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Clinical Trials/NCT06382181
NCT06382181
Completed
Not Applicable

A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness: Music Therapy, Health Education, and Physical Exercise

University of Valencia2 sites in 1 country20 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Loneliness
Sponsor
University of Valencia
Enrollment
20
Locations
2
Primary Endpoint
Score on the Jong Gierveld Loneliness Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise).

Detailed Description

The proposed study will involve 4 group sessions each week for a total of 13 weeks. The program will include the following activities: Physical exercise adapted to the physical conditions of each participant. Total of 26 sessions (2 per week). Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others. Music therapy workshops. Through listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance, the enjoyment and expression of feelings will be encouraged. There will be 1 session per week. Total 12 sessions.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
July 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

María-Vanesa Ibáñez-del-Valle

Principal Investigator

University of Valencia

Eligibility Criteria

Inclusion Criteria

  • Over 60 years of age with unwanted loneliness
  • Must live in the city of Valencia
  • Must speak Spanish or Valencian (or have sufficient knowledge to be able to answer the questions in the study).

Exclusion Criteria

  • + Severe mental disorder or dementia.

Outcomes

Primary Outcomes

Score on the Jong Gierveld Loneliness Scale

Time Frame: 3 months

Social isolation was measured with the Jong Gierveld Loneliness Scale. The final score is the total score for the 11 items, with the lowest possible score being 0 (no loneliness) and the highest being 11 (severe loneliness). Three categories have been proposed based on the score: a score of 0-2 points = no loneliness; a score of 3-8 points = moderate loneliness; and a score of 9-11 points = severe loneliness.

Secondary Outcomes

  • Score on Goldberg Anxiety and Depression Scale(3 months)

Study Sites (2)

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