AnxietyNCT07051616
The Effect of Children's Laughter Video on Oncology Patient
A study testing Child laughter video in people with Anxiety and Chemotherapy Effect, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effect of video playback of children's laughter on anxiety, nausea, vomiting and fatigue levels of patients during chemotherapy Read more about this study
- Who is it for?
- Ages 32 to 81 years
- Conditions the study is for
- Anxiety, Chemotherapy Effect, Laughter
- What is being tested?
- Child laughter video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 30 May 2025
- 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 32 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with lymphoma (preferred to have the same type of cancer)
- Receiving the R - Chop cycle protocol as chemotherapy (This cycle was preferred because of the nausea and vomiting experienced in this protocol and the duration of the treatment is 4-5 hours) (Cleveland Clinic 2025).
- Inpatient hospitalization,
- Be over 18 years of age,
- Conscious, oriented and cooperative
Who cannot join
- Don't take a different cure than R - Chop,
- Visual and hearing and cognitive impairment,
- Do not have a problem that creates a communication barrier,
- Having any psychiatric illness such as depression, euphoria and taking psychiatric medication
- Refusal to participate in the study
- Other non-pharmacological methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Children Laughter Intervention on Anxiety, Nausea, Vomiting, and Fatigue in Chemotherapy Patients - A Randomized Controlled Trial
This study was conducted to investigate the effect of video playback of children's laughter on anxiety, nausea, vomiting and fatigue levels of patients during chemotherapy
Read the detailed description
Nausea and vomiting, anxiety and fatigue due to chemotherapy can be prevented or reduced with effective nursing interventions and care. Laughter therapy is an intervention that has been used in the symptom management of individuals with cancer in recent years. Studies focusing on humor and laughter have generally been conducted among cancer patients. Humor and laughter have been shown to have both physiological, psychological and sociological benefits for patients in general. When the studies on laughter yoga are examined, it is seen that the results of laughter therapy applied to individuals are examined. It has also been reported in the literature that laughter has a contagious effect, often occurring in groups of people. There is no study in the literature on the effect of children's laughter on adults. This study will reveal the effectiveness of infant and child laughter in patients receiving chemotherapy. It is thought that this study will constitute an important data source for experimental studies to be conducted.
- Being tested
- Child laughter video
- Medical subject headings
- Anxiety Disorders, Laughter, Fatigue, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child laughter videoBehavioural
1 hour after the chemotherapy treatment was started, the video monitor was placed at a height where the patient could see comfortably while lying down and the video, which was checked and prepared beforehand, was turned on full screen. The appropriate volume was adjusted and the patient was allowed to watch the video for 10 minutes without any other intervention. The video was then stopped and the etagere was removed from in front of the patient. Chemotherapy was continued. At the 2nd hour of chemotherapy, the disinfected etagere and computer were placed in a position where the patient could see them comfortably and the 2nd video was started and the patient was allowed to watch the video for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Child laughter video group | Experimental | Patients in this group were made to watch the laughter video prepared by the researchers at the end of the 1st and 2nd hour after the start of chemotherapy. Receives: Behavioral: Child laughter video |
| Control Group | No intervention | Participants in the control group were not subjected to any intervention other than routine practice during chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient information form
The form was designed by the researchers in two parts to assess personal characteristics and characteristics related to the disease and treatment.
Measured: First measurement-10. minutes before the start of the patient's chemotherapy
Spielberger State Anxiety Scale
The scale measures the level of status anxiety of the patient with 20 questions.this form was applied in the pre-test and post-test phase
Measured: First measurement- 5 minutes before the start of the patient's chemotherapy
FACIT Fatigue Scale
Developed by Singh in 2014, the scale was developed to evaluate the relationship between anemia and fatigue in cancer patients and to meet the increasing demand. This form was applied in the pre-test and post-test phase.
Measured: First measurement- 1 minutes before the start of the patient's chemotherapy
Physiological Parameter Follow-up Form (Heart rate-min)
This form was created by researchers. When chemotherapy started and measured at the beginning of each hour.
Measured: As soon as chemotherapy is started (Within first five minute)
Physiological Parameter Follow-up Form (Respiration rate- min)
This form was created by researchers. When chemotherapy started and measured at the beginning of each hour.
Measured: As soon as chemotherapy is started (Within first five minute)
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
This form was created by researchers. When chemotherapy started and measured at the beginning of each hour.
Measured: As soon as chemotherapy is started (Within first five minute)
Physiological Parameter Follow-up Form (blood pressure- mmHg)
This form was created by researchers. When chemotherapy started and measured at the beginning of each hour.
