InfertilityNCT03346031
The Effect of Music Therapy on Analgesia and Oxidative Stress Parameters
A study testing music therapy in people with Infertility and Anesthesia, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Music has been used in the treatment of patient since the time Plato, Hippocrates and Alpharabius were alive. It is used by music therapists to help patients' social, physical, emotional, psychological and spiritual needs. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Anesthesia
- What is being tested?
- music therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2017to 1 Jun 2018
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1.Voluntary patients
- patients without hearing problems
- patients between the ages of 18 and 40
- patients without music phobia
Who cannot join
- Patients with hearing problems.
- Patients older than 18 years and older than 40 years
- Patients who do not want to participate in the trial
- Patients with music phobia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, Onikişubat, 251/A 46040
About this study
Official title: Assessment of the Effect of Music Therapy on Analgesia and Oxidative Stress Parameters in Anesthetized Oocyt Pickup Patients
Music has been used in the treatment of patient since the time Plato, Hippocrates and Alpharabius were alive. It is used by music therapists to help patients' social, physical, emotional, psychological and spiritual needs. In a study conducted, it was seen that music has a positive effect on pain, anxiety, depression, shortness of breath, mood, face expression and speech. Our aim is to evaluate the analgesic consumption of music therapy during egg collection applications and to compare the parameters of oxidative stress in blood and follicular fluid.
Read the detailed description
Patients were randomly allocated into 3 groups. Group 1 is control group. Group 2 is Classical Turkish Music group. Group 3 will be organized as a group listening continuously (Preoperative and peroperative) Classical Turkish Music (Acemaşiran Makam). Voluntary patients, patients without hearing problems, patients between the ages of 18 and 40, and patients without music phobia will be included in the study. Patients who do not want to participate in the study, patients with hearing problems, and patients outside the 18-40 age range will not be included in the study. Once the Control group has been taken to the patient's room, the vessel way will be prepared for operation and will be kept waiting for one hour. Then blood will be taken to evaluate the oxidative stress parameters (Superoxide Dysmotase, Catalase, Glutathione Peroxidase, Myeloperoxidase, Malondialdehyde, Nitric Oxide, Thiol Disulfide levels) and taken to the operation room. Group 2 patients will be taken to the patient's rest room and will listen to music with an MP3 headset for 1 hour. Patient's blood will be taken to assess the oxidative stress parameters and taken to the operation room. Group 3 will listen Turkish Classical Music for 1 hour in patient room, vein path will be opened, Patient's blood will be taken with the aim of evaluating oxidative stress parameters and taken to the operation room. The patients will listen to music throughout the operation. All patients included in the study (Gr.1, Gr.2, Gr.3 patients) will use remifentanil 0.5 mcg / kg, propofol 1 mg / kg on induction after taken to the operating table. Hemodynamics (Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Oxygen Saturation, Mean arterial pressure) and body movements of all patients included in the study will be recorded. Additional anesthesia and analgesia needs will be recorded during the operation at 1,3,5,7,10,15 minutes. Blood and follicle fluid will be taken with the aim of comparing the values of Oxidative Stress Parameters in blood and follicular fluid at the end of the operation of all the patients in the three groups included in the study. Hemodynamics follow-up and pain follow-ups will be recorded at 1,5,15,30, and 60 minutes in the postoperative resting rooms of the patients after the operation. VAS will be used for pain recording. The analgesic needs of the patients will be met. Non-steroidal anti-inflammatory drugs will be administered to patients for postoperative analgesia. The pre-and post-operative oxidative stress parameters in patients blood will be compared and the oxidative stress parameter values of the follicular fluid of the patients after the operation will be compared in the three groups.
- Conditions
- Infertility, Anesthesia
- Being tested
- music therapy
- Keywords
- music therapy, pain, oxidative stress parameters
- Medical subject headings
- Infertility, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyProcedure or surgery
patients will listen to music with an MP3 headset
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Group 1 is control group that does not listen to music |
| Music Therapy Group 2 | Active comparator | Group 2 is the group listening to preoperative music Receives: Procedure: music therapy |
| Music Therapy Group 3 | Active comparator | Group 3 is the preoperative and peroperative music listening group (continuous) Receives: Procedure: music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress markers with the music therapy
To evaluate the impact on the circulating levels of Catalase ü/ml,Glutathione Peroxidase ü/ml, Myeloperoxidase ü/ml, Malondialdehyde nmol/ ml, Nitric Oxide umol/ L, Thiol Disulfide
Measured: Change from baseline at 1 hour
Secondary outcomes (3)
Pain Scores
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Measured: 1 minute,5 minute,15 minute,30 minute, 60 minute of pain level after operation
Hemodynamics and oxygen follow-up
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate,
Measured: During the operation, 1 minute, 3 minutes, 5 minutes, 7 minutes, 10 minutes, 15 minutes.Each unit will be evaluated separately within itself
Hemodynamics and oxygen follow-up
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate,
Measured: after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Oct 2017
- Primary completion1 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Orak, Kahramanmaras Sutcu Imam University
- Investigators
- yavuz orak, md, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346031
- Sponsor's protocol ID
- 2017/12-14
- Status last verified
- Jul 2018
- First submitted
- 7 Nov 2017
- Last updated
- 11 Mar 2019
- 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 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Music Therapy on Analgesia and Oxidative Stress Parameters in Anesthetized Oocyt Pickup Patients
- ClinicalTrials.gov ID
- NCT03346031
- Acronym / sponsor ID
- 2017/12-14
- Conditions
- Infertility, Anesthesia
- Keywords
- music therapy, pain, oxidative stress parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 17 Nov 2017 (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.
