A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness

NCT ID: NCT06382181

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Loneliness Mental Health Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants were assigned to three groups in parallel for the duration of the study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Music Therapy

Through listening to songs, singing, dancing, guided relaxation with music and instrumental group performance, the enjoyment and expression of feelings will be encouraged.

Group Type EXPERIMENTAL

Music therapy for community-dwelling individuals with unwanted loneliness

Intervention Type BEHAVIORAL

Music therapy workshops were implemented. The enjoyment and expression of feelings were encouraged by listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance. There was one session per week. Total 12 sessions.

Health education

Health education workshops

Group Type EXPERIMENTAL

Health education for community-dwelling individuals with unwanted loneliness

Intervention Type BEHAVIORAL

Twelve health education workshops were carried out. They included group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.

Physical exercise

Physical exercise adapted to the physical conditions of each participant

Group Type EXPERIMENTAL

Physical exercise for community-dwelling individuals with unwanted loneliness

Intervention Type BEHAVIORAL

This intervention was implemented with 2 group sessions each week for 13 weeks. It included physical exercise adapted to the physical conditions of each participant.

Interventions

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Music therapy for community-dwelling individuals with unwanted loneliness

Music therapy workshops were implemented. The enjoyment and expression of feelings were encouraged by listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance. There was one session per week. Total 12 sessions.

Intervention Type BEHAVIORAL

Health education for community-dwelling individuals with unwanted loneliness

Twelve health education workshops were carried out. They included group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.

Intervention Type BEHAVIORAL

Physical exercise for community-dwelling individuals with unwanted loneliness

This intervention was implemented with 2 group sessions each week for 13 weeks. It included physical exercise adapted to the physical conditions of each participant.

Intervention Type BEHAVIORAL

Other Intervention Names

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Music therapy Health education Physical exercise

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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María-Vanesa Ibáñez-del-Valle

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanessa Ibáñez del Valle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

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University of Valencia

Valencia, , Spain

Site Status

Vanessa Ibáñez del Valle

Valencia, , Spain

Site Status

Countries

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Spain

References

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Mafla-Espana MA, Corchon S, Jimeno-de Pedro P, Ibanez-Del Valle V, Cauli O. Social and Mental Health Factors Involved in the Severity of Loneliness in Older Individuals in a Spanish Rural Area. Nurs Rep. 2024 Nov 29;14(4):3737-3753. doi: 10.3390/nursrep14040273.

Reference Type DERIVED
PMID: 39728634 (View on PubMed)

Other Identifiers

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Silvia Corchón Arreche

Identifier Type: OTHER

Identifier Source: secondary_id

Omar Cauli

Identifier Type: OTHER

Identifier Source: secondary_id

2023- ENFPOD-2621979

Identifier Type: -

Identifier Source: org_study_id

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