- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866015
Activation Programme's Impact on Seniors' Emotionality and Loneliness
The Impact of an Activation-Socialisation Intervention Programme on the Emotionality and Loneliness of Older Adults in Slovak Elderly Care Facilities - a Pilot Study
The goal of this pilot study is to verify the short-term effectiveness of the Activation-Socialisation Intervention Programme (A-S IP) on the psychosocial survival of older adults in a specific care facility. The main questions it aims to answer are:
- Does the A-S IP reduce the rate of negative emotional states in older adults?
- Does the A-S IP increase the rate of positive emotional states in older adults?
- Does the A-S IP reduce feelings of loneliness in older adults? Researchers will compare the experimental group (older adults participating in the A-S IP) to a control group (older adults not participating in the intervention) to assess the impact on emotional states and loneliness.
Participants will:
- Participate in 40 activities based on three domains (Laughter Therapy, Reminiscence Therapy, and Cognitive and Social Skills Stimulation)
- Engage in group activities for four weeks, with daily sessions scheduled in the morning and afternoon
- Provide feedback on their experiences through surveys and questionnaires to assess their emotional states and satisfaction with the intervention
The study will also explore whether the intervention contributes to the well-being of older adults, as measured by changes in their emotional states and feelings of loneliness.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was registered retrospectively due to limited awareness of the registration requirement for behavioral interventions at the time of study initiation (in 2021). Initially, the research was designed as an exploratory study on a smaller scale, and the registration of a formal trial was not considered necessary.
As an early-career researcher and doctoral student, I was not initially aware of the necessity of registering behavioral intervention studies. However, as the study progressed and its significance became evident, I came to understand the importance of this process. Once I became aware of the registration requirements, I took the necessary steps to complete it accordingly.
Despite the late registration, the study was conducted according to a pre-specified protocol, with all methodological and ethical standards strictly adhered to (approved, for example, by the Ethics Committee of UMB). The hypotheses, study design, and analysis plan were defined prior to data collection, ensuring the integrity and transparency of the research.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hriňová, Slovakia, 96205
- Hriňovčan care facility for older adults
-
-
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)
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Activation-socialization interventiom programme
|
The proposed A-S IP (Author, 2021) includes 40 activities of three domains focusing mainly on the social-psychological level of education: the Laughter Therapy Concept (13), the Reminiscence Therapy Concept (13), and the Cognitive and Social Skills Stimulation Intervention Concept (14). The implementation of the A-S IP activities was designed for a time period of four weeks during weekdays. In the Hriňovčan care facility for older adults, mainly in the common room, two activities were implemented daily during the morning and afternoon hours reserved for this purpose. Morning activities (active) were from 10:00 to 11:00 a.m., and afternoon activities (passive) were from 1:00 to 2:00 p.m. The application of the activities was strictly determined and organised according to a time-thematic schedule that applied rules. The participants participated in group activities, and their participation was voluntary. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the Scale of Emotional Habitual Subjective Well-being - SEHP (Džuka & Dalbert, 2002)
Time Frame: one month
|
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). An additional variable, loneliness, was added to the scale. It was assessed on an identical six-point scale. Unit of Measure: Score (Total score for positive and negative emotions) |
one month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Lenka Ďuricová, doc., Mgr., PhD., Matej Bel University
- Principal Investigator: Diana Ďuricová, PhDr., Matej Bel University
Publications and helpful links
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
Other Study ID Numbers
- 162/2025
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
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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