The objective of this study is to investigate the effects of music interventions on anxiety and pain in adult populations undergoing diverse types of minor surgery indicate that music therapy significantly reduces both post operative anxiety and pain in adults receiving music interventions before, during, or after surgery.

Detailed description: Screening procedures: There are no specific screening tests or procedures for this research study. Medical records will be examined by an investigator anesthesiologist to determine your eligibility for the study. Eligible subjects will be adults between the ages of 18-70 that also meet the American Society of Anesthesiologists (ASA) physical status I, II, or III, and will be admitted for a scheduled same-day surgery under general anesthesia with a single nerve block including ambulatory breast surgeries, laparoscopic cholecystectomy, and/or laparoscopic hernia repair surgeries. This information will be obtained via medical record.

Enrollment procedures: If a subject qualifies to participate in this study, they will discuss this study with the surgeon investigator and the research study team. They will sign an informed consent form and be enrolled if they choose to participate. They will be asked to complete several questionnaires regarding the subject's baseline anxiety and pain prior to their scheduled surgery. These questionnaires will include the PROMIS Emotional Distress - Anxiety - Short Form 8a, PROMIS Emotional Distress - Depression - Short Form, and the Pain Catastrophizing Scale (PCS).

If the subject remains eligible after their self-report baseline questionnaires, they will be randomized to either the control or intervention group. The control group will receive standard of care treatment during their scheduled surgery but will not be exposed to any music therapy intervention during their hospital stay.

For those assigned to the music therapy group, a preoperative music intervention will be played first in the preoperative area, a second music intervention played immediately following the induction of anesthesia in the operating room, and a third music intervention played in the recovery room when the patient is awake and responsive. The music playing device will be removed after each session.

Music therapy will include music intervention based on recommendations from literature such as slow, flowing rhythm, approximately 60-80 beats/minute and played by string instruments, played with a volume of approximately 45 decibel and will be reviewed by qualified music therapists. Aside from the addition of music intervention, standard of care will not be affected.

Randomization will be completed by a computer-generated, blocked randomization list with equal allocation ratio. After obtaining written informed consent, participants will be subsequently allocated using opaque envelopes to the preoperative music intervention group (music administered during the pre-, intra-, and postoperative period) or the control group.

Regardless of which group a subject is randomized to, participants will expected to complete follow-up questionnaires, including a satisfaction survey at the time of discharge.

Follow-up procedures: Subjects will be contacted via email (REDCap Survey) once daily for 5 days post-op and will be asked to complete the same questionnaires they did at the screening visit. In addition to this, they will also be asked to report a daily pain diary, opioid consumption, and treatment satisfaction also in REDCap Survey.

Eligibility criteria: Inclusion Criteria:

* Adults ages 18-70, meeting the American Society of Anesthesiologists (ASA) physical status I, II, or III
* Admitted for a scheduled same-day surgery under general anesthesia with a single nerve block, including ambulatory breast surgery, laparoscopic cholecystectomy or laparoscopic hernia repair surgery

Exclusion Criteria:

* Music other than the intervention planned in the operating room
* ASA status IV
* Planned spinal anesthesia
* Major psychosocial disorders
* Persistent opioid use
* History of drug abuse or alcoholism
* Baseline PROMIS Anxiety score of less than 19 or greater than 35
* Subject is already receiving an alternative intervention for anxiety or pain (i.e aromatherapy, hypnosis, etc)

Primary outcomes:
measure: Efficacy of music therapy on reducing post-operative opioid requirement
timeFrame: Day of surgery up to 5 days post-operative
Secondary outcomes:
measure: Pre-operative emotional distress related to anxiety
timeFrame: Baseline, pre-surgery
measure: Post-operative change in emotional distress related to anxiety
timeFrame: Day 1, 2, 3, 4, and 5 post-operative
measure: Pre-operative emotional distress related to depression
timeFrame: Baseline, pre-surgery
measure: Post-operative change in emotional distress related to depression
timeFrame: Day 1, 2, 3, 4, and 5 post-operative
measure: Pre-operative pain rating using the Pain Catastrophizing Scale
timeFrame: Baseline, pre-surgery
measure: Post-operative pain rating using the Pain Catastrophizing Scale
timeFrame: Day 1, 2, 3, 4, and 5 post-operative
measure: Length of hospital stay
timeFrame: Day of surgery up to 5 days post-operative
measure: Incidence of post-operative nausea and vomiting (PONV)
timeFrame: Day of surgery through 5 days post-operative
measure: Post-operative patient satisfaction
timeFrame: Day 5 post-operative
measure: Change in post-operative pain using a numerical rating scale
timeFrame: Day of surgery up to 5 days post-operative
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Shiv K Goel, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: