NCT04755114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

February 4, 2021

Last Update Submit

April 4, 2022

Conditions

Keywords

Saliva cortisolPainFunny FilmTürkish MüsicNursingVital signs

Outcome Measures

Primary Outcomes (1)

  • 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 ".

    5 months

Study Arms (3)

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.

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.

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.

Interventions

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.

Turkish Music Group

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.

Comedy Film Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İnonu Ünıversty

Malatya, 44100, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Acute PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hatice OLTULUOĞLU

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 15, 2021

Study Start

February 1, 2021

Primary Completion

February 3, 2022

Study Completion

February 3, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations