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临床试验/NCT01414218
NCT01414218已完成不适用

Influence of Humor as a Way of Life on Well Being, Quality of Life and Immune Function

Happy Nation Society0 个研究点目标入组 92 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
主要终点
General Well Being

研究概览

简要总结

  1. Senior citizens living in the community who participate in a humor seminar will have improved health quality of life compared to those not participating in the seminar.
  2. Senior citizens living in the community who participate in a humor seminar will have improved general well being compared to those not participating in the seminar
  3. Senior citizens living in the community who participate in a humor seminar will have decreased psychological distress compared to those not participating in the seminar

详细描述

Participants for this study will be chosen from senior centers . All members of the senior centers who can read and write either Hebrew or English and are not cognitively impaired (as assessed by the administrator/social worker in charge of the center) will be asked to participate. It is estimated that between 30-50 members of each senior center will agree to participate. The control group will be chosen by convenience sampling of members from other, different senior centers. These centers will be chosen based on close geographic proximity and similar demographic characteristics to the experimental, humor group, senior centers. The choice of which center will be used for the experimental and control groups will be based on logistic considerations.

This method of sample selection and group assignment were chosen due to several considerations. At present there are approximately 60 participants in the Rishon Lezion Holocaust survivor senior center. It is highly unlikely that all of the members of the center will agree to participate in the study and/or will continue with the entire intervention. Based on a power of .80 and an alpha rate of .05, in order to detect a significant difference between two groups with a moderate effect size, a total of 64 subjects will be necessary for each of the two groups, the experimental and the control each group. Therefore, there are not enough seniors in one center to participate in either groups and additional sites for subject recruitment was found to be necessary.

A second consideration is diffusion of the treatment protocol. It is thought that if both the control and humor groups were recruited from the same senior center, then there would be the possibility that the seniors would discuss among themselves the humor intervention, thereby leading to a diffusion of treatment. In this situation, it might be hard to differentiate between those who participated in the humor and the control group. Therefore, the seniors of the control group would need to be recruited from another senior center.

This process then leads to another issue, namely selection bias, in that the control and humor groups might be different from the outset of the study. Two measures will be taken to decrease this threat to the internal validity of the study. Firstly, an attempt will be made to match the senior centers that will be used to recruit those in the control group with the senior centers used for the humor group, based on geographic location and demographic characteristics. Secondly, both the control and humor groups will be asked to complete the questionnaires at the beginning and at the end of the study. Therefore, differences will be determined between the two groups at two points in time.

Humor Program: The "Humor as a Way of Life" program will be comprised of one session per week lasting 2-3 hours per session. The program will take six months to complete. The first three months of the program will be moderated by Mr. Yochanan Waller, a known video producer and humorist. Under Mr Waller's direction, each participant will be requested to relate a humorous story or situation. These sessions will be video recorded. Between each session, Mr Waller will edit each session. At the next session, all of the participants will view all of the stories related during the previous session. Any parts of the videos that are not used for the purpose of the program will be destroyed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • attendance at a community senior center
  • ability to read and write hebrew or English

排除标准

  • * Not cognitively impaired

结局指标

主要结局

General Well Being

时间窗: after 6 months

General Well Being as measured by the General Well Being Scale

Psychological Distress

时间窗: after 6 months

Psychological distress as measured by the Brief Symptom Inventory

Health Quality of Life

时间窗: after 6 months

Health Quality of Life as measured by the Rand Health Survey

次要结局

未报告次要终点

研究者

发起方
Happy Nation Society
申办方类型
Other

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