Physiological ParameterNCT04755114
The Effect of Turkish Music and Comedy Film on Pain, Vital Signs and Cortisol Level in Orthopedic Patients
A study testing Turkish Music and comedy movie in people with Physiological Parameter and Acute Pain, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this thesis is; It was planned to determine the effect of Turkish music and comedy films on pain, vital signs and cortisol levels of patients who had orthopedic surgery. The research is a randomized controlled study. 132 patients who meet the research conditions will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Parameter, Acute Pain
- What is being tested?
- Turkish Music and comedy movie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 3 Feb 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Does not have any communication problem that will prevent him from understanding the information given, listening to music, watching movies and expressing the pain level correctly,
- Expressing that he experienced "moderate" or "severe" (4 and above according to the Numerical Rating Scale-SDS) pain after the operation,
- Having been operated under general anesthesia and 24 hours after surgery,
- No complications (severe bleeding, nausea, vomiting, etc.) developed in the early postoperative period,
- Without a chronic cardiovascular and respiratory system disease and hormonal problems
- Patients not receiving steroid therapy will be included in the study.
Who cannot join
- Those with pain score below 4
- Those who have recently used analgesic medication
- Those who have recently consumed any food or drink
Trial locations and contacts
1 site in 1 country.
About this study
Official title: İnönü University Faculty of Nursing Lecturer
The aim of this thesis is; It was planned to determine the effect of Turkish music and comedy films on pain, vital signs and cortisol levels of patients who had orthopedic surgery.
The research is a randomized controlled study. 132 patients who meet the research conditions will be included in the study. Patient Information Form, Numerical Pain Rating Scale, Physiological Parameter Form developed by the researcher will be used for data collection.
Read the detailed description
Turkish Music and Comedy Film Group Data Collection After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Immediately after the pre-test evaluations, the music group will be played to the music desired by the patient for 30 minutes, and the comedy film group will be shown a comedy movie video. Immediately after the interventions, pain level, vital signs will be evaluated and saliva sample will be taken as a final test (30 minutes). The same procedures will be repeated in the 60th minute after the intervention to determine the duration of the interventions applied.
Control group Data Collection After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min).
Pain level and vital signs will be evaluated and saliva sample will be taken for the final test (30th minute) and follow-up (60th minute) simultaneously with the administration group without any intervention.
Collection of Saliva Samples Salivary cortisol is free cortisol not bound to plasma proteins. Considering that the active cortisol is free cortisol, many studies have used the measurement of cortisol in saliva. In addition, salivary cortisol measurement is considered to be a reliable method for measuring stress, since it can be easily obtained, it does not cause stress because it is not invasive, and it shows strong correlation between plasma cortisol levels.
The concentration of cortisol is at its maximum shortly after waking up in the morning, depending on the circadian rhythm. It then declines gradually throughout the day and reaches its lowest level at night. Salivary cortisol also matches the 24-hour rhythm of plasma cortisol.
Saliva samples will be taken at least one hour after the patients wake up so that the circadian changes in cortisol do not affect the results. In order not to change the cortisol levels, the patients will be informed that they should not take orally, chew any substance such as chewing gum, brush teeth, gargle, or smoke one hour after breakfast. It is recommended to rinse the patient's mouth thoroughly with water for 30 seconds before saliva sampling.
To collect saliva sample; Saliva collection tubes were prepared separately for all measurements. Colored labels were affixed on 1.5 ml eppendorf tubes prepared for each measurement of all groups.
Red labels were affixed to the tube of the Turkish music group, green to the tube of the Konedi movie group, and white to the tube of the control group. Numbers given to the participant and the number of measurements (a = 0 minutes, b = 30 minutes, c = 60 minutes) were written on colored labels. In order to facilitate the salivation process, the participants will be given a hookah mouthpiece (sipsi). Saliva collection will be done using passive flow method.
Saliva samples will be stored in the freezer at -20 ° C in the laboratory of the Faculty of Health Sciences, while preserving the cold chain.
