Activation Programme's Impact on Seniors' Emotionality and Loneliness

NCT ID: NCT06866015

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2021-03-30

Brief Summary

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.

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.

Conditions

Emotional States; Loneliness; Seniors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Activation-socialization interventiom programme

Group Type: EXPERIMENTAL

Activation-socialization intervention programme

Intervention Type: OTHER

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.

Interventions

Activation-socialization intervention 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diana Ďuricová

OTHER

Sponsor Role: lead

Responsible Party

Diana Ďuricová

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Diana Ďuricová, PhDr.

Role: PRINCIPAL_INVESTIGATOR

Matej Bel University

Lenka Ďuricová, doc., Mgr., PhD.

Role: STUDY_DIRECTOR

Matej Bel University

Locations

Hriňovčan care facility for older adults

Hriňová, Slovakia, Slovakia

Countries

Slovakia

Related Links

https://drive.google.com/file/d/1gefKmpjoTjGglB4BKxEhkPkFWxrI7unf/view?usp=sharing

The anonymised dataset

Other Identifiers

162/2025

Identifier Type: -

Identifier Source: org_study_id