General SurgeryNCT05424991
The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level.
A study testing comedy movie group in people with General Surgery and Anxiety, run by Gurkan KAPIKIRAN at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Surgery, Anxiety, Pain
- What is being tested?
- comedy movie group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2021to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- with a communication barrier,
- Having an uncontrollable psychiatric disorder,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- General Surgery, Anxiety, Pain
- Being tested
- comedy movie group
- Keywords
- Abdominal Surgery, Preoperative Anxiety, Comedy Film, Postoperative Pain
- Medical subject headings
- Anxiety Disorders, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comedy movie groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
It is a measure of pain level. Pain intensity ranges from 0 to 10, 0 points no pain, 10 points unbearable pain.
Measured: 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.
Measured: 0-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start5 Oct 2021
- Primary completion5 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as a randomized controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gurkan KAPIKIRAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gurkan KAPIKIRAN, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424991
- Sponsor's protocol ID
- 2021/179
- Status last verified
- Jul 2022
- First submitted
- 15 Jun 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers can reach and get information by e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level in Abdominal Surgery Patients
- ClinicalTrials.gov ID
- NCT05424991
- Acronym / sponsor ID
- 2021/179
- Conditions
- General Surgery, Anxiety, Pain
- Keywords
- Abdominal Surgery, Preoperative Anxiety, Comedy Film, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Gurkan KAPIKIRANUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was conducted as a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| comedy movie group | Experimental | Behavioral: comedy movie groupThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- with a communication barrier,
- Having an uncontrollable psychiatric disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comedy movie groupThe 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. | Behavioural | comedy movie group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No. Other researchers can reach and get information by e-mail.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comedy movie group in people with General Surgery and Anxiety, run by Gurkan KAPIKIRAN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Time Frame: 0-20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.