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临床试验/NCT07374887
NCT07374887已完成不适用

Short Term and Long Term Impact of Snoezelen Intervention and Reminiscence Therapy on Emotionality and Anxiety and the Dynamics of Their Change in Older Adults in Slovak Elderly Care Facilities

Matej Bel University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002)

研究概览

简要总结

The aim of the study is to verify and compare the short-term and long-term effectiveness (retention) of Snoezelen intervention and reminiscence therapy and to analyze the dynamics of changes in the level of emotionality and anxiety of seniors in experimental groups and the control group.

The main question is:

There are significant differences in the level of emotionality (negative and positive emotional states) and anxiety between the two experimental groups of seniors and the control group of seniors during the measurements (pre-test measurement vs. retest measurement I; pre-test measurement vs. retest measurement II; retest measurement vs. retest measurement II)?

Researchers will compare seniors receiving Snoezelen intervention, those receiving Reminiscence Therapy, and a control group without intervention to see if the interventions lead to measurable improvements in emotionality and anxiety.

Participants will take part in Snoezelen sessions, take part in Reminiscence Therapy sessions, complete pretest, retest and retest II assessments measuring emotionality and anxiety.

详细描述

The study was registered retrospectively due to a limited awareness of the requirement to register behavioural interventions at the time of its initiation in 2022/2023. Initially conceived as a small-scale exploratory project, formal trial registration was not deemed necessary in the early planning stages.

As a doctoral student and early-career researcher, I was initially unaware that behavioural intervention studies also require formal registration. However, as the research progressed and its scope and significance became clearer, I recognised the importance of fulfilling this requirement. Upon learning of the relevant guidelines, I promptly took the necessary steps to complete the registration.

Although registration occurred at a later stage, the study was carried out in accordance with a pre-specified protocol, strictly adhering to methodological and ethical standards-approved, for instance, by the Ethics Committee of Matej Bel University. The hypotheses, study design, and analysis plan were defined prior to data collection, thereby ensuring the rigour, integrity, and transparency of the research process.

Funded by the EU NextGenerationEU through the Recovery and Resilience Plan for Slovakia under the project No. 09I03-03-V05-0000.

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
None

入排标准

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

入选标准

  • long-term residence in the facility,
  • age over 62,
  • willingness to participate,
  • ability to participate (no severe cognitive or physical impairments)
  • Inclusion Criteria for Snoezelen:
  • mentioned above
  • participants who have undergone Reminiscence therapy as part of previous research

排除标准

  • significant physical problems,
  • significant mental health problems,
  • unwillingness to participate

研究组 & 干预措施

Snoezelen intervention

Experimental

The Snoezelen intervention involved 20 participants in the pre-test and re-test, and 16 participants in the re-test.

干预措施: Snoezelen intervention (Other)

Reminiscence therapy

Experimental

The reminiscence therapy involved 20 seniors in the pre-test and re-test, and 18 seniors in the re-test II.

干预措施: Reminiscence therapy (Other)

Control group

No Intervention

The control group did not participate in any of the interventions.

结局指标

主要结局

The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002)

时间窗: from participant enrollment to data collection after 8 months

The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka \& Dalbert, 2002) was used to examine the short-term effectiveness of the intervention programme. The self-esteem scale maps the frequency of experiencing positive and negative emotions, totalling 10. Negative emotional experiencing consists of six emotions such as anger, guilt, fear, pain, sadness, and shame, positive emotional experiencing consists of pleasure, physical freshness, joy, and happiness. The participants responded on a six-point scale (6 - almost always; 1 - almost never). The total score of negative emotions is the sum of negative emotions, and the total score of positive emotions is the sum of positive emotions (Džuka et al., 2021).

The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980)

时间窗: from participant enrollment to data collection after 8 months

The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980), specifically only the anxiety portion of the questionnaire, i.e., the Scale for the Measurement of Anxiety as a Condition, STAI X-1. This is the self-assessment portion of the questionnaire, which maps the degree of current experience of feelings of tension, tenseness, nervousness, fear, and apprehension. It contains 20 statements, some of which relate to the existence of these feelings and some of which relate to their absence. Seniors rated their experiencing on a four-point scale (4 - very, 1 - not at all). We based the norms on those presented in the manual by Ruisel et al. (1980).The result is a total score, which is obtained by summing the values on the scale taking into account reverse scaling. The range of the total score is 20-80.

次要结局

  • Reflection Questionnaire (Ďuricová, 2023)(one month)

研究者

发起方
Matej Bel University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana Ďuricová

Principal Investigator

Matej Bel University

研究点 (1)

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