Preoperative AnxietyNCT07861438
Humor-Based Video Intervention on Preoperative Anxiety Veya Humor Video and Recovery in Cholecystectomy
A study testing Humor-Based Video Intervention and Routine Preoperative Care and Education in people with Preoperative Anxiety and Laparoscopic Cholecystectomy, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate whether watching a short humor-based video before surgery can reduce anxiety and negative emotions and increase positive emotions in patients undergoing elective laparoscopic cholecystectomy (gallbladder removal surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety, Laparoscopic Cholecystectomy
- What is being tested?
- Humor-Based Video Intervention and Routine Preoperative Care and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients undergoing emergency surgery. Patients undergoing a surgical procedure other than elective laparoscopic cholecystectomy.
- Patients with a documented psychiatric disorder that may affect the assessment of anxiety or affective state.
- Patients with cognitive impairment that prevents understanding of the study procedures or completion of the questionnaires.
- Patients with significant hearing or visual impairment that prevents them from watching or hearing the intervention video.
- Patients who have previously participated in the study. Patients who decline to participate or withdraw their informed consent at any stage of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Başakşehir Çam ve Sakura Şehir Hastanesi
Istanbul, Başakşehir
About this study
Official title: The Effect of a Humor-Based Video Intervention on Preoperative Anxiety and Postoperative Quality of Recovery in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This study aims to evaluate whether watching a short humor-based video before surgery can reduce anxiety and negative emotions and increase positive emotions in patients undergoing elective laparoscopic cholecystectomy (gallbladder removal surgery). The study will also examine whether this intervention affects patients' quality of recovery after surgery.
Patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned to either a humor-based video intervention group or a control group. In addition to routine preoperative care and education, patients in the intervention group will watch an approximately 20-minute humor-based video before surgery. Patients in the control group will receive routine preoperative care and education without the humor-based video.
Anxiety, positive and negative emotions, and postoperative quality of recovery will be assessed using standardized questionnaires. The study will compare these outcomes between the two groups to determine whether the humor-based video provides beneficial effects during the perioperative period.
- Conditions
- Preoperative Anxiety, Laparoscopic Cholecystectomy
- Being tested
- Humor-Based Video Intervention, Routine Preoperative Care and Education
- Keywords
- Humor, Humor-Based Video, Laughter, Preoperative Anxiety, State Anxiety, Positive Affect, Negative Affect, Postoperative Recovery, Laparoscopic Cholecystectomy
- Medical subject headings
- Laughter, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humor-Based Video InterventionBehavioural
Also called Humor Video
A single approximately 20-minute humor-based video intervention administered during the preoperative period to patients scheduled for elective laparoscopic cholecystectomy. The video contains humorous and entertaining content designed to divert attention from surgery-related stress, reduce preoperative anxiety and negative affect, and enhance positive affect. The intervention is provided in addition to routine preoperative care and education.
Routine Preoperative Care and EducationBehavioural
Also called Standard Care
Routine preoperative care and education provided according to the standard clinical practice of the general surgery clinic for patients undergoing elective laparoscopic cholecystectomy. This includes usual preoperative information and education provided to patients as part of standard care. No humor-based video intervention is provided to participants in this group.
| Study group | Role | What they receive |
|---|---|---|
| Humor-Based Video Intervention | Experimental | Participants assigned to this group received routine preoperative care and education plus an approximately 20-minute humor-based video intervention before elective laparoscopic cholecystectomy. The video was designed to provide humorous and entertaining content intended to reduce preoperative anxiety and negative affect and enhance positive affect. The intervention was administered once during the preoperative period according to the study protocol. Receives: Behavioral: Humor-Based Video Intervention; Behavioral: Routine Preoperative Care and Education |
| Routine Care and Education | Active comparator | Participants assigned to this group received routine preoperative care and education according to the standard clinical practice of the general surgery clinic. They did not receive the humor-based video intervention during the preoperative period. Receives: Behavioral: Humor-Based Video Intervention; Behavioral: Routine Preoperative Care and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative State Anxiety
Change in preoperative state anxiety measured using the State-Trait Anxiety Inventory-State subscale (STAI-State). Higher scores indicate greater state anxiety.
Measured: Baseline (immediately before the intervention) and immediately after the intervention, before surgery.
Secondary outcomes (3)
Positive Affect
Change in positive affect measured using the Positive and Negative Affect Schedule (PANAS). Higher scores indicate greater positive affect.
Measured: Baseline (immediately before the intervention) and immediately after the intervention, before surgery.
Negative Affect
Change in negative affect measured using the Positive and Negative Affect Schedule (PANAS). Higher scores indicate greater negative affect.