- Conditions
- Physiological Parameter, Acute Pain
- Being tested
- Turkish Music, comedy movie
- Keywords
- Saliva cortisol, Pain, Funny Film, Türkish Müsic, Nursing, Vital signs
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish MusicOther
Turkish Music;In choosing the music, patients will be asked about their favorite vocalist and music pieces before the procedure. The researcher will then download these music pieces from YouTube and create a 30-minute list and listen to patients.
comedy movieOther
Prior to the research, attention will be paid to the selection of comedy films that do not contain violence, swearing and obscene scenes that may adversely affect patients. Prior to the research, attention will be paid to the selection of comedy films that do not contain violence, swearing and obscene scenes that may adversely affect patients. In the selection of comedy films, the opinions of two experts from Mimar Sinan University, Faculty of Fine Arts, Department of Cinema and Television and İnönü University will be preferred, and the films Kemal Sunal and Şener Şen, one of the actors that Turkish people know closely, laugh most and have settled into their culture, will be preferred.
| Study group | Role | What they receive |
|---|---|---|
| Turkish Music Group | Experimental | After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Immediately after the pre-test evaluations, the music group will be played to the music desired by the patient for 30 minutes. Immediately after the interventions, pain level, vital signs will be evaluated and saliva sample will be taken as a final test (30 minutes). The same procedures will be repeated in the 60th minute after the intervention to determine the duration of the interventions applied. Receives: Other: Turkish Music |
| Comedy Film Group | Experimental | fter the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Immediately after the pre-test evaluations,the Comedy film group will watch a comedy movie video. Immediately after the interventions, pain level, vital signs will be evaluated and saliva sample will be taken as a final test (30 minutes). The same procedures will be repeated in the 60th minute after the intervention to determine the duration of the interventions applied. Receives: Other: comedy movie |
| Control group | No intervention | After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Pain level and vital signs will be evaluated and saliva sample will be taken for the final test (30th minute) and follow-up (60th minute) simultaneously with the administration group without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
Each participant has 60 minutes between pretest and posttest. The first follow-up will be done at the first meeting, the second follow-up in the 30th minute, and the last follow-up at the 60th minute.
There are 11 points on this scale with numbers between 0-10. The "0" point on the left indicates "no pain", "the point" 10 "on the right indicates" the worst pain imaginable ".
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Feb 2021
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ParameterStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice OLTULUOĞLU, Inonu University
- Investigators
- Hatice OLTULUOĞLU, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755114
- Sponsor's protocol ID
- İnonuU
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- İnönü University Faculty of Nursing Lecturer
- ClinicalTrials.gov ID
- NCT04755114
- Acronym / sponsor ID
- İnonuU
- Conditions
- Physiological Parameter, Acute Pain
- Keywords
- Saliva cortisol, Pain, Funny Film, Türkish Müsic, Nursing, Vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 15 Feb 2021 (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.
The aim of this thesis is; It was planned to determine the effect of Turkish music and comedy films on pain, vital signs and cortisol levels of patients who had orthopedic surgery.
The research is a randomized controlled study. 132 patients who meet the research conditions will be included in the study. Patient Information Form, Numerical Pain Rating Scale, Physiological Parameter Form developed by the researcher will be used for data collection.
Detailed description
Turkish Music and Comedy Film Group Data Collection After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Immediately after the pre-test evaluations, the music group will be played to the music desired by the patient for 30 minutes, and the comedy film group will be shown a comedy movie video. Immediately after the interventions, pain level, vital signs will be evaluated and saliva sample will be taken as a final test (30 minutes). The same procedures will be repeated in the 60th minute after the intervention to determine the duration of the interventions applied.
Control group Data Collection After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min).
Pain level and vital signs will be evaluated and saliva sample will be taken for the final test (30th minute) and follow-up (60th minute) simultaneously with the administration group without any intervention.
Collection of Saliva Samples Salivary cortisol is free cortisol not bound to plasma proteins. Considering that the active cortisol is free cortisol, many studies have used the measurement of cortisol in saliva. In addition, salivary cortisol measurement is considered to be a reliable method for measuring stress, since it can be easily obtained, it does not cause stress because it is not invasive, and it shows strong correlation between plasma cortisol levels.
The concentration of cortisol is at its maximum shortly after waking up in the morning, depending on the circadian rhythm. It then declines gradually throughout the day and reaches its lowest level at night. Salivary cortisol also matches the 24-hour rhythm of plasma cortisol.
