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The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level.

Primary Purpose

General Surgery, Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
comedy movie group
Sponsored by
Gurkan KAPIKIRAN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for General Surgery focused on measuring Abdominal Surgery, Preoperative Anxiety, Comedy Film, Postoperative Pain

Eligibility Criteria

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

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,

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

comedy movie group

No treatment group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain level
It is a measure of pain level. Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
Anxiety Level
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.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2022
Last Updated
July 14, 2022
Sponsor
Gurkan KAPIKIRAN
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1. Study Identification

Unique Protocol Identification Number
NCT05424991
Brief Title
The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level.
Official Title
The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level in Abdominal Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gurkan KAPIKIRAN

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Surgery, Anxiety, Pain
Keywords
Abdominal Surgery, Preoperative Anxiety, Comedy Film, Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was conducted as a randomized controlled trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comedy movie group
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
comedy movie group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level
Description
It is a measure of pain level. Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
Time Frame
Time Frame: 0-20 minutes
Title
Anxiety Level
Description
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.
Time Frame
0-20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can reach and get information by e-mail.

Learn more about this trial

The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level.

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