- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07374887
Impact of Snoezelen Intervention and Reminiscence Therapy on Seniors' Emotionality and Anxiety
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Slovakia
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Hriňová, Slovakia, Slovakia, 96205
- Hriňovčan care facility for older adults, Hriňová, Slovakia 96205
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- significant physical problems,
- significant mental health problems,
- unwillingness to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Snoezelen intervention
The Snoezelen intervention involved 20 participants in the pre-test and re-test, and 16 participants in the re-test.
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Snoezelen intervention included 28 originally designed activities (Ďuricová, 2026a).
The ideas were incorporated into the daily schedule of older adults over a period of four weeks, during weekdays.
In Hriňovčan care facility, within the Snoezelen environment, two consecutive activities were carried out daily (with a total duration of 60 minutes), during the afternoon hours.
The selection of activities depended on the interests of the older adults.
Their application was neither strictly determined nor rigidly organised.
Clients participated in the Snoezelen sessions in groups of 5-6 members.
The activities were facilitated by trained staff - social worker and instructor of social rehabilitation.
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Experimental: Reminiscence therapy
The reminiscence therapy involved 20 seniors in the pre-test and re-test, and 18 seniors in the re-test II.
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Reminiscence therapy included 13 activities (Ďuricová, 2026b).
Activities were also incorporated into the daily schedule over a period of four weeks, during weekdays.
In the Hriňovčan care facility, one activity was conducted daily (lasting 60 minutes) in the common room during designated morning and afternoon hours.
The selection and implementation of the activities were strictly determined and organised.
The older adults participated in a group setting, with 20 members.
The activities were led by two social workers who participated in training with the author of the programme.
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No Intervention: Control group
The control group did not participate in any of the interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002)
Time Frame: from participant enrollment to data collection after 8 months
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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).
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from participant enrollment to data collection after 8 months
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The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980)
Time Frame: from participant enrollment to data collection after 8 months
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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.
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from participant enrollment to data collection after 8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reflection Questionnaire (Ďuricová, 2023)
Time Frame: one month
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This is a questionnaire that maps client satisfaction with activities.
It includes three statements, with clients expressing their level of agreement on a three-point scale (agree - have no strong opinion - disagree) in the areas of: re participation, usefulness and disinterest in the activities.
It also includes three incomplete sentences that seniors complete at will.
Responses reflect what clients learned/how the activities helped them, what they liked most about the activities, what they would remove from the activities.
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one month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Lenka Ďuricová, doc., Mgr., PhD., Matej Bel University
- Principal Investigator: Diana Ďuricová, PhDr., Matej Bel University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGA-06-DS-2025
- 09I03-03-V05-00009 (Other Grant/Funding Number: Early stage grants - Matej Bel University in Banská Bystrica)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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