The Effect of Children's Laughter Video on Oncology Patient
The Impact of Children Laughter Intervention on Anxiety, Nausea, Vomiting, and Fatigue in Chemotherapy Patients - A Randomized Controlled Trial
1 other identifier
interventional
36
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Sep 2023
Typical duration for not_applicable anxiety
1 active site
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
September 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedFirst Submitted
Initial submission to the registry
June 25, 2025
CompletedFirst Posted
Study publicly available on registry
July 4, 2025
CompletedJuly 4, 2025
June 1, 2025
1.7 years
June 25, 2025
June 25, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
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.
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
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.
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.
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.
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.
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.
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
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
As soon as chemotherapy is started (Within first five minute)
Secondary Outcomes (24)
Physiological Parameter Follow-up Form (Heart rate-min)
Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (Respiration rate- min)
Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Second measurement: 1. hour after starting chemotherapy
Physiological Parameter Follow-up Form (blood pressure- mmHg)
Second measurement: 1. hour after starting chemotherapy
Nausea Follow-up Form
Second measurement: 1. hour after starting chemotherapy
- +19 more secondary outcomes
Study Arms (2)
Child laughter video group
EXPERIMENTALPatients 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 INTERVENTIONParticipants in the control group were not subjected to any intervention other than routine practice during chemotherapy.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sibel Küçükoğlu
Selçuklu, Akademi Mahallesi, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sibel Kucukoglu, Prof
Selcuk University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
June 25, 2025
First Posted
July 4, 2025
Study Start
September 15, 2023
Primary Completion
May 30, 2025
Study Completion
May 30, 2025
Last Updated
July 4, 2025
Record last verified: 2025-06