Measured: As soon as chemotherapy is started (Within first five minute)
Nausea Follow-up Form
With this form, the presence or absence of the patient's nause was questioned.Nausea was first measured at the start of chemotherapy
Measured: As soon as chemotherapy is started (Within first five minute)
Vomiting Follow-up Form
With this form, the presence or absence of the patient's vomiting was questioned. Vomiting was first measured at the start of chemotherapy
Measured: As soon as chemotherapy is started (Within first five minute)
Secondary outcomes (24)
Physiological Parameter Follow-up Form (Heart rate-min)
The measurement was made immediately after the first hour was full.
Measured: Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
The measurement was made immediately after the first hour was full.
Measured: Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
The measurement was made immediately after the first hour was full.
Measured: Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
The measurement was made immediately after the first hour was full.
Measured: Second measurement: 1. hour after starting chemotherapy
Nausea Follow-up Form
The measurement was made immediately after the first hour was full.
Measured: Second measurement: 1. hour after starting chemotherapy
Vomiting Follow-up Form
The measurement was made immediately after the first hour was full.
Measured: Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Heart rate-min)
The measurement was made immediately after the second hour was full.
Measured: Third measurement: 2. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
The measurement was made immediately after the second hour was full.
Measured: Third measurement: 2. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
The measurement was made immediately after the second hour was full.
Measured: Third measurement: 2. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
The measurement was made immediately after the second hour was full.
Measured: Third measurement: 2. hour after starting chemotherapy
Nausea Follow-up Form
The measurement was made immediately after the second hour was full.
Measured: Third measurement: 2. hour after starting chemotherapy
Vomiting Follow-up Form
The measurement was made immediately after the second hour was full.
Measured: Third measurement: 2. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Heart rate-min)
The measurement was made immediately after the third hour was full.
Measured: Fourth measurement: 3. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
The measurement was made immediately after the third hour was full.
Measured: Fourth measurement: 3. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
The measurement was made immediately after the third hour was full.
Measured: Fourth measurement: 3. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
The measurement was made immediately after the third hour was full.
Measured: Fourth measurement: 3. hour after starting chemotherapy
Nausea Follow-up Form
The measurement was made immediately after the third hour was full.
Measured: Fourth measurement: 3. hour after starting chemotherapy
Vomiting Follow-up Form
The measurement was made immediately after the third hour was full.
Measured: Fourth measurement: 3. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Heart rate-min)
The measurement was made immediately after the fourth hour was full.
Measured: Fifth measurement: 4. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
The measurement was made immediately after the fourth hour was full.
Measured: Fifth measurement: 4. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
The measurement was made immediately after the fourth hour was full.
Measured: Fifth measurement: 4. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
The measurement was made immediately after the fourth hour was full.
Measured: Fifth measurement: 4. hour after starting chemotherapy
Nausea Follow-up Form
The measurement was made immediately after the fourth hour was full.
Measured: Fifth measurement: 4. hour after starting chemotherapy
Vomiting Follow-up Form
The measurement was made immediately after the fourth hour was full.
Measured: Fifth measurement: 4. hour after starting chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start15 Sep 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, Prof, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051616
- Sponsor's protocol ID
- 2025/25
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Children Laughter Intervention on Anxiety, Nausea, Vomiting, and Fatigue in Chemotherapy Patients - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07051616
- Acronym / sponsor ID
- 2025/25
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 4 Jul 2025 (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 was conducted to investigate the effect of video playback of children's laughter on anxiety, nausea, vomiting and fatigue levels of patients during chemotherapy
Detailed description
Nausea and vomiting, anxiety and fatigue due to chemotherapy can be prevented or reduced with effective nursing interventions and care. Laughter therapy is an intervention that has been used in the symptom management of individuals with cancer in recent years. Studies focusing on humor and laughter have generally been conducted among cancer patients. Humor and laughter have been shown to have both physiological, psychological and sociological benefits for patients in general. When the studies on laughter yoga are examined, it is seen that the results of laughter therapy applied to individuals are examined. It has also been reported in the literature that laughter has a contagious effect, often occurring in groups of people. There is no study in the literature on the effect of children's laughter on adults. This study will reveal the effectiveness of infant and child laughter in patients receiving chemotherapy. It is thought that this study will constitute an important data source for experimental studies to be conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child laughter video group | Experimental | Behavioral: Child laughter videoPatients in this group were made to watch the laughter video prepared by the researchers at the end of the 1st and 2nd hour after the start of chemotherapy. |
| Control Group | No intervention | –Participants in the control group were not subjected to any intervention other than routine practice during chemotherapy. |
Who may qualify
- Ages
- 32 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with lymphoma (preferred to have the same type of cancer)
- Receiving the R - Chop cycle protocol as chemotherapy (This cycle was preferred because of the nausea and vomiting experienced in this protocol and the duration of the treatment is 4-5 hours) (Cleveland Clinic 2025).
