Perioperative AnxietyEMBAGNCT05572437
Perioperative Effect of Music in Patients Undergoing General Anesthesia
A study testing Music Therapy in people with Perioperative Anxiety and Postoperative Pain, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial summary
Anxiety is a transient emotional state characterized by feelings of tension, apprehension, nervousness, fear, and heightened activation of the autonomic nervous system in response to a specific current or potential event or situation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Perioperative Anxiety, Postoperative Pain
- What is being tested?
- Music Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2022to 30 Apr 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients over 18 years of age and under 60 years of age
- Classification of the American Society of Anesthesiologists (ASA) I-IV
- Intervened on a scheduled basis for general surgery.
- Signed informed consent prior to surgery.
Who cannot join
- Refusal of the patient to participate in the study.
- Patients under 18 years of age or incapable of giving their consent.
- ASA V.
- History of hypersensitivity to contact devices
- Patients with total hearing impairment
- Patients with substance abuse use disorders
- Patients with cognitive deficit
Trial locations and contacts
1 site in 1 country.
About this study
Anxiety is a transient emotional state characterized by feelings of tension, apprehension, nervousness, fear, and heightened activation of the autonomic nervous system in response to a specific current or potential event or situation. Music therapy is a cost-effective and safe intervention applied to health care, that has been incorporated into different branches of medicine, including anesthesiology, showing economic benefits and as an adjunct to pharmacological therapy, allowing the use of lower doses of perioperative drugs, thus reducing their deleterious effects. The main objective of this randomized clinical trial is to evaluate whether the application of music during the perioperative period reduces perioperative anxiety in patients undergoing general and digestive surgery under general anesthesia.Patients between 18 and 60 years of age, classified according to the American Society of Anesthesiologists (ASA) I-IV, scheduled for general surgery and who have signed the informed consent, will be randomized to receive music therapy in the immediate perioperative period or not. Perioperative anxiety, stay in the PACU, incidence of postoperative pain and intraoperative opioid consumption will be compared between both groups.
Read the detailed description
Anxiety is a transient emotional state characterized by feelings of tension, apprehension, nervousness, fear, and heightened activation of the autonomic nervous system in response to a specific current or potential event or situation. Music therapy is a cost-effective, non-invasive and safe intervention applied to health care, whose boom has grown gradually in recent years until it has been incorporated into different branches of medicine, including anesthesiology , showing economic benefits and as an adjunct to pharmacological therapy, since it allows the use of lower doses of some drugs, thus reducing their deleterious effects. The main objective of this randomized clinical trial is to evaluate whether the application of music during the perioperative period reduces perioperative anxiety in patients undergoing general and digestive surgery under general anesthesia. Patients between 18 and 60 years of age, classified according to the American Society of Anesthesiologists (ASA) I-IV, scheduled for general surgery and who have signed the informed consent, will be randomized to receive music therapy in the immediate perioperative period or not. Patients randomized to the control group will be assessed for preoperative anxiety using the APAIS and the STAI scales in the preoperative room and assessment of insomnia using the ISI scale both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured using the VAS scale in the PACU and on the first day in the hospital ward. Patients randomized to the treatment with music group (classical music), after assessment of anxiety using the APAIS and STAI scales, will be given headphones and classical music will be played from their stay in the pre-surgery room, during surgery and in the PACU.All patients will have their anxiety assessed in the pre-anesthesia room and insomnia assessed both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured in the PACU and on the first day in the hospitalization ward. Perioperative anxiety, stay in the PACU, incidence of postoperative pain and intraoperative opioid consumption will be compared between both groups.
- Conditions
- Perioperative Anxiety, Postoperative Pain
- Being tested
- Music Therapy
- Keywords
- Anxiety, Perioperative, Insomnia
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyDevice
Patients randomized to the treatment with music group (classical music), after assessment of anxiety using the APAIS scale, will be given headphones and classical music will be played from their stay in the pre-anesthesia room, during surgery and in the PACU.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients randomized to the control group will be assessed for preoperative anxiety using the APAIS scale in the preoperative room and assessment of insomnia using the ISI scale both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured using the VAS scale in the PACU and on the first day on the hospital ward. |
| Intervention Group | Experimental | Patients randomized to the treatment with music group (classical music), after assessment of anxiety using the APAIS scale, will be given headphones and classical music will be played from their stay in the pre-surgery room, during surgery and in the PACU. Receives: Device: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative anxiety
Specific anxiety questionnaires (APAIS, STAI) will be applied on arrival at the pre-anesthesia room, prior to anesthetic induction and after arrival at the post-anesthetic recovery unit.
Measured: from the arrival to the preanesthesia room to the 4 postoperative hour
Secondary outcomes (1)
Postoperative pain
Postoperative pain will be assessed using the visual analog scale in the immediate postoperative period.
Measured: From the first postoperative hour to the 4th postoperative hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start15 Oct 2022
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization of the patients will be carried out by a collaborating researcher through a computer program (Excel 2016) at the time of inclusion in the study. This collaborating researcher will not be able to be present at the surgical intervention and will contact the nursing staff by telephone, indicating which patient should be given music therapy upon arrival in the pre-surgery room.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ángel Becerra, PhD, Principal investigator, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572437
- Sponsor's protocol ID
- 2020-370-1
- Acronym
- EMBAG
- Status last verified
- Aug 2024
- First submitted
- 5 Oct 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are to be shared with other researchers when required once the study is completed and global data are published.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Effect of Music in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT05572437
- Acronym / sponsor ID
- EMBAG / 2020-370-1
- Conditions
- Perioperative Anxiety, Postoperative Pain
- Keywords
- Anxiety, Perioperative, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Oct 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.
