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Completed

NCT Number: NCT07051616

The Effect of Children's Laughter Video on Oncology Patient

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

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Chemotherapy Effect Communication Fatigue Laughter Mental Disorders Nausea Nonverbal Communication Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

32 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sibel Küçükoğlu

Selçuklu, Akademi Mahallesi, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Child laughter video

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

Secondary outcomes

  1. Physiological Parameter Follow-up Form (Heart rate-min)

    Time frame: Second measurement: 1. hour after starting chemotherapy

    The measurement was made immediately after the first hour was full.

  2. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Second measurement: 1. hour after starting chemotherapy

    The measurement was made immediately after the first hour was full.

  3. Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

    Time frame: Second measurement: 1. hour after starting chemotherapy

    The measurement was made immediately after the first hour was full.

  4. Physiological Parameter Follow-up Form (blood pressure- mmHg)

    Time frame: Second measurement: 1. hour after starting chemotherapy

    The measurement was made immediately after the first hour was full.

  5. Nausea Follow-up Form

    Time frame: Second measurement: 1. hour after starting chemotherapy

    The measurement was made immediately after the first hour was full.

  6. Vomiting Follow-up Form

    Time frame: Second measurement: 1. hour after starting chemotherapy

    The measurement was made immediately after the first hour was full.

  7. Physiological Parameter Follow-up Form (Heart rate-min)

    Time frame: Third measurement: 2. hour after starting chemotherapy

    The measurement was made immediately after the second hour was full.

  8. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Third measurement: 2. hour after starting chemotherapy

    The measurement was made immediately after the second hour was full.

  9. Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

    Time frame: Third measurement: 2. hour after starting chemotherapy

    The measurement was made immediately after the second hour was full.

  10. Physiological Parameter Follow-up Form (blood pressure- mmHg)

    Time frame: Third measurement: 2. hour after starting chemotherapy

    The measurement was made immediately after the second hour was full.

  11. Nausea Follow-up Form

    Time frame: Third measurement: 2. hour after starting chemotherapy

    The measurement was made immediately after the second hour was full.

  12. Vomiting Follow-up Form

    Time frame: Third measurement: 2. hour after starting chemotherapy

    The measurement was made immediately after the second hour was full.

  13. Physiological Parameter Follow-up Form (Heart rate-min)

    Time frame: Fourth measurement: 3. hour after starting chemotherapy

    The measurement was made immediately after the third hour was full.

  14. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Fourth measurement: 3. hour after starting chemotherapy

    The measurement was made immediately after the third hour was full.

  15. Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

    Time frame: Fourth measurement: 3. hour after starting chemotherapy

    The measurement was made immediately after the third hour was full.

  16. Physiological Parameter Follow-up Form (blood pressure- mmHg)

    Time frame: Fourth measurement: 3. hour after starting chemotherapy

    The measurement was made immediately after the third hour was full.

  17. Nausea Follow-up Form

    Time frame: Fourth measurement: 3. hour after starting chemotherapy

    The measurement was made immediately after the third hour was full.

  18. Vomiting Follow-up Form

    Time frame: Fourth measurement: 3. hour after starting chemotherapy

    The measurement was made immediately after the third hour was full.

  19. Physiological Parameter Follow-up Form (Heart rate-min)

    Time frame: Fifth measurement: 4. hour after starting chemotherapy

    The measurement was made immediately after the fourth hour was full.

  20. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Fifth measurement: 4. hour after starting chemotherapy

    The measurement was made immediately after the fourth hour was full.

  21. Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

    Time frame: Fifth measurement: 4. hour after starting chemotherapy

    The measurement was made immediately after the fourth hour was full.

  22. Physiological Parameter Follow-up Form (blood pressure- mmHg)

    Time frame: Fifth measurement: 4. hour after starting chemotherapy

    The measurement was made immediately after the fourth hour was full.

  23. Nausea Follow-up Form

    Time frame: Fifth measurement: 4. hour after starting chemotherapy

    The measurement was made immediately after the fourth hour was full.

  24. Vomiting Follow-up Form

    Time frame: Fifth measurement: 4. hour after starting chemotherapy

    The measurement was made immediately after the fourth hour was full.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

The Impact of Children Laughter Intervention on Anxiety, Nausea, Vomiting, and Fatigue in Chemotherapy Patients - A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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