Saliva samples will be taken at least one hour after the patients wake up so that the circadian changes in cortisol do not affect the results. In order not to change the cortisol levels, the patients will be informed that they should not take orally, chew any substance such as chewing gum, brush teeth, gargle, or smoke one hour after breakfast. It is recommended to rinse the patient's mouth thoroughly with water for 30 seconds before saliva sampling.
To collect saliva sample; Saliva collection tubes were prepared separately for all measurements. Colored labels were affixed on 1.5 ml eppendorf tubes prepared for each measurement of all groups.
Red labels were affixed to the tube of the Turkish music group, green to the tube of the Konedi movie group, and white to the tube of the control group. Numbers given to the participant and the number of measurements (a = 0 minutes, b = 30 minutes, c = 60 minutes) were written on colored labels. In order to facilitate the salivation process, the participants will be given a hookah mouthpiece (sipsi). Saliva collection will be done using passive flow method.
Saliva samples will be stored in the freezer at -20 ° C in the laboratory of the Faculty of Health Sciences, while preserving the cold chain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Turkish Music Group | Experimental | Other: Turkish MusicAfter the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Immediately after the pre-test evaluations, the music group will be played to the music desired by the patient for 30 minutes. Immediately after the interventions, pain level, vital signs will be evaluated and saliva sample will be taken as a final test (30 minutes). The same procedures will be repeated in the 60th minute after the intervention to determine the duration of the interventions applied. |
| Comedy Film Group | Experimental | Other: comedy moviefter the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Immediately after the pre-test evaluations,the Comedy film group will watch a comedy movie video. Immediately after the interventions, pain level, vital signs will be evaluated and saliva sample will be taken as a final test (30 minutes). The same procedures will be repeated in the 60th minute after the intervention to determine the duration of the interventions applied. |
| Control group | No intervention | –After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Pain level and vital signs will be evaluated and saliva sample will be taken for the final test (30th minute) and follow-up (60th minute) simultaneously with the administration group without any intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Does not have any communication problem that will prevent him from understanding the information given, listening to music, watching movies and expressing the pain level correctly,
- Expressing that he experienced "moderate" or "severe" (4 and above according to the Numerical Rating Scale-SDS) pain after the operation,
- Having been operated under general anesthesia and 24 hours after surgery,
- No complications (severe bleeding, nausea, vomiting, etc.) developed in the early postoperative period,
- Without a chronic cardiovascular and respiratory system disease and hormonal problems
Key exclusion criteria (3 listed)
- Those with pain score below 4
- Those who have recently used analgesic medication
- Those who have recently consumed any food or drink
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 |
|---|---|---|
| Turkish MusicTurkish Music;In choosing the music, patients will be asked about their favorite vocalist and music pieces before the procedure. The researcher will then download these music pieces from YouTube and create a 30-minute list and listen to patients. | Other | Turkish Music Group |
| comedy moviePrior to the research, attention will be paid to the selection of comedy films that do not contain violence, swearing and obscene scenes that may adversely affect patients. Prior to the research, attention will be paid to the selection of comedy films that do not contain violence, swearing and obscene scenes that may adversely affect patients. In the selection of comedy films, the opinions of two experts from Mimar Sinan University, Faculty of Fine Arts, Department of Cinema and Television and İnönü University will be preferred, and the films Kemal Sunal and Şener Şen, one of the actors that Turkish people know closely, laugh most and have settled into their culture, will be preferred. | Other | Comedy Film Group |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: 5 months
Each participant has 60 minutes between pretest and posttest. The first follow-up will be done at the first meeting, the second follow-up in the 30th minute, and the last follow-up at the 60th minute. There are 11 points on this scale with numbers between 0-10. The "0" point on the left indicates "no pain", "the point" 10 "on the right indicates" the worst pain imaginable ".
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 Apr 2022.
- referencesLink provided by the sponsor.
- 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.
Hatice OLTULUOĞLU principal investigator
Inonu 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 Turkish Music and comedy movie in people with Physiological Parameter and Acute Pain, run by Inonu 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 6 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 5 Apr 2022. 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?
Numerical Pain Rating Scale (NPRS) (time frame: 5 months). 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 5 Apr 2022.