Mindfulness-based Music Therapy in Blind Elderly Women

June 22, 2023 updated by: The Hong Kong Polytechnic University

Effects of Mindfulness-based Music Therapy on Emotional Regulation in Blind Elderly Women

This trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Hong Kong Society for the Blind

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • female
  • blind with visual acuity (the best eye) of 20/400 or below
  • aged 65 years or above
  • cognitive intact, measured using Hong Kong Montreal Cognitive Assessment (6th version) with a score ≥ 12
  • able to speak Cantonese

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mindfulness-based music therapy
Behavioral: mindfulness-based music therapy
eight weekly sessions with a combination of both mindfulness and music therapy
Experimental: mindfulness-based therapy
Behavioral: mindfulness-based therapy
eight weekly sessions of mindfulness
Active Comparator: routine care
Behavioral: routine care
eight weekly sessions of routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: at baseline
Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.
at baseline
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: In the 8th week from baseline
Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.
In the 8th week from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Anxiety Stress Scales-21 (DASS-21)
Time Frame: at baseline
Depression Anxiety Stress Scales-21 is a 21-item scale designed to assess depression, anxiety, and stress symptoms. It is divided into three subscales with each containing 7 items. Each subscale total score ranges from 0 to 21. Higher scores indicate more severe symptoms.
at baseline
Depression Anxiety Stress Scales-21 (DASS-21)
Time Frame: In the 8th week from baseline
Depression Anxiety Stress Scales-21 is a 21-item scale designed to assess depression, anxiety, and stress symptoms. It is divided into three subscales with each containing 7 items. Each subscale total score ranges from 0 to 21. Higher scores indicate more severe symptoms.
In the 8th week from baseline
Geriatric Depression Scale (GDS)
Time Frame: at baseline
Geriatric Depression Scale is a 30-item questionnaire asking how participants felt over the past week. The total score ranges from 0 to 30. Higher scores indicate more depressive symptoms.
at baseline
Geriatric Depression Scale (GDS)
Time Frame: In the 8th week from baseline
Geriatric Depression Scale is a 30-item questionnaire asking how participants felt over the past week. The total score ranges from 0 to 30. Higher scores indicate more depressive symptoms.
In the 8th week from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • RS-KHAB-2020-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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