Pain, Post OperativeNCT05263635
Music Therapy in the Treatment of Perioperative Anxiety and Pain
A study testing Music therapy in people with Pain, Post Operative and Anxiety, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Post Operative, Anxiety, Opioid Use
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2022to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Music Therapy in the Treatment of Perioperative Anxiety and Pain-A Randomized, Prospective, Clinical Trial
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.
Read the 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.
- Conditions
- Pain, Post Operative, Anxiety, Opioid Use
- Being tested
- Music therapy, Standard of Care Enhanced Recovery After Surgery (ERAS)
- Keywords
- Post operative pain management, music therapy, Post-surgical quality of life, hernia repair surgery, ambulatory breast surgery, cholecystectomy
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
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.
Standard of Care Enhanced Recovery After Surgery (ERAS)Other
Patients will receive the standard of care treatment for surgery and post-operative pain management, following the Enhanced Recovery After Surgery (ERAS) protocol
| Study group | Role | What they receive |
|---|---|---|
| Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS) | Experimental | 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. Receives: Other: Music therapy; Other: Standard of Care Enhanced Recovery After Surgery (ERAS) |
| Standard of Care Enhanced Recovery After Surgery (ERAS) | Active comparator | Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no music therapy sessions. Receives: Other: Standard of Care Enhanced Recovery After Surgery (ERAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day of surgery up to 5 days post-operative
Secondary outcomes (10)
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.
Measured: Baseline, pre-surgery
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.
Measured: Day 1, 2, 3, 4, and 5 post-operative
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.
Measured: Baseline, pre-surgery
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.
Measured: Day 1, 2, 3, 4, and 5 post-operative
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
Measured: Baseline, pre-surgery
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.
Measured: Day 1, 2, 3, 4, and 5 post-operative
Length of hospital stay
Evaluate time to hospital discharge from out of OR time in minutes
Measured: Day of surgery up to 5 days post-operative
Incidence of post-operative nausea and vomiting (PONV)
Evaluate the number of post-operative nausea and vomiting episodes following surgery.
Measured: Day of surgery through 5 days post-operative
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.
Measured: Day 5 post-operative
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.
Measured: Day of surgery up to 5 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 May 2022
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Post OperativeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Shadyside Hospital Foundation
- Responsible party
- Principal investigator, Shiv Goel, University of Pittsburgh
- Investigators
- Shiv K Goel, MD, PhD, MBA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263635
- Sponsor's protocol ID
- STUDY21110130
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy in the Treatment of Perioperative Anxiety and Pain-A Randomized, Prospective, Clinical Trial
- ClinicalTrials.gov ID
- NCT05263635
- Acronym / sponsor ID
- STUDY21110130
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Shadyside Hospital Foundation
- Study start
- 5 May 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS) | Experimental | Other: Music therapy, Other: Standard of Care Enhanced Recovery After Surgery (ERAS)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. |
| Standard of Care Enhanced Recovery After Surgery (ERAS) | Active comparator | Other: Standard of Care Enhanced Recovery After Surgery (ERAS)Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no music therapy sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Music other than the intervention planned in the operating room
- ASA status IV
- Planned spinal anesthesia
- Major psychosocial disorders
- Persistent opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyMusic 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. | Other | Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS) |
| Standard of Care Enhanced Recovery After Surgery (ERAS)Patients will receive the standard of care treatment for surgery and post-operative pain management, following the Enhanced Recovery After Surgery (ERAS) protocol | Other | Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS), Standard of Care Enhanced Recovery After Surgery (ERAS) |
Primary outcome
Efficacy of music therapy on reducing post-operative opioid requirement
Time frame: Day of surgery up to 5 days post-operative
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).
10 secondary outcomes
Pre-operative emotional distress related to anxiety
Time frame: Baseline, pre-surgery
Post-operative change in emotional distress related to anxiety
Time frame: Day 1, 2, 3, 4, and 5 post-operative
Pre-operative emotional distress related to depression
Time frame: Baseline, pre-surgery
Post-operative change in emotional distress related to depression
Time frame: Day 1, 2, 3, 4, and 5 post-operative
Pre-operative pain rating using the Pain Catastrophizing Scale
Time frame: Baseline, pre-surgery
Post-operative pain rating using the Pain Catastrophizing Scale
Time frame: Day 1, 2, 3, 4, and 5 post-operative
Length of hospital stay
Time frame: Day of surgery up to 5 days post-operative
Incidence of post-operative nausea and vomiting (PONV)
Time frame: Day of surgery through 5 days post-operative
Post-operative patient satisfaction
Time frame: Day 5 post-operative
Change in post-operative pain using a numerical rating scale
Time frame: Day of surgery up to 5 days post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiv K Goel, MD, PhD, MBA principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Pain, Post Operative and Anxiety, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of music therapy on reducing post-operative opioid requirement (time frame: Day of surgery up to 5 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.