NCT05424991

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

October 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

June 15, 2022

Last Update Submit

July 14, 2022

Conditions

Keywords

Abdominal SurgeryPreoperative AnxietyComedy FilmPostoperative Pain

Outcome Measures

Primary Outcomes (2)

  • Pain level

    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

    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.

    0-20 minutes

Study Arms (2)

comedy movie group

EXPERIMENTAL

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.

Behavioral: comedy movie group

No treatment group

NO INTERVENTION

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.

Interventions

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.

comedy movie group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • with a communication barrier,
  • Having an uncontrollable psychiatric disorder,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPainPain, Postoperative

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was conducted as a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

October 5, 2021

Primary Completion

June 5, 2022

Study Completion

June 22, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Other researchers can reach and get information by e-mail.

Locations