- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05424991
The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level.
July 14, 2022 updated by: Gurkan KAPIKIRAN
The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level in Abdominal Surgery Patients
When we look at the literature, studies examining the effect of having patients watch comedy films on anxiety and pain are limited.
However, it was observed that the anxiety and pain levels of oncology patients who underwent surgery decreased by watching comedy movies.
Therefore, in order to use the healing effects of humor, our study was planned to determine the effect of watching comedy films on the level of anxiety and postoperative pain in patients undergoing abdominal surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Whether it is major surgery or minor surgery, preoperative anxiety is observed in all patients in the preoperative period.
A high level of anxiety causes many physiological and psychological problems in the body and causes an increase in sympathetic and endocrine system stimuli.
Among the physiological and psychological problems seen, many conditions such as recovery time, quality of life, health care expenditures, vital signs and well-being are negatively affected.
Therefore, many applications can be used to reduce the level of anxiety before surgery.
With humor, which is one of them, the anxiety levels of the patients can be reduced and they can manage their stress management better.
In addition to reducing the level of anxiety before the operation, the experience of post-operative pain is one of the important problems experienced by the patients.
Pain complaints are a general problem in the postoperative period in abdominal surgeries.
The usefulness of using supportive complementary and alternative therapies in addition to pharmacological treatments in postoperative pain management is emphasized in the literature.
Among these non-pharmacological treatments, it is stated that humor and laughter increase tolerance to pain and have positive effects on mood.
Humor and laughter not only increase pain tolerance, but also reduce fear, anxiety and anger, and help lower the level of anxiety.
Therefore, in order to use the healing effects of humor, our study was planned to determine the effect of watching comedy films on the level of anxiety and postoperative pain in patients undergoing abdominal surgery.
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Malatya, Turkey, 44100
- Inonu University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years and over,
- Defining the postoperative pain intensity of 4 and above,
- No cognitive problem
- Willing to participate in the research
- Having had Abdominal Surgery.
Exclusion Criteria:
- with a communication barrier,
- Having an uncontrollable psychiatric disorder,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: comedy movie group
The anxiety level of the patients in the experimental group was measured.
Afterwards, each patient watched a comedy movie for 25 minutes.
Anxiety levels were re-measured 25 minutes after watching the comedy movie.
Pain levels were measured after the anesthesia effect disappeared in the postoperative period.
Afterwards, each patient watched a comedy movie for 25 minutes.
Pain levels were re-measured 25 minutes after watching the comedy movie.
|
The patients watched the collage videos of Turkish cinema Yeşilçam comedy films created by the researchers for 25 minutes.
The videos were created by making collages from videos on youtube.
|
|
No Intervention: No treatment group
In the follow-up of the patient, no application was made other than clinical protocols.
Anxiety scale was filled preoperatively, and anxiety level was evaluated again 25 minutes later.
Pain level was evaluated in the postoperative period.
Pain levels were evaluated again at the end of the same period with the experimental group without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain level
Time Frame: Time Frame: 0-20 minutes
|
It is a measure of pain level.
Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
|
Time Frame: 0-20 minutes
|
|
Anxiety Level
Time Frame: 0-20 minutes
|
The state anxiety scale is a 4-point Likert type measurement tool consisting of 20 questions.
The items of the scale that are positive and increase the total anxiety score; Items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18.
The items of the scale that are negative and decrease the total anxiety level; Articles 1, 2, 5, 8, 10, 11, 15, 16, 19, 20.
While evaluating, positive items are calculated as 1,2,3,4 points.
Negative items are calculated as -1, -2, -3, -4 points.
A 50 point constant is added to the obtained scores, and an average score between 20-80 points is obtained.
The higher the total anxiety score, the higher the anxiety level.
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0-20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2021
Primary Completion (Actual)
June 5, 2022
Study Completion (Actual)
June 22, 2022
Study Registration Dates
First Submitted
June 15, 2022
First Submitted That Met QC Criteria
June 15, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Actual)
July 18, 2022
Last Update Submitted That Met QC Criteria
July 14, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Other researchers can reach and get information by e-mail.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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