- Inpatient hospitalization,
- Be over 18 years of age,
- Conscious, oriented and cooperative
Key exclusion criteria (6 listed)
- Don't take a different cure than R - Chop,
- Visual and hearing and cognitive impairment,
- Do not have a problem that creates a communication barrier,
- Having any psychiatric illness such as depression, euphoria and taking psychiatric medication
- Refusal to participate in 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 |
|---|---|---|
| Child laughter video1 hour after the chemotherapy treatment was started, the video monitor was placed at a height where the patient could see comfortably while lying down and the video, which was checked and prepared beforehand, was turned on full screen. The appropriate volume was adjusted and the patient was allowed to watch the video for 10 minutes without any other intervention. The video was then stopped and the etagere was removed from in front of the patient. Chemotherapy was continued. At the 2nd hour of chemotherapy, the disinfected etagere and computer were placed in a position where the patient could see them comfortably and the 2nd video was started and the patient was allowed to watch the video for 10 minutes. | Behavioural | Child laughter video group |
Primary outcome
Patient information form
Time frame: First measurement-10. minutes before the start of the patient's chemotherapy
The form was designed by the researchers in two parts to assess personal characteristics and characteristics related to the disease and treatment.
Spielberger State Anxiety Scale
Time frame: First measurement- 5 minutes before the start of the patient's chemotherapy
The scale measures the level of status anxiety of the patient with 20 questions.this form was applied in the pre-test and post-test phase
FACIT Fatigue Scale
Time frame: First measurement- 1 minutes before the start of the patient's chemotherapy
Developed by Singh in 2014, the scale was developed to evaluate the relationship between anemia and fatigue in cancer patients and to meet the increasing demand. This form was applied in the pre-test and post-test phase.
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: As soon as chemotherapy is started (Within first five minute)
This form was created by researchers. When chemotherapy started and measured at the beginning of each hour.
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: As soon as chemotherapy is started (Within first five minute)
This form was created by researchers. When chemotherapy started and measured at the beginning of each hour.
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: As soon as chemotherapy is started (Within first five minute)
This form was created by researchers. When chemotherapy started and measured at the beginning of each hour.
Physiological Parameter Follow-up Form (blood pressure- mmHg)
Time frame: As soon as chemotherapy is started (Within first five minute)
This form was created by researchers. When chemotherapy started and measured at the beginning of each hour.
Nausea Follow-up Form
Time frame: As soon as chemotherapy is started (Within first five minute)
With this form, the presence or absence of the patient's nause was questioned.Nausea was first measured at the start of chemotherapy
Vomiting Follow-up Form
Time frame: As soon as chemotherapy is started (Within first five minute)
With this form, the presence or absence of the patient's vomiting was questioned. Vomiting was first measured at the start of chemotherapy
24 secondary outcomes
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
Time frame: Second measurement: 1. hour after starting chemotherapy
Nausea Follow-up Form
Time frame: Second measurement: 1. hour after starting chemotherapy
Vomiting Follow-up Form
Time frame: Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Third measurement: 2. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Third measurement: 2. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Third measurement: 2. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
Time frame: Third measurement: 2. hour after starting chemotherapy
Nausea Follow-up Form
Time frame: Third measurement: 2. hour after starting chemotherapy
Vomiting Follow-up Form
Time frame: Third measurement: 2. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Fourth measurement: 3. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Fourth measurement: 3. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Fourth measurement: 3. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
Time frame: Fourth measurement: 3. hour after starting chemotherapy
Nausea Follow-up Form
Time frame: Fourth measurement: 3. hour after starting chemotherapy
Vomiting Follow-up Form
Time frame: Fourth measurement: 3. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Fifth measurement: 4. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Fifth measurement: 4. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Fifth measurement: 4. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
Time frame: Fifth measurement: 4. hour after starting chemotherapy
Nausea Follow-up Form
Time frame: Fifth measurement: 4. hour after starting chemotherapy
Vomiting Follow-up Form
Time frame: Fifth measurement: 4. hour after starting chemotherapy
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 4 Jul 2025.
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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.
Sibel Kucukoglu, Prof principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child laughter video in people with Anxiety and Chemotherapy Effect, run by Selcuk University 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 6 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 4 Jul 2025. 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?
Patient information form (time frame: First measurement-10. minutes before the start of the patient's chemotherapy). The study lists 9 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 4 Jul 2025.