Bariatric SurgeryBSMusicPONVNCT06048952
The Effect of Music Therapy After Bariatric Surgery on Postoperative Nausea Vomiting and Patient Satisfaction
A study testing Music Therapy in people with Bariatric Surgery, run by Sibel Yilmaz Sahin at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was planned to evaluate the effectiveness of the use of music therapy, which is a non-pharmacological method, in addition to pharmacological treatment in patients with PONV after bariatric surgery, whose application frequency is increasing in the treatment of obesity, and to determine its effect on… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2021to 14 Oct 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cognitive functions are sufficient,
- Able to communicate in Turkish,
- Between the ages of 18-80,
- Patients who voluntarily participated in the study
Who cannot join
- Patients who did not volunteer for the study,
- Patients who underwent open surgery
- whose mother tongue is not Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bariatrik Cerrahi Sonrası Müzik Terapinin Postoperatif Bulantı Kusmayı Azaltma ve Hasta Memnuniyeti Üzerine Etkisi
In this study, it was planned to evaluate the effectiveness of the use of music therapy, which is a non-pharmacological method, in addition to pharmacological treatment in patients with PONV after bariatric surgery, whose application frequency is increasing in the treatment of obesity, and to determine its effect on patient satisfaction. The findings of this study are considered to be effective in preventing nausea and vomiting, providing patient comfort, increasing evidence-based nursing knowledge and increasing the quality of care.
Read the detailed description
Postoperative nausea and vomiting (POBK) according to ASPAN (American Society of PeriAnesthesia Nurses) are Nausea and vomiting seen in the first 24 hours after surgery (1). While PONV is seen in 20-30% of patients after general anesthesia, this rate increases up to 80% in high-risk patients (2). PONV, which is the second most common postoperative complaint after pain, is a stressful and uncomfortable situation for patients, but it can cause serious complications. These complications are; dehydration, electrolyte imbalance, acid-base imbalance, pulmonary aspiration, pneumothorax, hypoxia, esophageal rupture, increased intracranial pressure, suture rupture, bleeding (3). Due to the long duration of general anesthesia and the use of high-dose opioids, the incidence of PONV is higher in some types of surgery (eg, abdominal surgeries) (4). Recent studies have shown that laparoscopic, gynecological and cholecystectomy surgeries are high-risk surgeries in terms of PONV (5).
While obesity ranks second among the preventable causes of death in the world, bariatric surgery is seen as the most effective method in the treatment of morbid obesity (6). Bariatric surgeries are surgeries that carry a high risk in terms of PONC, since they are abdominal surgery, performed under general anesthesia, and the laparoscopic method is preferred. Antiemetics can be used in high-risk patients after risk factors are determined to prevent PONV. However, due to complications, the effectiveness of the use of antiemetic drugs in the management of PONC remains limited (7). Published guidelines on PONC management recommend the use of non-pharmacological methods in addition to pharmacological treatment in patients at high risk for PONV. Some of the complementary methods used to prevent PONV are acupuncture, aromatherapy, acupressure, progressive relaxation exercises, hypnosis, massage, and music therapy (7). It has been reported in the literature that music therapy is a non-pharmacological nursing practice that is used to manage nausea-vomiting and the severity of symptoms, has no side effects, is easy to use (8). In addition, it has been noted that music therapy has positive effects on analgesic requirement, hospital stay, reducing fatigue and the use of antiemetic drugs (8). Çetinkaya's study to determine the effect of music on the severity of postoperative nausea and vomiting after laparoscopic cholecystectomy showed that listening to music reduces the severity of nausea and the frequency of nausea (9). According to a randomized controlled study conducted by Madson and Silverman in a group of 58 solid organ transplant patients, less nausea and vomiting were found in the music therapy group (10). In a study conducted by Nilsson et al. on hysterectomy patients who underwent general anesthesia in the intraoperative period, it was observed that music did not affect nausea and vomiting (11). In another study by Laurion and Fetzer, it was reported that music had no effect on PONV (12). In the fourth consensus guideline on the treatment of postoperative nausea and vomiting, it has been reported that music is not an effective prophylactic method for PONV, but this information is based on a single randomized controlled study (12,13). When the literature is examined, it has been determined that there is no common view on the use of music therapy as a complementary method in the management of PONV and more studies should be done on this subject.