Anxiety is a transient emotional state characterized by feelings of tension, apprehension, nervousness, fear, and heightened activation of the autonomic nervous system in response to a specific current or potential event or situation. Music therapy is a cost-effective and safe intervention applied to health care, that has been incorporated into different branches of medicine, including anesthesiology, showing economic benefits and as an adjunct to pharmacological therapy, allowing the use of lower doses of perioperative drugs, thus reducing their deleterious effects. The main objective of this randomized clinical trial is to evaluate whether the application of music during the perioperative period reduces perioperative anxiety in patients undergoing general and digestive surgery under general anesthesia.Patients between 18 and 60 years of age, classified according to the American Society of Anesthesiologists (ASA) I-IV, scheduled for general surgery and who have signed the informed consent, will be randomized to receive music therapy in the immediate perioperative period or not. Perioperative anxiety, stay in the PACU, incidence of postoperative pain and intraoperative opioid consumption will be compared between both groups.
Detailed description
Anxiety is a transient emotional state characterized by feelings of tension, apprehension, nervousness, fear, and heightened activation of the autonomic nervous system in response to a specific current or potential event or situation. Music therapy is a cost-effective, non-invasive and safe intervention applied to health care, whose boom has grown gradually in recent years until it has been incorporated into different branches of medicine, including anesthesiology , showing economic benefits and as an adjunct to pharmacological therapy, since it allows the use of lower doses of some drugs, thus reducing their deleterious effects. The main objective of this randomized clinical trial is to evaluate whether the application of music during the perioperative period reduces perioperative anxiety in patients undergoing general and digestive surgery under general anesthesia. Patients between 18 and 60 years of age, classified according to the American Society of Anesthesiologists (ASA) I-IV, scheduled for general surgery and who have signed the informed consent, will be randomized to receive music therapy in the immediate perioperative period or not. Patients randomized to the control group will be assessed for preoperative anxiety using the APAIS and the STAI scales in the preoperative room and assessment of insomnia using the ISI scale both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured using the VAS scale in the PACU and on the first day in the hospital ward. Patients randomized to the treatment with music group (classical music), after assessment of anxiety using the APAIS and STAI scales, will be given headphones and classical music will be played from their stay in the pre-surgery room, during surgery and in the PACU.All patients will have their anxiety assessed in the pre-anesthesia room and insomnia assessed both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured in the PACU and on the first day in the hospitalization ward. Perioperative anxiety, stay in the PACU, incidence of postoperative pain and intraoperative opioid consumption will be compared between both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The randomization of the patients will be carried out by a collaborating researcher through a computer program (Excel 2016) at the time of inclusion in the study. This collaborating researcher will not be able to be present at the surgical intervention and will contact the nursing staff by telephone, indicating which patient should be given music therapy upon arrival in the pre-surgery room.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients randomized to the control group will be assessed for preoperative anxiety using the APAIS scale in the preoperative room and assessment of insomnia using the ISI scale both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured using the VAS scale in the PACU and on the first day on the hospital ward. |
| Intervention Group | Experimental | Device: Music TherapyPatients randomized to the treatment with music group (classical music), after assessment of anxiety using the APAIS scale, will be given headphones and classical music will be played from their stay in the pre-surgery room, during surgery and in the PACU. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age and under 60 years of age
- Classification of the American Society of Anesthesiologists (ASA) I-IV
- Intervened on a scheduled basis for general surgery.
- Signed informed consent prior to surgery.
Key exclusion criteria (7 listed)
- Refusal of the patient to participate in the study.
- Patients under 18 years of age or incapable of giving their consent.
- ASA V.
- History of hypersensitivity to contact devices
- Patients with total hearing impairment
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 TherapyPatients randomized to the treatment with music group (classical music), after assessment of anxiety using the APAIS scale, will be given headphones and classical music will be played from their stay in the pre-anesthesia room, during surgery and in the PACU. | Device | Intervention Group |
Primary outcome
Perioperative anxiety
Time frame: from the arrival to the preanesthesia room to the 4 postoperative hour
Specific anxiety questionnaires (APAIS, STAI) will be applied on arrival at the pre-anesthesia room, prior to anesthetic induction and after arrival at the post-anesthetic recovery unit.
1 secondary outcome
Postoperative pain
Time frame: From the first postoperative hour to the 4th postoperative hour.
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 7 Aug 2024.
- Individual participant dataSharing planned: No. IPD are to be shared with other researchers when required once the study is completed and global data are published.
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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.
Ángel Becerra, PhD principal investigator
Hospital Universitario de Gran Canaria Doctor Negrín
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 Perioperative Anxiety and Postoperative Pain, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
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 4 inclusion and 7 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 7 Aug 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 Spain. 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?
Perioperative anxiety (time frame: from the arrival to the preanesthesia room to the 4 postoperative hour). 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 7 Aug 2024.