Measured: Baseline (immediately before the intervention) and immediately after the intervention, before surgery.
Postoperative Quality of Recovery
Postoperative quality of recovery measured using the Quality of Recovery-15 (QoR-15) questionnaire. Higher scores indicate better postoperative quality of recovery.
Measured: 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Jun 2026
- Primary completion30 Jul 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Özkan Uğuz, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861438
- Sponsor's protocol ID
- 26-4T/11
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Humor-Based Video Intervention on Preoperative Anxiety and Postoperative Quality of Recovery in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07861438
- Acronym / sponsor ID
- 26-4T/11
- Conditions
- Preoperative Anxiety, Laparoscopic Cholecystectomy
- Keywords
- Humor, Humor-Based Video, Laughter, Preoperative Anxiety, State Anxiety, Positive Affect, Negative Affect, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Oct 2026 (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.
This study aims to evaluate whether watching a short humor-based video before surgery can reduce anxiety and negative emotions and increase positive emotions in patients undergoing elective laparoscopic cholecystectomy (gallbladder removal surgery). The study will also examine whether this intervention affects patients' quality of recovery after surgery.
Patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned to either a humor-based video intervention group or a control group. In addition to routine preoperative care and education, patients in the intervention group will watch an approximately 20-minute humor-based video before surgery. Patients in the control group will receive routine preoperative care and education without the humor-based video.
Anxiety, positive and negative emotions, and postoperative quality of recovery will be assessed using standardized questionnaires. The study will compare these outcomes between the two groups to determine whether the humor-based video provides beneficial effects during the perioperative period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humor-Based Video Intervention | Experimental | Behavioral: Humor-Based Video Intervention, Behavioral: Routine Preoperative Care and EducationParticipants assigned to this group received routine preoperative care and education plus an approximately 20-minute humor-based video intervention before elective laparoscopic cholecystectomy. The video was designed to provide humorous and entertaining content intended to reduce preoperative anxiety and negative affect and enhance positive affect. The intervention was administered once during the preoperative period according to the study protocol. |
| Routine Care and Education | Active comparator | Behavioral: Humor-Based Video Intervention, Behavioral: Routine Preoperative Care and EducationParticipants assigned to this group received routine preoperative care and education according to the standard clinical practice of the general surgery clinic. They did not receive the humor-based video intervention during the preoperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients undergoing emergency surgery. Patients undergoing a surgical procedure other than elective laparoscopic cholecystectomy.
- Patients with a documented psychiatric disorder that may affect the assessment of anxiety or affective state.
- Patients with cognitive impairment that prevents understanding of the study procedures or completion of the questionnaires.
- Patients with significant hearing or visual impairment that prevents them from watching or hearing the intervention video.
- Patients who have previously participated in the study. Patients who decline to participate or withdraw their informed consent at any stage of the study.
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 |
|---|---|---|
| Humor-Based Video InterventionAlso: Humor VideoA single approximately 20-minute humor-based video intervention administered during the preoperative period to patients scheduled for elective laparoscopic cholecystectomy. The video contains humorous and entertaining content designed to divert attention from surgery-related stress, reduce preoperative anxiety and negative affect, and enhance positive affect. The intervention is provided in addition to routine preoperative care and education. | Behavioural | Humor-Based Video Intervention, Routine Care and Education |
| Routine Preoperative Care and EducationAlso: Standard CareRoutine preoperative care and education provided according to the standard clinical practice of the general surgery clinic for patients undergoing elective laparoscopic cholecystectomy. This includes usual preoperative information and education provided to patients as part of standard care. No humor-based video intervention is provided to participants in this group. | Behavioural | Humor-Based Video Intervention, Routine Care and Education |
Primary outcome
Preoperative State Anxiety
Time frame: Baseline (immediately before the intervention) and immediately after the intervention, before surgery.
Change in preoperative state anxiety measured using the State-Trait Anxiety Inventory-State subscale (STAI-State). Higher scores indicate greater state anxiety.
3 secondary outcomes
Positive Affect
Time frame: Baseline (immediately before the intervention) and immediately after the intervention, before surgery.
Negative Affect
Time frame: Baseline (immediately before the intervention) and immediately after the intervention, before surgery.
Postoperative Quality of Recovery
Time frame: 24 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Humor-Based Video Intervention and Routine Preoperative Care and Education in people with Preoperative Anxiety and Laparoscopic Cholecystectomy, run by Başakşehir Çam & Sakura City Hospital 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 0 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Preoperative State Anxiety (time frame: Baseline (immediately before the intervention) and immediately after the intervention, before surgery.). 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 6 Oct 2026.