- Conditions
- Bariatric Surgery
- Being tested
- Music Therapy
- Keywords
- bariatric surgery, music therapy, nausea and vomiting, postoperative, nursing care
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
Huseyni maqam, Pentatonic music
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Active comparator | 30 Minutes before evaluate PONV at 2nd,4th,6th,12th,24th hours Receives: Behavioral: Music Therapy |
| No Intervention | No intervention | No intervention performed PONV evaluated at 2nd,4th,6th,12th,24th hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Measured: Postoperative 2nd hour
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are not much, sometimes, often or often, always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines clinically significant nausea and vomiting.
Measured: Postoperative 4th hour
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are not much, sometimes, often or often, always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines clinically significant nausea and vomiting.
Measured: Postoperative 6th hour
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are not much, sometimes, often or often, always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines clinically significant nausea and vomiting.
Measured: Postoperative 12th hour
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are not much, sometimes, often or often, always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines clinically significant nausea and vomiting.
Measured: Postoperative 24th hour
Secondary outcomes (1)
Participant's satisfaction with the nursing care with
Numerical Rating scale consisting of numbers between "0" and "10" (0: not at all satisfied 10: very satisfied) have been used to determine the satisfaction level of patients at the 24th postoperative hour.
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 May 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Model description
- Intervention and Non Intervention Group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Yilmaz Sahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibel Yilmaz Sahin, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Sibel YILMAZ SAHIN, Asst.Prof., Principal investigator, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048952
- Sponsor's protocol ID
- BSMusicPONV
- Acronym
- BSMusicPONV
- Status last verified
- Dec 2023
- First submitted
- 12 Jan 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatrik Cerrahi Sonrası Müzik Terapinin Postoperatif Bulantı Kusmayı Azaltma ve Hasta Memnuniyeti Üzerine Etkisi
- ClinicalTrials.gov ID
- NCT06048952
- Acronym / sponsor ID
- BSMusicPONV / BSMusicPONV
- Conditions
- Bariatric Surgery
- Keywords
- bariatric surgery, music therapy, nausea and vomiting, postoperative, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sibel Yilmaz SahinUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 21 Sep 2023 (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.
In this study, it was planned to evaluate the effectiveness of the use of music therapy, which is a non-pharmacological method, in addition to pharmacological treatment in patients with PONV after bariatric surgery, whose application frequency is increasing in the treatment of obesity, and to determine its effect on patient satisfaction. The findings of this study are considered to be effective in preventing nausea and vomiting, providing patient comfort, increasing evidence-based nursing knowledge and increasing the quality of care.
Detailed description
Postoperative nausea and vomiting (POBK) according to ASPAN (American Society of PeriAnesthesia Nurses) are Nausea and vomiting seen in the first 24 hours after surgery (1). While PONV is seen in 20-30% of patients after general anesthesia, this rate increases up to 80% in high-risk patients (2). PONV, which is the second most common postoperative complaint after pain, is a stressful and uncomfortable situation for patients, but it can cause serious complications. These complications are; dehydration, electrolyte imbalance, acid-base imbalance, pulmonary aspiration, pneumothorax, hypoxia, esophageal rupture, increased intracranial pressure, suture rupture, bleeding (3). Due to the long duration of general anesthesia and the use of high-dose opioids, the incidence of PONV is higher in some types of surgery (eg, abdominal surgeries) (4). Recent studies have shown that laparoscopic, gynecological and cholecystectomy surgeries are high-risk surgeries in terms of PONV (5).