Music has been used in the treatment of patient since the time Plato, Hippocrates and Alpharabius were alive. It is used by music therapists to help patients' social, physical, emotional, psychological and spiritual needs. In a study conducted, it was seen that music has a positive effect on pain, anxiety, depression, shortness of breath, mood, face expression and speech. Our aim is to evaluate the analgesic consumption of music therapy during egg collection applications and to compare the parameters of oxidative stress in blood and follicular fluid.
Detailed description
Patients were randomly allocated into 3 groups. Group 1 is control group. Group 2 is Classical Turkish Music group. Group 3 will be organized as a group listening continuously (Preoperative and peroperative) Classical Turkish Music (Acemaşiran Makam). Voluntary patients, patients without hearing problems, patients between the ages of 18 and 40, and patients without music phobia will be included in the study. Patients who do not want to participate in the study, patients with hearing problems, and patients outside the 18-40 age range will not be included in the study. Once the Control group has been taken to the patient's room, the vessel way will be prepared for operation and will be kept waiting for one hour. Then blood will be taken to evaluate the oxidative stress parameters (Superoxide Dysmotase, Catalase, Glutathione Peroxidase, Myeloperoxidase, Malondialdehyde, Nitric Oxide, Thiol Disulfide levels) and taken to the operation room. Group 2 patients will be taken to the patient's rest room and will listen to music with an MP3 headset for 1 hour. Patient's blood will be taken to assess the oxidative stress parameters and taken to the operation room. Group 3 will listen Turkish Classical Music for 1 hour in patient room, vein path will be opened, Patient's blood will be taken with the aim of evaluating oxidative stress parameters and taken to the operation room. The patients will listen to music throughout the operation. All patients included in the study (Gr.1, Gr.2, Gr.3 patients) will use remifentanil 0.5 mcg / kg, propofol 1 mg / kg on induction after taken to the operating table. Hemodynamics (Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Oxygen Saturation, Mean arterial pressure) and body movements of all patients included in the study will be recorded. Additional anesthesia and analgesia needs will be recorded during the operation at 1,3,5,7,10,15 minutes. Blood and follicle fluid will be taken with the aim of comparing the values of Oxidative Stress Parameters in blood and follicular fluid at the end of the operation of all the patients in the three groups included in the study. Hemodynamics follow-up and pain follow-ups will be recorded at 1,5,15,30, and 60 minutes in the postoperative resting rooms of the patients after the operation. VAS will be used for pain recording. The analgesic needs of the patients will be met. Non-steroidal anti-inflammatory drugs will be administered to patients for postoperative analgesia. The pre-and post-operative oxidative stress parameters in patients blood will be compared and the oxidative stress parameter values of the follicular fluid of the patients after the operation will be compared in the three groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Group 1 is control group that does not listen to music |
| Music Therapy Group 2 | Active comparator | Procedure: music therapyGroup 2 is the group listening to preoperative music |
| Music Therapy Group 3 | Active comparator | Procedure: music therapyGroup 3 is the preoperative and peroperative music listening group (continuous) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1.Voluntary patients
- patients without hearing problems
- patients between the ages of 18 and 40
- patients without music phobia
Key exclusion criteria (4 listed)
- Patients with hearing problems.
- Patients older than 18 years and older than 40 years
- Patients who do not want to participate in the trial
- Patients with music phobia
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 will listen to music with an MP3 headset | Procedure or surgery | Music Therapy Group 2, Music Therapy Group 3 |
Primary outcome
Oxidative stress markers with the music therapy
Time frame: Change from baseline at 1 hour
To evaluate the impact on the circulating levels of Catalase ü/ml,Glutathione Peroxidase ü/ml, Myeloperoxidase ü/ml, Malondialdehyde nmol/ ml, Nitric Oxide umol/ L, Thiol Disulfide
3 secondary outcomes
Pain Scores
Time frame: 1 minute,5 minute,15 minute,30 minute, 60 minute of pain level after operation
Hemodynamics and oxygen follow-up
Time frame: During the operation, 1 minute, 3 minutes, 5 minutes, 7 minutes, 10 minutes, 15 minutes.Each unit will be evaluated separately within itself
Hemodynamics and oxygen follow-up
Time frame: after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
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 11 Mar 2019.
- 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.
yavuz orak, md principal investigator
Kahramanmaras Sutcu Imam 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 therapy in people with Infertility and Anesthesia, run by Kahramanmaras Sutcu Imam University 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 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 11 Mar 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 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?
Oxidative stress markers with the music therapy (time frame: Change from baseline at 1 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 11 Mar 2019.