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The Effect of Turkish Music and Comedy Film on Pain, Vital Signs and Cortisol Level in Orthopedic Patients

Primary Purpose

Physiological Parameter, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Turkish Music
comedy movie
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Physiological Parameter focused on measuring Saliva cortisol, Pain, Funny Film, Türkish Müsic, Nursing, Vital signs

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Those with pain score below 4
  • Those who have recently used analgesic medication
  • Those who have recently consumed any food or drink

Sites / Locations

  • İnonu Ünıversty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Turkish Music Group

Comedy Film Group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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 ".

Secondary Outcome Measures

Full Information

First Posted
February 4, 2021
Last Updated
April 4, 2022
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04755114
Brief Title
The Effect of Turkish Music and Comedy Film on Pain, Vital Signs and Cortisol Level in Orthopedic Patients
Official Title
İnönü University Faculty of Nursing Lecturer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 3, 2022 (Actual)
Study Completion Date
February 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiological Parameter, Acute Pain
Keywords
Saliva cortisol, Pain, Funny Film, Türkish Müsic, Nursing, Vital signs

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Turkish Music Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Comedy Film Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Turkish Music
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
comedy movie
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS)
Description
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 ".
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Those with pain score below 4 Those who have recently used analgesic medication Those who have recently consumed any food or drink
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice OLTULUOĞLU
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
İnonu Ünıversty
City
Malatya
ZIP/Postal Code
44100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31785131/
Description
references

Learn more about this trial

The Effect of Turkish Music and Comedy Film on Pain, Vital Signs and Cortisol Level in Orthopedic Patients

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