Preoperative AnxietyNCT03651310
Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery
A study testing Music Listening Group in people with Preoperative Anxiety, run by Loyola University at 1 site in United States.
Trial summary
Can music listening decrease a patient's anxiety before surgery? The investigators hypothesize that music listening will decrease a patient's pre-operative anxiety significantly more than no music listening. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Music Listening Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 30 Sep 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are patients of the Loyola University Medical Center Division of Female Pelvic Medicine and Reconstructive Surgery and are scheduled for pelvic reconstructive surgery.
- Women who are 18 years and older.
- There is at least 45 minutes from the time of enrollment to the time patient is transferred to the operating room.
Who cannot join
- Non-English speaking women.
- Women who are currently pregnant or lactating.
- Women who are hearing impaired.
- Women who have participated in this study before.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: The Effect of Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery: A Randomized Trial
Can music listening decrease a patient's anxiety before surgery? The investigators hypothesize that music listening will decrease a patient's pre-operative anxiety significantly more than no music listening.
The investigators aim to see if additional variables affect a patient's anxiety and response to music listening, such as demographic factors (age, race, prior surgical experience, type of surgery planned) and music background (experience playing a musical instrument, music listening habits). The investigators also aim to see if pre-operative music listening is associated with improved patient satisfaction.
Read the detailed description
Does music listening decrease preoperative anxiety in women who are scheduled for pelvic reconstructive surgery? Participants will be approached on the day of pelvic reconstructive surgery while they wait in the pre-operative area for surgery. For the sake of not disrupting the flow of the surgery schedule, patients will be consented approximately 45 minutes before the anticipated start time of surgery. If patient agrees to participate, they will be consented and evaluated for eligibility. Once informed consent is obtained, the patient will be randomized to either the music listening group or the control group. All patients will be asked to complete a STAI-Y1 and demographics questionnaire while awaiting surgery. Those in the music listening group will be asked to answer additional questions regarding their background and experience with music.
Control group:
Participants in the control group will complete another STAI-Y1 questionnaire after 30 minutes of waiting. At the patient's routine 6 weeks postoperative visit, she will be asked to rate her overall satisfaction with her surgery and her satisfaction with the preoperative experience.
Music listening group:
The music listening group will be given a set of noise canceling headphones and an MP3 player with multiple tracks representing different music genres to use while in preoperative area. Patients will be given a handout listing the music genre types and asked to circle which music type they listened to during the study. Genre types include classical instrumental, classical piano, smooth jazz, gospel, and new age. After 30 minutes, patients will be asked to complete another STAI-Y1 questionnaire. They will be given the option to continue listening to music up until the time of surgery; however no additional STAI-Y1 questionnaires will be administered. Headphones and the MP3 player will be taken from the patient as she is being transported to the operating room. The headphones and MP3 player will be cleaned with alcohol wipes and reused for other participants in the study.
At the patient's routine 6 weeks postoperative visit, she will be asked to rate her overall satisfaction with her surgery, her satisfaction with the preoperative experience, and whether she would recommend pre-operative music listening to others.
- Conditions
- Preoperative Anxiety
- Being tested
- Music Listening Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Listening GroupOther
Waiting in preoperative area with music listening.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | waiting in preoperative area without music listening. |
| Music Listening Group | Active comparator | The music listening group will be given a set of noise canceling headphones and an MP3 player with multiple tracks representing different music genres to use while in preoperative area. Receives: Other: Music Listening Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety
The primary variable is anxiety score measured by the State-Trait Anxiety Inventory form Y1 (STAI-Y1) The STAI-Y1 is a 20 item questionnaire which asks subject to rate feelings with a 1-4 pt scale where 1 indicates "not at all" and 4 indicated "very much so". (Range of score 20-80) Higher score equals more anxiety.
Measured: Day 1: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start29 May 2018
- Primary completion15 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thythy Pham, Loyola University
- Investigators
- Thythy Pham, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651310
- Sponsor's protocol ID
- 211003
- Status last verified
- Dec 2019
- First submitted
- 23 Aug 2018
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee J, Kim HS, Shim KD, Park YS. The Effect of Anxiety, Depression, and Optimism on Postoperative Satisfaction and Clinical Outcomes in Lumbar Spinal Stenosis and Degenerative Spondylolisthesis Patients: Cohort Study. Clin Orthop Surg. 2017 Jun;9(2):177-183. doi: 10.4055/cios.2017.9.2.177. Epub 2017 May 8.
PubMed 28567219Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
PubMed 23740695Rosen S, Svensson M, Nilsson U. Calm or not calm: the question of anxiety in the perianesthesia patient. J Perianesth Nurs. 2008 Aug;23(4):237-46. doi: 10.1016/j.jopan.2008.05.002.
PubMed 18657759Wang TF, Wu YT, Tseng CF, Chou C. Associations between dental anxiety and postoperative pain following extraction of horizontally impacted wisdom teeth: A prospective observational study. Medicine (Baltimore). 2017 Nov;96(47):e8665. doi: 10.1097/MD.0000000000008665.
PubMed 29381942Chen YB, Barnes H, Westbay L, Wolff B, Shannon M, Adams W, Acevedo-Alvarez M, Mueller ER, Pham TT. Preoperative Music Listening in Pelvic Reconstructive Surgery: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2021 Aug 1;27(8):469-473. doi: 10.1097/SPV.0000000000001070.
