Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755114
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2021-02-04
Brief Title:
The Effect of Turkish Music and Comedy Film on Pain Vital Signs and Cortisol Level in Orthopedic Patients
Sponsor:
Inonu University
Organization:
Inonu University
Study Overview
Official Title:
İnönü University Faculty of Nursing Lecturer
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Patient Information Form Numerical Pain Rating Scale Physiological Parameter Form developed by the researcher will be used for data collection
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 patients 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 15 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
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 patients 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 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None