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临床试验/NCT07051616
NCT07051616已完成不适用

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

Selcuk University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Patient information form

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
32 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Patient information form

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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%)

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

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

时间窗: 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.

次要结局

  • Physiological Parameter Follow-up Form (Heart rate-min)(Fifth measurement: 4. hour after starting chemotherapy)
  • Physiological Parameter Follow-up Form (Respiration rate- min)(Fifth measurement: 4. hour after starting chemotherapy)
  • Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)(Fifth measurement: 4. hour after starting chemotherapy)
  • Physiological Parameter Follow-up Form (blood pressure- mmHg)(Fifth measurement: 4. hour after starting chemotherapy)
  • Nausea Follow-up Form(Fifth measurement: 4. hour after starting chemotherapy)
  • Vomiting Follow-up Form(Fifth measurement: 4. hour after starting chemotherapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Küçükoğlu

Prof

Selcuk University

研究点 (1)

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