NCT07051616

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1.7 years

First QC Date

June 25, 2025

Last Update Submit

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

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.

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.

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.

Child laughter video group

Eligibility Criteria

Age32 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Anxiety DisordersLaughterFatigueNauseaVomiting

Condition Hierarchy (Ancestors)

Mental DisordersNonverbal CommunicationCommunicationBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Sibel Kucukoglu, Prof

    Selcuk University

    PRINCIPAL INVESTIGATOR

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

Locations