search
Back to results

Music Therapy in the Treatment of Perioperative Anxiety and Pain

Primary Purpose

Pain, Post Operative, Anxiety, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music therapy
Standard of Care Enhanced Recovery After Surgery (ERAS)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Post Operative focused on measuring Post operative pain management, music therapy, Post-surgical quality of life, hernia repair surgery, ambulatory breast surgery, cholecystectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UPMC Shadyside HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS)

Standard of Care Enhanced Recovery After Surgery (ERAS)

Arm Description

All participants will have complete Enhanced Recovery After Surgery (ERAS) standard of care. A preoperative music intervention will be played first in the preoperative holding 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.

Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no music therapy sessions.

Outcomes

Primary Outcome Measures

Efficacy of music therapy on reducing post-operative opioid requirement
The primary endpoint will be to observe the change in opioid requirement in patients undergoing surgery using the current multimodal Enhanced Recovery After Surgery (ERAS) protocol. This is reported in the consumption of oral morphine mg equivalents (OME).

Secondary Outcome Measures

Pre-operative emotional distress related to anxiety
Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Post-operative change in emotional distress related to anxiety
Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Pre-operative emotional distress related to depression
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Post-operative change in emotional distress related to depression
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Pre-operative pain rating using the Pain Catastrophizing Scale
Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
Post-operative pain rating using the Pain Catastrophizing Scale
Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome.
Length of hospital stay
Evaluate time to hospital discharge from out of OR time in minutes
Incidence of post-operative nausea and vomiting (PONV)
Evaluate the number of post-operative nausea and vomiting episodes following surgery.
Post-operative patient satisfaction
Participants are asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.
Change in post-operative pain using a numerical rating scale
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome.

Full Information

First Posted
February 9, 2022
Last Updated
May 2, 2023
Sponsor
University of Pittsburgh
Collaborators
Shadyside Hospital Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT05263635
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Shadyside Hospital Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS)
Arm Type
Experimental
Arm Description
All participants will have complete Enhanced Recovery After Surgery (ERAS) standard of care. A preoperative music intervention will be played first in the preoperative holding 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.
Arm Title
Standard of Care Enhanced Recovery After Surgery (ERAS)
Arm Type
Active Comparator
Arm Description
Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no music therapy sessions.
Intervention Type
Other
Intervention Name(s)
Music therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care Enhanced Recovery After Surgery (ERAS)
Intervention Description
Patients will receive the standard of care treatment for surgery and post-operative pain management, following the Enhanced Recovery After Surgery (ERAS) protocol
Primary Outcome Measure Information:
Title
Efficacy of music therapy on reducing post-operative opioid requirement
Description
The primary endpoint will be to observe the change in opioid requirement in patients undergoing surgery using the current multimodal Enhanced Recovery After Surgery (ERAS) protocol. This is reported in the consumption of oral morphine mg equivalents (OME).
Time Frame
Day of surgery up to 5 days post-operative
Secondary Outcome Measure Information:
Title
Pre-operative emotional distress related to anxiety
Description
Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time Frame
Baseline, pre-surgery
Title
Post-operative change in emotional distress related to anxiety
Description
Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time Frame
Day 1, 2, 3, 4, and 5 post-operative
Title
Pre-operative emotional distress related to depression
Description
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time Frame
Baseline, pre-surgery
Title
Post-operative change in emotional distress related to depression
Description
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time Frame
Day 1, 2, 3, 4, and 5 post-operative
Title
Pre-operative pain rating using the Pain Catastrophizing Scale
Description
Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
Time Frame
Baseline, pre-surgery
Title
Post-operative pain rating using the Pain Catastrophizing Scale
Description
Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome.
Time Frame
Day 1, 2, 3, 4, and 5 post-operative
Title
Length of hospital stay
Description
Evaluate time to hospital discharge from out of OR time in minutes
Time Frame
Day of surgery up to 5 days post-operative
Title
Incidence of post-operative nausea and vomiting (PONV)
Description
Evaluate the number of post-operative nausea and vomiting episodes following surgery.
Time Frame
Day of surgery through 5 days post-operative
Title
Post-operative patient satisfaction
Description
Participants are asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.
Time Frame
Day 5 post-operative
Title
Change in post-operative pain using a numerical rating scale
Description
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome.
Time Frame
Day of surgery up to 5 days post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Monroe
Phone
412-623-6382
Email
monroeal@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carley Siedlecki
Phone
412-623-2706
Email
siedleckic@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv K Goel, MD, PhD, MBA
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiv K Goel, MD
Email
goelsk@upmc.edu
First Name & Middle Initial & Last Name & Degree
Amy Monroe
Phone
412-623-6382
Email
monroeal@upmc.edu
First Name & Middle Initial & Last Name & Degree
Jacques E Chelly, MD, PhD, MBA

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Music Therapy in the Treatment of Perioperative Anxiety and Pain

We'll reach out to this number within 24 hrs