PubMed 34397606
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03651310
- Acronym / sponsor ID
- 211003
- Conditions
- Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 29 Aug 2018 (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.
Can music listening decrease a patient's anxiety before surgery? The investigators hypothesize that music listening will decrease a patient's pre-operative anxiety significantly more than no music listening.
The investigators aim to see if additional variables affect a patient's anxiety and response to music listening, such as demographic factors (age, race, prior surgical experience, type of surgery planned) and music background (experience playing a musical instrument, music listening habits). The investigators also aim to see if pre-operative music listening is associated with improved patient satisfaction.
Detailed description
Does music listening decrease preoperative anxiety in women who are scheduled for pelvic reconstructive surgery? Participants will be approached on the day of pelvic reconstructive surgery while they wait in the pre-operative area for surgery. For the sake of not disrupting the flow of the surgery schedule, patients will be consented approximately 45 minutes before the anticipated start time of surgery. If patient agrees to participate, they will be consented and evaluated for eligibility. Once informed consent is obtained, the patient will be randomized to either the music listening group or the control group. All patients will be asked to complete a STAI-Y1 and demographics questionnaire while awaiting surgery. Those in the music listening group will be asked to answer additional questions regarding their background and experience with music.
Control group:
Participants in the control group will complete another STAI-Y1 questionnaire after 30 minutes of waiting. At the patient's routine 6 weeks postoperative visit, she will be asked to rate her overall satisfaction with her surgery and her satisfaction with the preoperative experience.
Music listening group:
The music listening group will be given a set of noise canceling headphones and an MP3 player with multiple tracks representing different music genres to use while in preoperative area. Patients will be given a handout listing the music genre types and asked to circle which music type they listened to during the study. Genre types include classical instrumental, classical piano, smooth jazz, gospel, and new age. After 30 minutes, patients will be asked to complete another STAI-Y1 questionnaire. They will be given the option to continue listening to music up until the time of surgery; however no additional STAI-Y1 questionnaires will be administered. Headphones and the MP3 player will be taken from the patient as she is being transported to the operating room. The headphones and MP3 player will be cleaned with alcohol wipes and reused for other participants in the study.
At the patient's routine 6 weeks postoperative visit, she will be asked to rate her overall satisfaction with her surgery, her satisfaction with the preoperative experience, and whether she would recommend pre-operative music listening to others.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –waiting in preoperative area without music listening. |
| Music Listening Group | Active comparator | Other: Music Listening GroupThe music listening group will be given a set of noise canceling headphones and an MP3 player with multiple tracks representing different music genres to use while in preoperative area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who are patients of the Loyola University Medical Center Division of Female Pelvic Medicine and Reconstructive Surgery and are scheduled for pelvic reconstructive surgery.
- Women who are 18 years and older.
- There is at least 45 minutes from the time of enrollment to the time patient is transferred to the operating room.
Key exclusion criteria (4 listed)
- Non-English speaking women.
- Women who are currently pregnant or lactating.
- Women who are hearing impaired.
- Women who have participated in this study before.
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 Listening GroupWaiting in preoperative area with music listening. | Other | Music Listening Group |
Primary outcome
Preoperative Anxiety
Time frame: Day 1: 30 minutes
The primary variable is anxiety score measured by the State-Trait Anxiety Inventory form Y1 (STAI-Y1) The STAI-Y1 is a 20 item questionnaire which asks subject to rate feelings with a 1-4 pt scale where 1 indicates "not at all" and 4 indicated "very much so". (Range of score 20-80) Higher score equals more anxiety.
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 5 Dec 2019.
- Results publication: PubMed 28567219Lee J, Kim HS, Shim KD, Park YS. The Effect of Anxiety, Depression, and Optimism on Postoperative Satisfaction and Clinical Outcomes in Lumbar Spinal Stenosis and Degenerative Spondylolisthesis Patients: Cohort Study. Clin Orthop Surg. 2017 Jun;9(2):177-183. doi: 10.4055/cios.2017.9.2.177. Epub 2017 May 8.
- Results publication: PubMed 23740695Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
- Results publication: PubMed 18657759Rosen S, Svensson M, Nilsson U. Calm or not calm: the question of anxiety in the perianesthesia patient. J Perianesth Nurs. 2008 Aug;23(4):237-46. doi: 10.1016/j.jopan.2008.05.002.
- Results publication: PubMed 29381942Wang TF, Wu YT, Tseng CF, Chou C. Associations between dental anxiety and postoperative pain following extraction of horizontally impacted wisdom teeth: A prospective observational study. Medicine (Baltimore). 2017 Nov;96(47):e8665. doi: 10.1097/MD.0000000000008665.
- Derived from this study: PubMed 34397606Chen YB, Barnes H, Westbay L, Wolff B, Shannon M, Adams W, Acevedo-Alvarez M, Mueller ER, Pham TT. Preoperative Music Listening in Pelvic Reconstructive Surgery: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2021 Aug 1;27(8):469-473. doi: 10.1097/SPV.0000000000001070.
- Individual participant dataSharing planned: Undecided
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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.
Thythy Pham, MD principal investigator
Loyola University
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 Listening Group in people with Preoperative Anxiety, run by Loyola University 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 3 inclusion and 4 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 5 Dec 2019. 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?
Preoperative Anxiety (time frame: Day 1: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03651310, which also lists 5 linked publications.
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 5 Dec 2019.