While obesity ranks second among the preventable causes of death in the world, bariatric surgery is seen as the most effective method in the treatment of morbid obesity (6). Bariatric surgeries are surgeries that carry a high risk in terms of PONC, since they are abdominal surgery, performed under general anesthesia, and the laparoscopic method is preferred. Antiemetics can be used in high-risk patients after risk factors are determined to prevent PONV. However, due to complications, the effectiveness of the use of antiemetic drugs in the management of PONC remains limited (7). Published guidelines on PONC management recommend the use of non-pharmacological methods in addition to pharmacological treatment in patients at high risk for PONV. Some of the complementary methods used to prevent PONV are acupuncture, aromatherapy, acupressure, progressive relaxation exercises, hypnosis, massage, and music therapy (7). It has been reported in the literature that music therapy is a non-pharmacological nursing practice that is used to manage nausea-vomiting and the severity of symptoms, has no side effects, is easy to use (8). In addition, it has been noted that music therapy has positive effects on analgesic requirement, hospital stay, reducing fatigue and the use of antiemetic drugs (8). Çetinkaya's study to determine the effect of music on the severity of postoperative nausea and vomiting after laparoscopic cholecystectomy showed that listening to music reduces the severity of nausea and the frequency of nausea (9). According to a randomized controlled study conducted by Madson and Silverman in a group of 58 solid organ transplant patients, less nausea and vomiting were found in the music therapy group (10). In a study conducted by Nilsson et al. on hysterectomy patients who underwent general anesthesia in the intraoperative period, it was observed that music did not affect nausea and vomiting (11). In another study by Laurion and Fetzer, it was reported that music had no effect on PONV (12). In the fourth consensus guideline on the treatment of postoperative nausea and vomiting, it has been reported that music is not an effective prophylactic method for PONV, but this information is based on a single randomized controlled study (12,13). When the literature is examined, it has been determined that there is no common view on the use of music therapy as a complementary method in the management of PONV and more studies should be done on this subject.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and Non Intervention Group
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Active comparator | Behavioral: Music Therapy30 Minutes before evaluate PONV at 2nd,4th,6th,12th,24th hours |
| No Intervention | No intervention | –No intervention performed PONV evaluated at 2nd,4th,6th,12th,24th hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cognitive functions are sufficient,
- Able to communicate in Turkish,
- Between the ages of 18-80,
- Patients who voluntarily participated in the study
Key exclusion criteria (3 listed)
- Patients who did not volunteer for the study,
- Patients who underwent open surgery
- whose mother tongue is not Turkish
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 TherapyHuseyni maqam, Pentatonic music | Behavioural | Music Therapy |
Primary outcome
Postoperative Nausea and Vomiting
Time frame: Postoperative 2nd hour
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Postoperative Nausea and Vomiting
Time frame: Postoperative 4th hour
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are not much, sometimes, often or often, always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines clinically significant nausea and vomiting.
Postoperative Nausea and Vomiting
Time frame: Postoperative 6th hour
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are not much, sometimes, often or often, always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines clinically significant nausea and vomiting.
Postoperative Nausea and Vomiting
Time frame: Postoperative 12th hour
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are not much, sometimes, often or often, always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines clinically significant nausea and vomiting.
Postoperative Nausea and Vomiting
Time frame: Postoperative 24th hour
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are not much, sometimes, often or often, always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines clinically significant nausea and vomiting.
1 secondary outcome
Participant's satisfaction with the nursing care with
Time frame: Postoperative 24th 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 15 Dec 2023.
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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.
Sibel YILMAZ SAHIN, Asst.Prof. principal investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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 Bariatric Surgery, run by Sibel Yilmaz Sahin at 1 site in Turkey (Türkiye).
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 3 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 15 Dec 2023. 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 Turkey (Türkiye). 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?
Postoperative Nausea and Vomiting (time frame: Postoperative 2nd hour). The study lists 5 primary outcomes in all. 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 15 Dec 2023.